Archive for September 21st, 2012

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CE Mark for The iDesign Advanced WaveScan Studio Aberrometer

CE Mark for The iDesign Advanced WaveScan Studio Aberrometer

CE Mark for The iDesign Advanced WaveScan Studio Aberrometer

Media:

Steve Chesterman

(714) 247-8711

Financial:

Tina Ventura

(847) 935-9390

Abbott Receives CE Mark for iDesign Advanced

WaveScan Studio Aberrometer

iDesign is the industry’s most advanced, high-definition measurement device for

wavefront-guided LASIK procedures.

MILAN, Italy, September 8, 2012 – Abbott announced today it has obtained European

CE Mark for the iDesign Advanced WaveScan Studio aberrometer, a next-generation

diagnostic tool for mapping and analyzing corneal aberrations in the eye for

wavefront-guided LASIK procedures.

The iDesign system measurement makes an individual “blueprint” of the eyes,

mapping the imperfections and creating a treatment plan. Once a corneal flap is

created using the iFS Femtosecond laser, this iDesign treatment plan is then

executed using the STAR S4 IR Excimer Laser system for a computer-driven custom

laser correction, unique to each patient.

“The approval of the iDesign Advanced WaveScan Studio in Europe further enhances

the three-step iLASIK process to set a new standard for laser vision correction,” said

Jim Mazzo, senior vice president, Abbott Medical Optics. “Since the introduction of

Abbott’s iLASIK technologies, organizations with the highest standards for safety and

visual acuity, including the U.S. Military and NASA, have embraced these for their

most elite personnel, including sharpshooters, fighter pilots and astronauts because

of our exclusive, validated safety and precision performance.”

The iDesign system offers high-definition measurements and state-of-the-art

technology benefits including:

· Precise alignment for more accurate, customized corneal and wavefront

measurement;

· Five diagnostic ocular measurements within a single capture sequence that

determine the eye’s refractive error, wavefront error, corneal topography and

curvature, and pupil size, providing a more efficient workflow for the physician;

-more-

· A higher-definition wavefront sensor that can detect and map highly aberrated

corneas, maximizing ocular capture rates and potentially expanding the pool

of patients who may qualify for wavefront-guided LASIK procedures; and

· Improved ease-of-use for the physician through an enhanced graphical

interface with advanced video target aids and onscreen tools.

“The iDesign aberrometer represents a new and exciting direction for diagnostic

devices in the world of refractive surgery,” said Steve Schallhorn, M.D., Global

Medical Director of Optical Express. “Accurately measuring many important

parameters of the eye not only maximizes clinical efficiency for the physician, but also

allows patients with highly blurred or distorted vision, the benefits of a truly

customized, wavefront guided LASIK procedure.”

The iDesign Advanced WaveScan Studio aberrometer was tested in a clinical study

for patient safety and effectiveness with positive outcomes.

“We were extremely pleased with the operation of the iDesign aberrometer, and

patients treated in the clinical study, where it was used to map their eyes, were some

of the most satisfied patients we’ve seen to date,” said Bruce Jackson, M.D. clinical

investigator, University of Ottawa Eye Institute. “The iDesign Advanced WaveScan

Studio also allows physicians to capture a wider range of myopic patients than any

other aberrometer in my experience.”

Clinical trials to support United States registration for the iDesign Advanced

WaveScan Studio aberrometer have recently commenced at several sites across the

country.

About Abbott Medical Optics (AMO)

Abbott Medical Optics is focused on delivering life-improving vision technologies to

people of all ages. The company offers a comprehensive portfolio of cataract,

refractive and eye care products. Products in the cataract line include monofocal and

multifocal intraocular lenses (IOLs), phacoemulsification systems, viscoelastics, and

related products used in ocular surgery. Products in the refractive line include

wavefront diagnostic devices, femtosecond lasers and associated patient interface

devices; excimer laser vision correction systems and treatment cards. Products in the

eye care line include disinfecting solutions, enzymatic cleaners, lens rewetting drops

and artificial tears.

-more-

For more information, please visit www.abbottmedicaloptics.com.

About Abbott

Abbott is a global, broad-based health care company devoted to the discovery,

development, manufacture and marketing of pharmaceuticals and medical products,

including nutritionals, devices and diagnostics. The company employs approximately

90,000 people and markets its products in more than 130 countries.

Abbott’s news releases and other information are available on the company’s Web

site at www.abbott.com.

Abbott Medical Optics’ iDesign Advanced WaveScan Studio Aberrometer has been awarded CE Mark. The device is a diagnostic tool used to map and assess corneal aberrations in the eye for wavefront-guided LASIK procedures. By making a “blueprint”, the device is able to map out the cornea with its aberrations and set out a treatment plan, which is custom-based per patient and computer-driven.

The device provides precise alignment for accurate wavefront measurements and its ability to map highly aberrated corneas potentially expands the number of possible patients that may qualify for the procedure. The device is to have more user-friendly features for physicians to promote ease of use.

Studies in the United States are currently under way.

source : http://cdn./ABT-CE-Mark-Approval-iDesign_FINALx.pdf

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Kickstart Orthosis Assists in Walking Using Elegant Unpowered Mechanics

Kickstart Orthosis Assists in Walking Using Elegant Unpowered Mechanics

Kickstart Orthosis Assists in Walking Using Elegant Unpowered Mechanics

Cadence Biomedical of Seattle, WA today released its Kickstart Kinetic Orthosis, a device that helps people with neurological disorders affecting the strength of their legs walk with greater ease and precision. It stores energy during flexing of the knee and releases it to help propel the foot forward during extension. According to the company, the Kickstart was “inspired by the anatomy of horses, whose long tendons span multiple joints and allow for highly efficient walking and running.”

Since it’s not powered, it doesn’t require heavy batteries that need to be recharged, nor motors that make noise and complicate the mechanics, and can be used on one or both legs depending on the patient’s needs.

More about the Kickstart from Cadence Biomedical:

Kickstart is designed to bring new levels of function for those who have plateaued in therapy, and also open new opportunities for supporting recovery and an enhanced quality of life. A growing body of clinical data speaks to its benefits, including case studies presented at this year’s annual meetings of the American Academy of Orthotists and Prosthetists (AAOP) and the American Orthotic and Prosthetic Association (AOPA), in which Kickstart users were able to walk considerably farther and faster while using the device. Cadence is conducting clinical studies aimed at further quantifying Kickstart’s benefits with partner academic institutions and expects to begin reporting data in 2013.

Kickstart is specifically intended for individuals with lower extremity weakness – particularly in the hip flexors and ankle plantarflexors – and poor endurance, secondary to neurological injury or disease such as stroke, incomplete spinal cord injury, ALS, muscular dystrophy and multiple sclerosis. The device is worn over clothing, and unilateral and bilateral configurations are available. Kickstart is prescribed by a physician and custom-fit by an orthotist.

SEATTLE–(BUSINESS WIRE)–Cadence Biomedical, a developer of medical devices that help people with severe disabilities walk, today announced the launch and commercial availability of its first product, the Kickstart™ Kinetic Orthosis. Kickstart is a revolutionary wearable device that can help individuals with weakened muscles or disabilities regain mobility and independence. Following a pilot program that was well received by physical therapists, orthotists, and users, Kickstart is now available commercially in the United States.

“Incorporating Kickstart into my practice was a straightforward and simple process, and patients and their supporting family members alike have provided positive feedback on their experiences”

“More than two million Americans suffer from severe mobility impairment, and many are underserved by current mobility assistance devices,” said Brian Glaister, president and chief executive officer of Cadence Biomedical. “Kickstart represents an elegant and effective alternative to existing leg braces, which are limited and inflexible, and to robotic devices, which are cumbersome and impractical for daily life. The response from Kickstart early adopter users and clinicians has been overwhelmingly positive, and we are excited to now bring Kickstart to an even wider audience.”

Kickstart uniquely stores and releases a user’s own energy to provide walking assistance, improve stability, and enhance physical therapy for those recovering from strokes, partial spinal cord injuries, and other conditions that affect mobility. Unlike robotic devices, there are no batteries, motors, or noises associated with its use. Kickstart was inspired by the anatomy of horses, whose long tendons span multiple joints and allow for highly efficient walking and running.

“Neurological injuries such as stroke and spinal cord injury often result in severe weakness to the muscles of the leg, which are critical for mobility,” said Jim Lynskey, PT, Ph.D., associate professor at A.T. Still University in Mesa, Arizona, and an expert on physical therapy and neurological impairment. “Kickstart is unique in its ability to assist the hip flexors, the set of muscles that work together to lift the leg and swing through to complete a step. Few mobility impairment aids support and assist this process specifically, which means Kickstart could be an important addition to the physical therapist and fellow providers’ toolset.”

Kickstart is designed to bring new levels of function for those who have plateaued in therapy, and also open new opportunities for supporting recovery and an enhanced quality of life. A growing body of clinical data speaks to its benefits, including case studies presented at this year’s annual meetings of the American Academy of Orthotists and Prosthetists (AAOP) and the American Orthotic and Prosthetic Association (AOPA), in which Kickstart users were able to walk considerably farther and faster while using the device. Cadence is conducting clinical studies aimed at further quantifying Kickstart’s benefits with partner academic institutions and expects to begin reporting data in 2013.

“Incorporating Kickstart into my practice was a straightforward and simple process, and patients and their supporting family members alike have provided positive feedback on their experiences,” said John Shaffer, LPO, CPO, Partner at American Artificial Limb Co. in Seattle, Washington, an early provider of the device. “From my perspective, the device addresses an unmet need and will be a welcome addition to my practice.”

Kickstart is specifically intended for individuals with lower extremity weakness – particularly in the hip flexors and ankle plantarflexors – and poor endurance, secondary to neurological injury or disease such as stroke, incomplete spinal cord injury, ALS, muscular dystrophy and multiple sclerosis. The device is worn over clothing, and unilateral and bilateral configurations are available. Kickstart is prescribed by a physician and custom-fit by an orthotist. Clinicians interested in learning more about Kickstart can contact the Cadence team by phone at (206) 659-0614 or via online form.

About Cadence Biomedical

Cadence Biomedical, headquartered in Seattle, Washington, is a medical device company that is committed to helping the 2.3 million Americans who suffer severe mobility impairments to gain a more mobile and independent life. Cadence develops and markets the Kickstart, first in a new class of Kinetic Orthosis devices, which provides stability and movement assistance to weakened muscles without the use of powered mechanisms. For more information, please visit www.cadencebiomedical.com, www.twitter.com/cadencebio, and www.facebook.com/cadencebio.

Rediscover your ability to walk

Introducing Kickstart, a new custom orthosis designed to help you surpass your limitations and get back to the daily activities you love most.

Kickstart provides immediate walking assistance, improves stability and enhances physical therapy for those recovering from strokes, partial spinal cord injuries and other conditions that affect walking. The device is designed to bring new levels of function for those who have plateaued in therapy and opens new opportunities for supporting recovery and an enhanced quality of life.

Source : http://www.businesswire.com/news/home/20120919005955/en

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Remotoscope, an iPhone Otoscope Inching Closer towards Commercialization

Remotoscope, an iPhone Otoscope Inching Closer towards Commercialization

Remotoscope, an iPhone Otoscope Inching Closer towards Commercialization

In 2008, we first heard about the mobile microscope from CellScope (San Francisco), which came out of research at the University of California, Berkeley. One of the most impressive elements of the technology is that it could be used for a number of medical applications in everything from dermatology to oncology, potentially offering a diagnostic tool to physicians in remote areas across the planet. In addition, its microscope technology has the potential to turn the iPhone into an otoscope, which could enable the remote diagnosis of ear infections. In the United States, ear infections account for roughly 30 million doctor’s visits annually. At present, CellScope is running pilot trials in preparation for a market launch of its iPhone-based otoscopes and dermascopes.

Georgia Tech recently issued a press release describing its involvement in the development of the Remotoscope—a clip-on attachment and app combination that transforms the iPhone into an otoscope. The device uses the iPhone’s camera and flash to provide light for otoscopic images.

From the press release:

Remotoscope has had a long journey with many players to get to where it is today. Dr. [Wilbur] Lam and a colleague, Erik Douglas, started the project while doctoral students at UC, Berkeley. The two researchers went on to create the startup CellScope Inc., which aims to commercialize Remotoscope once clinical studies are complete and the device has FDA approval.

In 2011, when Dr. Lam joined the faculty at Georgia Tech and Emory, he brought the project with him to Atlanta. Today resources from both institutions, as well as Children’s Healthcare of Atlanta and the Atlanta Clinical & Translational Science Institute, are being used to take the medical device to the next level.

The Remotoscope is now being studied in a clinical trial for to compare its diagnostic quality with a traditional otoscope. The FDA, through the Atlanta Pediatric Device Consortium, is partly funding the trial. The researchers expect to publish the trial data by the end of year and hope that FDA approval will follow that milestone.

A new pediatric medical device being developed by Georgia Tech and Emory University could make life easier for every parent who has rushed to the doctor with a child screaming from an ear infection.

Soon, parents may be able to skip the doctor’s visit and receive a diagnosis without leaving home by using Remotoscope, a clip-on attachment and software app that turns an iPhone into an otoscope.

Pediatricians currently diagnose ear infections using the standard otoscope to examine the eardrum. With Remotoscope, parents would be able to take a picture or video of their child’s eardrum using the iPhone and send the images digitally to a physician for diagnostic review.

Wilbur Lam, assistant professor in the Wallace H. Coulter Department of Biomedical Engineering at Georgia Tech and Emory University, along with his colleagues at the University of California, Berkeley, is developing the device, with plans to commercialize it.

“Ultimately we think parents could receive a diagnosis at home and forgo the late-night trips to the emergency room,” said Dr. Lam, who is also a physician at Children’s Healthcare of Atlanta and an assistant professor of pediatrics at Emory School of Medicine. “It’s known that kids who get ear infections early in life are at risk for recurrent ear infections. It can be a very big deal and really affect their families’ quality of life.”

Remotoscope’s clip-on attachment uses the iPhone’s camera and flash as the light source as well as a custom software app to provide magnification and record data to the phone. The iPhone’s data transmission capabilities seamlessly send images and video to a doctor’s inbox or to the patient’s electronic medical record.

The device has the potential to save money for both families and healthcare systems, Dr. Lam said. Ear infections, or otitis media, affect 75 percent of children by age 6, making it the most common diagnosis for preschoolers. They result in more than 15 million office visits per year in the United States and thousands of prescriptions for antibiotics, which are sometimes not needed.

At the initial visit with a patient, physicians say it is difficult to differentiate between ear infections caused by viruses, which resolve on their own, and those caused by bacteria, which would require antibiotics.

“As pediatricians will likely only see the child once, they often err on the side of giving antibiotics for viral infections rather than risk not giving antibiotics for a bacterial infection, which can lead to complications,” Dr. Lam said. “So, we are currently over-treating ear infections with antibiotics and consequently causing antibiotic resistance.”

Lam said Remotoscope may be able to change physicians’ prescription patterns of antibiotics for ear infections. Receiving serial images of a child’s ear over several days via the Remotoscope could allow physicians to wait and see if a child’s infection improves or whether antibiotics are warranted.

A clinical trial for the Remotoscope is currently under way to see if the device can obtain images of the same diagnostic quality as what a physician sees with a traditional otoscope. The Food and Drug Administration, through the Atlanta Pediatric Device Consortium, is partially funding the trial. Andrea Shane, MD, assistant professor of pediatrics in Emory School of Medicine and a physician at Children’s Healthcare of Atlanta, is principal investigator of the study.

Fourth-year Emory medical student Kathryn Rappaport, who is part of the research team, is helping recruit families who come into the emergency department at Children’s Healthcare of Atlanta hospitals for treatment of ear infection-type symptoms. Once a family agrees to be in the trial and the child has seen the emergency room doctor, Rappaport takes video of the child’s ear with Remotoscope and a traditional otoscope linked to a computer. Next, a panel of physicians will review the quality of the samples, make a diagnosis from the Remotoscope video and see if it matches the original diagnosis by the ER doctor.

As part of the clinical trial, Rappaport is also conducting a survey asking parents their opinions on using the device.

“A lot of parents said they would want to use it, which surprised me because I think it could be scary to look in someone’s ear and because I think parents would be afraid they could hurt their child,” Rappaport said. “Parents are enthusiastic and ask me where they can get it, but we’re not there yet.”

The research team hopes to publish the trial’s results by the end of the year and then study whether the Remotoscope enables physicians to implement the “watchful waiting” plan rather than prescribing antibiotics right away.

Remotoscope has had a long journey with many players to get to where it is today. Dr. Lam and a colleague, Erik Douglas, started the project while doctoral students at UC, Berkeley. The two researchers went on to create the startup CellScope Inc., which aims to commercialize Remotoscope once clinical studies are complete and the device has FDA approval.

In 2011, when Dr. Lam joined the faculty at Georgia Tech and Emory, he brought the project with him to Atlanta. Today resources from both institutions, as well as Children’s Healthcare of Atlanta and the Atlanta Clinical & Translational Science Institute, are being used to take the medical device to the next level.

The Remotoscope is one of nine medical device projects supported by the Atlanta Pediatric Device Consortium, which is a partnership among Georgia Tech, Children’s Healthcare of Atlanta and Emory University. The consortium, one of four in the U.S., provides assistance with engineering design, prototype development, pre-clinical and clinical studies and commercialization for pediatric medical devices.

“The whole goal is to create, develop and commercialize pediatric medical devices specifically for kids,” Dr. Lam said. “Kids are not just small adults. Physiologically they are different. So to only have medical devices scaled down from adult ones creates this void where there are many diseases that affect only the pediatric population but there are not any available devices to treat them.”

Dr. Wilbur Lam owns equity interest in CellScope Inc., and serves in a fiduciary role for the company. Dr. Lam is a co-inventor of the Remotoscope, which is licensed to CellScope for the purposes of development and commercialization, and he is entitled to royalties derived from CellScope’s sale of products related to the research described in this press release. The terms of this arrangement have been reviewed and approved by Georgia Tech and Emory University in accordance with their conflict of interest policies.

Source : http://www.gatech.edu/newsroom/release.html?nid=155181

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U.S. Army Building 4G Communication System for Wounded Warrior Care

U.S. Army Building 4G Communication System for Wounded Warrior Care

U.S. Army Building 4G Communication System for Wounded Warrior Care

ABERDEEN PROVING GROUND, Md. (Sept. 19, 2012) — The U.S. Army explored whether real-time, electronic point-of-treatment care was possible or practical this summer at its integrated capabilities testbed at Fort Dix, N.J.

Key medical and technical personnel from the U.S. Army Medical Research & Materiel Command and the U.S. Army Research, Development and Engineering Command combined prototype medical military software with commercial hand-held technologies and tactical 4G networks to send medical information from the point of injury on the battlefield back to the doctor for real-time communication and decision making.

“It’s going to build confidence in the medic on the field that’s isolated with a severely wounded Soldier,” said Carl Manemeit, Physiological Monitoring project lead for the MRMC’s Telemedicine & Advanced Technology Research Center, or TATRC.

“If you’ve ever seen the movie, ‘Black Hawk Down,’ the medic is trying to treat the guy with the artery issue in his leg; the medic goes through all his resources, and once he exhausted all his knowledge, he was stuck,” Manemeit said. If he had been connected to the surgeons back at the treatment facility, they could have given him more guidance on how to save that Soldier’s life. By injecting this expertise, we might be able to do that one thing that could save some guy’s life; that’s what we’re looking to do.”

Medics utilized man-portable physiological monitoring devices with streaming video, voice and photo capability, and sent electronic Tactical Casualty Care Cards, or TC3, over a tactical network to the surgical facility so surgeons could see injuries and what treatment had been performed prior to the patient’s arrival.

“There’s an information gap that lies between the point of injury on the field and point of treatment back at a medical facility,” said Dr. Gary R. Gilbert, TATRC Research, Development, Test and Evaluation program manager for Secure Telemedicine. “We need to do a better job of being able to record what the medic saw and did prior to the patient being evacuated to the treatment facility, and we want this record to be transmitted to the Soldier’s permanent health records.”

“Now when the patient goes to a combat support hospital, or gets back to Walter Reed for further care, the doctors can see what happened in the field; and five years from now when the patient goes into a VA hospital seeking treatment, the care providers can see everything that’s been done,” Gilbert said.

Currently, medics fill out a paper TC3 that’s attached to the injured Soldier before evacuation to the battalion aid station or the combat support hospital. In some cases, the TC3 never makes it back to the treatment facility, and the information never makes it to the patient records.

“One of the issues I had with the card is that it’s a piece of paper held on with a metal wire,” said Spc. Daniel Vita, U.S. Army Medical Research Institute for Infectious Diseases, Fort Detrick, Md. “Pretty much, you would have attached it to the patient through his zipper or around his wrist, but you potentially had the problem of ripping the paper from the metal loop.”

Vita, who was a medic with the 130th Engineer Brigade Headquarters in Iraq, preferred using tape and a sharpie because “it stayed.”

“I like the idea of an electronic TC3 because it’s simpler,” Vita said. “It’s a lot easier for the information to get to where it needs to go and it makes it legible. When you filled out a TC3 card and put it on the patient, they didn’t know what was happening until that patient and card got to them. Now doing it electronically, you can send it ahead to the level two or three so they have an idea of what kinds of patients and casualties are coming in.”

The combination of secure tactical communications and knowledge management may also help brigade surgeons prioritize treatment and evacuation assets so the most critically injured can be treated first.

“The Army uses medevac, but the bad news is that it costs about $20,000 per patient flight,” said Dave Williams, Project Manager for Theater Tele-Health Initiatives, TATRC. “And if you have six assets and 12 patients, who should they get first? If we can determine which patients can be held and which can be treated and stabilized on site, it might be a less expensive way to save a patient’s life.”

The work was performed at the integrated capabilities testbed operated by Product Director Command, Control, Communications, Computers, Intelligence, Surveillance, Reconnaissance and Network Modernization, an R&D program within U.S. Army RDECOM’s communications-electronics RD&E center, CERDEC.

“This is a forgiving environment because it’s designed for testing and solution proving,” Gilbert said. “If things don’t work, that’s OK; you find out what doesn’t work and you fix it here. There are a lot of technologies required to make this work, and we don’t have all of these. CERDEC is helping to fill in those gaps by providing a variety of radio capabilities that you wouldn’t get at a real brigade: SRW, WNW, ANW2, deployable 4G, Airborne relay, connection to Army WIN-T. They provide the infrastructure, and we just bring the application.”

PD C4ISR & Network Modernization focuses on the future network, near-term and several years out, providing the Army with a relevant venue to assess next-generation technologies and to facilitate technology maturation. The program is also a key component in CERDEC’s support of the agile acquisition process, utilizing its field lab environment to perform risk mitigation and candidate assessment/selection for future Network Integration Rehearsal/Exercise events.

“These guys are not only preparing the current force to be successful, they’re closing the gaps for the future force with each iteration of these integrated capabilities events,” Williams said. “You don’t solve all the problems in one 12-month cycle. This venue is providing the medics an opportunity to get inside the Program Objective Memorandum cycle to come up with those solutions and iteratively solve them as technologies emerge and grow with us. This has been a complete team effort to develop a solution that did not exist six years ago.”

This is the third year that PD C4ISR & Network Modernization has examined network capabilities that could support the medic/first responder’s mission.

During 2011, PD C4ISR & Network Modernization combined fielded tactical radios such as the Enhanced Position Location Reporting System with the Soldier Radio Waveform to see if it was possible and feasible to provide enhanced bandwidth and over-the-horizon communications for hand-held medical data. This year, a 4G cellular mesh network was implemented, using SRW to bridge back to the tactical network.

“We’re examining how best to combine the future and current so we can enable the medical community to perform their mission more efficiently,” said Jason Sypniewski, chief for PD C4ISR & Network Modernization’s Integrated Event Design & Analysis branch. “We’re looking at the Soldier Radio Waveform because it’s a self-healing waveform that allows non-line-of-sight communication; that’s the vision for where the Army wants to go. We’ve looked at EPLRS because it’s an existing asset on which the medical community might could recapitalize.”

“Cellular technology could be the future of tele-health on the modern battlefield, but we need to know if it can be done, and if so, would it actually enhance the delivery of information?” Sypniewski said. “As decision makers look at network modernization, this is the type of information they will want in order to help them make informed decisions regarding telemedicine capabilities and the networks on which they’re going to ride. Our mission is to provide this.”

Battlefield medics and army docs are professional colleagues who work on the same patients, but usually in a different space and time. Medics are often faced with wounded soldiers that need immediate attention that only a trained surgeon can help with. Moreover, once the surgeon finally gets his hands on the patient, knowing the background of the injury and the subsequent medical details can dramatically speed up initialization of proper care. Additionally, triaging multiple injuries in the field by deciding who gets the medevac first can be improved if doctors at the field hospital have a good sense of what the status of the wounded is.

The U.S. Army is working on a system that can manage patient data from injury site to recovery, including providing live audio/video communication for medics in the field. The system relies on a number of devices and 4G cellular networking to send vitals to and communicate with the doctor while everything is being recorded for further review. Surely a similar system can be translated for use for civilian care and integrated into ambulances and clinics.

From the U.S. Army:

Medics utilized man-portable physiological monitoring devices with streaming video, voice and photo capability, and sent electronic Tactical Casualty Care Cards, or TC3, over a tactical network to the surgical facility so surgeons could see injuries and what treatment had been performed prior to the patient’s arrival.

The combination of secure tactical communications and knowledge management may also help brigade surgeons prioritize treatment and evacuation assets so the most critically injured can be treated first.

“The Army uses medevac, but the bad news is that it costs about $20,000 per patient flight,” said Dave Williams, Project Manager for Theater Tele-Health Initiatives, TATRC. “And if you have six assets and 12 patients, who should they get first? If we can determine which patients can be held and which can be treated and stabilized on site, it might be a less expensive way to save a patient’s life.”

This is the third year that PD C4ISR & Network Modernization has examined network capabilities that could support the medic/first responder’s mission.

During 2011, PD C4ISR & Network Modernization combined fielded tactical radios such as the Enhanced Position Location Reporting System with the Soldier Radio Waveform to see if it was possible and feasible to provide enhanced bandwidth and over-the-horizon communications for hand-held medical data. This year, a 4G cellular mesh network was implemented, using SRW to bridge back to the tactical network.

“We’re examining how best to combine the future and current so we can enable the medical community to perform their mission more efficiently,” said Jason Sypniewski, chief for PD C4ISR & Network Modernization’s Integrated Event Design & Analysis branch. “We’re looking at the Soldier Radio Waveform because it’s a self-healing waveform that allows non-line-of-sight communication; that’s the vision for where the Army wants to go. We’ve looked at EPLRS because it’s an existing asset on which the medical community might could recapitalize.”

Source : http://www.army.mil/article/87550/Army_explores_tactical_4G_telemedicine/

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Thieme Debuts Proprietary eBook App for iPad

Thieme Debuts Proprietary eBook App for iPad

Thieme Debuts Proprietary eBook App for iPad

Description

Thieme Bookshelf is the companion app to Thieme’s E-Book Store, where you can purchase from among hundreds of books specializing in the latest medical content. Browse the contents of the store or your personal library with an easy-to-use bookshelf; tap a book to open it; flip through pages with a swipe or a tap; and bookmark or add notes

Medical publisher Thieme recently debuted their own free iBooks-like app for the iPad. This is an interesting way for medical publishers to start their own eco-systems, allowing institutional and personal subscriptions that don’t rely on a single platform. Already accessible through their web portal, in the future they could expand to Android tablets or whatever else comes along. It doesn’t anchor users to Apple, but it does keep them with Thieme, and prevents the end user from selling a used copy. Like with most electronic media, users want to access their purchases with whatever device they happen to have on hand, and since most physicians are using an iPad for a tablet, Thieme seems to be responding appropriately.

The app itself is pretty basic, serving as both a bookshelf and a portal to their eBook store, but we don’t know that you would want it to do much more. It downloads purchased books through the storefront in the app, or when you sign in with your Thieme username you get access to all of the eBook versions of Thieme books you already own on other devices. The files are saved on the iPad, so you don’t need internet access once the book is downloaded. We looked at three titles that Thieme provided free for review:

Thieme bookshelf Thieme Debuts Proprietary eBook App for iPadAtlas of Anatomy

Peripheral Regional Anesthesia

Surgical Treatment of Orthopaedic Trauma

Within each book you can make bookmarks and notes, search for keywords, and alter the screen contrast. However, when a book comes with “bonus content” such as videos or DVDs there is no way to get to them within the app. The publishers tell us that they hope to add this functionality in the future. Also, there is no way to share notes or bookmarks with others who own the same book or with yourself on another device. Annoyingly, if you leave a book to go to another part of the app, when you return to the book the program does not save your place, dumping you back to the first page. This is made even more frustrating by the slowness of the app in rendering each page. We were using the latest generation iPad and it took about 3 seconds to render each page (slightly faster in landscape mode, but the text is smaller), making casual scrolling through a book very tedious. So unless you remember the exact page number you were on before exiting or made a bookmark, getting back to where you were could involve a lot of idle time.

Thieme book page Thieme Debuts Proprietary eBook App for iPad

A final minor complaint is that the title of the app itself (Thieme Bookshelf) is long enough that it has to be truncated by the iOS homescreen, so it displays as “Thieme…kshelf” when downloaded.

This sounds like a lot of complaining, but overall we like what Thieme is attempting to do. And it is definitely more convenient to carry around an iPad than three heavy books. If you already have an eBook license from Thieme for multiple books, this free app is worth downloading to your iPad, but the limitations listed above mean that if you only have a small pocket guide, it is more convenient to just carry the physical version. Especially if it is something you want to be able to access quickly and flip through to find relevant info.

Source : http://itunes.apple.com/us/app/thieme-bookshelf/id509171227

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Using Colonoscopy to Predict Parkinson’s Disease?

Using Colonoscopy to Predict Parkinson’s Disease?

Using Colonoscopy to Predict Parkinson’s Disease?

(CHICAGO) – Two studies by neurological researchers at Rush University Medical Center suggest that, in the future, colonic tissue obtained during either colonoscopy or flexible sigmoidoscopy may be used to predict who will develop Parkinson’s disease, a neurodegenerative disorder of aging that that leads to progressive deterioration of motor function due to loss of neurons in the brain that produce dopamine, a neurotransmitter essential to executing movement.

Currently, Parkinson’s disease afflicts almost 5 million people worldwide. It is projected that by 2030, Parkinson’s disease will affect over 10 million individuals.

A protein called alpha-synuclein is deposited in cells of the brain of patients with Parkinson’s disease and is considered a pathologic hallmark of the disorder. These protein aggregates form Lewy bodies, a characteristic structure seen in Parkinson’s disease brains at autopsy. Identification of the role of alpha-synuclein aggregation in neuronal dysfunction and death has broadened understanding of how Parkinson’s disease develops and introduced a valuable tool for tracking its progress.

Physicians at Rush have demonstrated that the alpha-synuclein protein can also be seen in the nerve cells in the wall of the intestines in research subjects with early Parkinson’s disease, but not in healthy subjects. In this study, 10 subjects with early Parkinson’s disease had flexible sigmoidoscopy, a technique like colonoscopy, in which a flexible scope is inserted into the lower intestine. In the flexible sigmoidoscopy technique, the scope is only inserted about 8 inches and no colon preparation or anesthesia are required. The procedure takes only 5-10 minutes.

Now, a group of Rush scientists has become the first to demonstrate alpha-synuclein aggregation in biological tissue obtained before onset of motor symptoms of Parkinson’s disease.

The studies, published the May 15 issue of the journal Movement Disorders, were conducted by Dr. Kathleen M. Shannon, neurologist in the Movement Disorders and Parkinson’s Center at Rush, and a multidisciplinary team of scientists at Rush. The team analyzed samples of tissue obtained during colonscopy examinations that took place 2-5 years before the first symptom of Parkinson’s disease appeared in 3 research subjects, and all 3 showed the characteristic protein in the wall of the lower intestine.

“Recent clinical and pathological evidence supports the notion that Parkinson’s disease may begin in the intestinal wall then spread through the nerves to the brain. Clinical signs of intestinal disease, such as constipation, Parkinson’s disease diagnosis by more than a decade. These studies suggest it may one day be possible to use colonic tissue biopsy to predict who will develop motor Parkinson’s disease,” said Shannon.

“Such tissue could be obtained at the time of screening colonoscopy, a procedure routinely applied for colon cancer surveillance beginning at age 50, and repeated every three to 10 years in adults of middle age,” said Shannon.

Alternatively, the Rush investigators showed that colonic tissue is easily obtained using flexible sigmoidoscopy, a technique that, unlike colonoscopy, requires no colon cleansing preparation or sedation, and can be performed in 10 minutes.

Currently, diagnosis of Parkinson’s disease depends on the appearance of such cardinal features as tremor, slowed movement, rigidity and gait problems. The clinical diagnosis can be difficult early in the disease, and as many as 10 percent to 20 percent of patients may be misdiagnosed. Studies have shown that by the time primary symptoms appear, many patients with Parkinson’s disease will have lost 60 percent to 80 percent or more of dopamine-producing cells in the brain.

“In view of a multi-billion-dollar translational research effort that aims to identify agents that slow or stop the progression of Parkinson’s disease, the need for accurate and timely diagnostic biomarkers, including the potential for pre-motor diagnosis, is particularly acute,” the authors stated.

“We believe that alpha-synuclein in the colonic submucosa may be a pre-motor biomarker that easily can be studied in cohorts at increased risk of developing Parkinson’s disease (relatives of Parkinson’s disease subjects, subjects with anosmia [inability to smell], rapid eye movement sleep behavior disorder and others).”

The Rush scientists stressed the need to replicate this finding in other populations, including normal controls as well as in subjects with other neurodegenerative Parkinson’s-like disorders, and to determine the safest and highest-yield biomarker site.

Roughly 60,000 people in the United States are diagnosed with Parkinson’s disease each year, according to the Parkinson’s Disease Foundation. In all, more than 1.5 million people in the United States suffer from the condition. Yet thousands of cases go undetected and diagnosing the disease in the early stages remains challenging.

Early diagnosis of Parkinson’s enables the disease to be treated with drugs such as dopamine agonists and monoamine oxidase type-B inhibitors, which can alleviate the condition’s symptoms and postpone the need to begin levodopa therapy. Nevertheless, early diagnosis of Parkinson’s has remained challenging and misdiagnoses are common.

Two recent studies performed at Rush University Medical Center (Chicago) point to an alternate way of diagnosing the disease: colonic tissue obtained during colonoscopy or flexible sigmoidoscopy might be used to predict who will develop the disease.

From the abstract published in the Movement Disorders journal:

Despite clinicopathological evidence that Parkinson’s disease (PD) may begin in peripheral tissues, identification of premotor Parkinson’s disease is not yet possible. Alpha-synuclein aggregation underlies Parkinson’s disease pathology, and its presence in peripheral tissues may be a reliable disease biomarker. Objective: We sought evidence of alpha-synuclein pathology in colonic tissues before the development of characteristic Parkinson’s disease motor symptoms. Methods: Old colon biopsy samples were available for three subjects with PD. Biopsies were obtained 2-5 years before PD onset. We performed immunohistochemistry studies for the presence of alpha-synuclein and Substance P in these samples. Results: All subjects showed immunostaining for alpha-synuclein (two, five and two years before first motor Parkinson’s disease symptom). No similar alpha-synuclein immunostaining was seen in 23 healthy controls. Staining of samples for substance P suggested colocalization of alpha-synuclein and substance P in perikarya and neurites. Conclusions: This is the first demonstration of alpha-synuclein in colon tissue prior to onset of PD. Additional study is required to determine whether colonic mucosal biopsy may be a biomarker of premotor PD

The scientists examined the tissue samples of people who later developed Parkinson’s disease. The samples were taken several years before the patients showed symptoms of the neurological disorder.

Kathleen M. Shannon, neurologist in the Movement Disorders and Parkinson’s Center at Rush, who was involved in the study, offered the following thought-provoking quote in a statement (emphasis added):

“Recent clinical and pathological evidence supports the notion that Parkinson’s disease may begin in the intestinal wall then spread through the nerves to the brain. Clinical signs of intestinal disease, such as constipation, [may precede] Parkinson’s disease diagnosis by more than a decade. These studies suggest it may one day be possible to use colonic tissue biopsy to predict who will develop motor Parkinson’s disease.”

While the research might ultimately lead to the use of colonoscopy or flexible sigmoidoscopy to diagnose Parkinson’s, the researchers stress the need for more studies to replicate the findings in larger patient populations with Parkinson’s and Parkinson’s-like disorders.

Source : http://www.sciencecodex.com/colonoscopy_or_flexible_sigmoidoscopy_may_be_used_to_predict_parkinsons-91559

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Nidek AFC-330 Automated Fundus Camera Cleared in U.S.

Nidek AFC-330 Automated Fundus Camera Cleared in U.S.

Nidek AFC-330 Automated Fundus Camera Cleared in U.S.

FREMONT, Calif. and JACKSONVILLE, Fla., May 15, 2012 (GLOBE NEWSWIRE) — NIDEK, a global leader in the design, manufacturing, and distribution of ophthalmic equipment, announces the FDA 510(k) Clearance for the AFC-330, their most automated fundus camera yet.

A photo accompanying this release is available at http://www.globenewswire.com/newsroom/prs/?pkgid=12900

“The AFC-330 represents NIDEK’s 3rd generation of automated fundus camera. We are both proud and excited to be leading the way designing and producing fundus cameras that are faster, easier, and more versatile than ever. We anticipate increasing our fundus camera market share with our market expansion with MARCO Ophthalmic.”

Motoki Ozawa, President and CEO of NIDEK

“We couldn’t be more excited about adding the Nidek AFC-330 automated fundus camera to our full product line of diagnostic technologies. The AFC-330 fits perfectly into Marco’s successful model of increasing efficiency with the kind of powerful, easy-to-use, and high-quality instrumentation that our customers have come to expect.”

David Marco, President and CEO of MARCO

The AFC-330 makes quantum leaps improving the operator and patient interface, simplicity, automation, and total practice efficiencies. This camera offers an all in one compact design, auto alignment on the X-Y-Z axis, and a wide range of automated features including auto stereo for Glaucoma Management. The lower flash intensity and sound-dampening internal movements mean less retakes and improved patient comfort. No other Non-Mydriatic camera provides both this level of advanced automation and image quality.

While NIDEK will continue to sell to the Ophthalmology market in the United States, MARCO, the leader in Vision Diagnostics, will sell the NIDEK AFC-330 to the Optometry market. This market expansion is to increase the distribution channels and better serve new and existing customers for both companies.

About NIDEK:

Founded in Gamagori, Japan in 1971, NIDEK continues to be a global leader in research and development, design, manufacture and distribution of ophthalmic equipment. The United States subsidiary based in Silicon Valley, California, provides sales and service for ophthalmic lasers, refractive lasers, and many advanced diagnostic devices.

The Nidek Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=1006

About MARCO:

Founded in Jacksonville, FL, in 1967, MARCO continues to expand its position as ‘The Leader in Vision Diagnostics’ with a product line that encompasses classical lane equipment and NIDEK high-tech, automated refractive and retinal instrumentation. MARCO continues to provide unparalleled training and support to its expanding United States customer base.

Features

All in one with built-in camera and computer

Five automated functions for enhanced ease-of-use

Monitor and indicator for operator assist

Navigation of stereo and panorama photography

Low flash intensity and quiet shutter sound

NIDEK (Gamagori, Japan) has received FDA clearance to market its AFC-330 fundus camera in the U.S. The unit is an all-in-one system that contains both the camera and the processing computer, negating the need for another machine to remain nearby.

The device is the company’s most automated model, and features automatic alignment along the three axis, uses a lower brightness flash, and has dampened mechanical components, among other advances.

More details about the AFC-330 from the product page:

All in one with built-in camera and computer

The AFC-330 has an integrated CCD camera and microcomputer in one compact unit without requiring an external camera and PC. It is virtually “ready to use out of the box”.

Five automated functions for enhanced ease-of-use

With five automated functions – 3-D auto tracking, auto focus, auto switching from anterior eye to fundus, auto shot, and auto print / export – the AFC-330 enables seamless photography from start to finish.

Monitor and indicator for operator assist

The anterior eye monitor allows an operator to constantly verify alignment. The focus split indicator shows the amount of focus deviation in the fundus observation screen.

Navigation of stereo and panorama photography

The AFC-330 navigates stereo and panorama photography with target marks displayed on observation screen.

Low flash intensity and quiet shutter sound

The AFC-330 reduces flash intensity by 40% and sound of the shutter by 50% compared to its predecessor, the AFC-230 / 210.

Source : http://www.globenewswire.com/newsroom/news.html?d=256233

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Angel Catheter Combines Central Venous Catheter with IVC Filter for Pulmonary Embolism Prevention

Angel Catheter Combines Central Venous Catheter with IVC Filter for Pulmonary Embolism Prevention

Angel Catheter Combines Central Venous Catheter with IVC Filter for Pulmonary Embolism Prevention

SAN ANTONIO, May 15, 2012 /PRNewswire/ — BiO2 Medical, Inc. a Texas based medical device manufacturer with corporate offices in San Antonio, Texas, and R&D and manufacturing operations in Golden, Colorado, announced today that it has received CE Mark approval for the Angel™ Catheter, a Nitinol Inferior Vena Cava (IVC) filter, permanently attached to a central venous catheter (CVC) for the use of preventing Pulmonary Embolism (PE) in critically ill patients. This novel IVC filter/CVC combination device is the first IVC filter with a prophylactic use indication, and allows attending physicians the ability to place an IVC filter bedside in the Intensive Care Unit (ICU), in a procedure resembling a routine CVC placement procedure.

According to Luis F. Angel, MD, BiO2 Medical’s Chief Medical Officer and inventor of the Angel™ Catheter, “Obtaining the CE clearance for commercialization of the Angel™ Catheter in Europe is a significant step in our goal to provide an alternative for critically ill patients at high risk of Pulmonary Embolism (PE). It also validates a long and complex process of extensive testing for the use of our device as a prophylaxis against PE.”

“With CE Mark approval for the Angel™ Catheter, and preliminary safety data from a First in Man clinical study, these are exciting times for the entire team at BiO2 Medical. We’ve been working diligently over the past several years to bring this product to market, and I am justifiably impressed and proud of everyone who has helped to bring this life saving device to market,” stated Christopher E. Banas, BiO2 Medical’s Chairman and Chief Executive Officer.

The AngelTM Catheter is a truly retrievable IVC filter that is permanently attached to a multi-lumen central venous access catheter. It is intended for use in critically ill patients with VTE disease who are at increased risk of PE but for whom anticoagulation therapy is temporarily contraindicated.

The design of the Angel™ Catheter allows for easy insertion and access to the central venous system for administering medications, fluids, or blood products; blood sampling; and monitoring of central venous pressure.

The Angel™ Catheter is intended to be used during the critical time period in which anticoagulation therapy poses a high risk of complications, including major bleeding and death, and in which patients are at highest risk of VTE. The filter can be easily removed when the central line is removed, once the danger of VTE has been resolved.

The Angel™ Catheter was invented by Luis F. Angel, MD, at the University of Texas Health Science Center at San Antonio, in response to the crucial problem of PE in critically ill patients. This device takes advantage of a commonly used medical procedure, the placement of a central line, and allows for the placement of a truly temporary IVC filter as a means of PE prophylaxis in critically ill patients. These patients are at the highest risk for complications with anticoagulation therapy and are frequently too sick to be moved outside the ICU for placement of an IVC filter. Therefore, the Angel™ Catheter will allow for substantially improved PE prophylaxis and the potential for a worldwide reduction in the rates of PE-related mortality and morbidity.

BiO2 Medical has been working with Rosenbaum & Silvert, P.C., an intellectual property firm, to vigorously pursue and obtain patent protection for BiO2 Medical’s entire technology portfolio, including the designs and concepts of the Angel™ Catheter.

BiO2 Medical has received CE Mark approval for the Angel Catheter, a nitinol inferior vena cava (IVC) filter permanently attached to a central venous catheter, for the use of preventing pulmonary embolism in critically ill patients. The multi-lumen catheter can be used like a normal central venous system for administering medications, fluids or blood products, blood sampling and monitoring of central venous pressure. At the same time it provides pulmonary embolism prophylaxis by means of the attached IVC filter.

The primary patient population is critical care patients in whom anticoagulation therapy poses a high risk of complications, including major bleeding and death, and in which patients are at highest risk of venous thromboembolism (VTE). The filter can be easily removed when the central line is removed, once the danger of VTE has been resolved.

The combined central line/IVC filter makes placement easy as insertion is a bedside procedure not very different from normal central line placement and guarantees the filter is truly temporary as it slides out along with central line removal. Moreover, the design eliminates some of the potential complications of traditional IVC’s: vena cava perforation caused by hooks, filter tilting, filter migration, and irretrievability.

Source : http://www.bio2medical.com/angel-catheter/

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St Jude Medical Launches EnligHTN Renal Denervation System

St Jude Medical Launches EnligHTN Renal Denervation System

St Jude Medical Launches EnligHTN Renal Denervation System

St. Jude Medical Announces European Approval and Launch of the EnligHTN Renal Denervation System for Treatment of Hypertension

Decades of experience in ablation technologies used to develop the industry’s first multi-electrode technology for renal denervation

ST. PAUL, Minn. & PARIS–(BUSINESS WIRE)–May. 15, 2012– St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced CE Mark Approval and launch of its EnligHTN™ renal denervation system during EuroPCR. Renal denervation is a specialized ablation procedure that has been clinically proven to reduce blood pressure in patients with hypertension, or high blood pressure, that is resistant to medical therapy. Clinical data from the EnligHTN I trial about the safety and efficacy of the company’s renal denervation technology will be presented on Wednesday.

Hypertension is a root cause of a variety of life-threatening health problems, including heart disease, stroke, and kidney failure. It impacts more than 1 billion people globally at an estimated cost of $500 billion annually. About 25 percent of patients with hypertension do not respond adequately to conventional treatment with medication.

“In my experience, the EnligHTN renal denervation system has been successful in reducing blood pressure in patients with resistant hypertension,” said Prof. Stephen Worthley, the EnligHTN I trial’s Primary Investigator from Royal Adelaide Hospital in Australia. “The multi-electrode renal denervation system provides an efficient and effective alternative treatment for patients with resistant hypertension, and has the possibility to change the way that hypertension is treated.”

Using the EnligHTN system, an ablation catheter delivers radiofrequency (RF) energy to create lesions (tiny scars) along the renal sympathetic nerves – a network of nerves that help to regulate pressure; the intentional disruption of the nerve supply has been clinically found to decrease systolic blood pressure. This is important because the risk of cardiovascular death is cut in half with every 20 point decrease in systolic blood pressure.

“St. Jude Medical is focused on improving patient care while reducing the economic burden of epidemic diseases, and our groundbreaking EnligHTN renal denervation system is a great example of that focus,” said Frank Callaghan, president of the St. Jude Medical Cardiovascular Division. “This launch is important because it represents a significant growth opportunity and exemplifies our commitment to advancing the practice of medicine. We’ve applied the decades of insight we’ve gained from developing successful ablation technologies that treat cardiac arrhythmias to establish an innovative solution for hypertension.”

The system is the industry’s first multi-electrode ablation technology for renal denervation. With the unique basket design, each placement of the ablation catheter allows a consistent and predictable pattern of four ablations in 90-second intervals. Compared to single electrode ablations, the multi-electrode EnligHTN system has the potential to improve consistency and procedural reliability, save time as well as result in workflow and cost efficiencies. Additionally, the minimal catheter repositioning may result in a reduction of contrast and fluoroscopic (x-ray) exposure.

The technology includes a guiding catheter, ablation catheter and ablation generator. The generator uses a proprietary, temperature-controlled algorithm to deliver effective therapy.

Renal Denervation at EuroPCR

Data from the EnligHTN I (ARSENAL) trial, a prospective, multi-center study for the St. Jude Medical EnligHTN renal denervation system, will be presented during the session Novel Approaches to Renal Denervation: Preclinical and First-In-Man Studies on Wednesday, May 16 at 8:00 in room 242A. The study, led by Prof. Worthley, is expected to demonstrate the safety and efficacy of the system in the treatment of patients with treatment-resistant hypertension.

A St. Jude Medical-sponsored tools and techniques session about renal denervation entitled A Practical Guide to EnligHTN Renal Denervation: a New Approach for the Treatment of Resistant Hypertension will take place Wednesday, May 16 beginning at 12:00 in Room Maillot. The session will include lectures on a variety of topics, including the role the renal nerves play in hypertension maintenance and how to set up a renal denervation practice as well as a pre-recorded live demonstration.

Attendees can visit St. Jude Medical at booth F8 and F9 found on Level 1 of the exhibition hall during EuroPCR to see the EnligHTN renal denervation system or visit SJMenligHTN.com.

About St. Jude Medical

St. Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. St. Jude Medical is headquartered in St. Paul, Minn. and has four major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. For more information, please visit sjm.com.

Forward-Looking Statements

This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. Such forward-looking statements include the expectations, plans and prospects for the Company, including potential clinical successes, anticipated regulatory approvals and future product launches, and projected revenues, margins, earnings and market shares. The statements made by the Company are based upon management’s current expectations and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include market conditions and other factors beyond the Company’s control and the risk factors and other cautionary statements described in the Company’s filings with the SEC, including those described in the Risk Factors and Cautionary Statements sections of the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2011 and Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2012. The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.

A Breakthrough Technology on Many Points

The EnligHTN™ multi-electrode renal denervation system enables cutting-edge efficiencies in procedural-based hypertension control by reducing the number of catheter manipulations needed to disrupt the sympathetic nerve network — with speed and placement accuracy.1-3 Renal denervation has been demonstrated to effectively reduce systolic blood pressure.4

Fast

EnligHTN administers a predictable pattern of four ablations with each placement — in 90-second intervals — potentially reducing renal denervation procedure time.2,3

Efficient

Unique multi-ablation basket design provides four ablations without readjustment.

Precise

Consistent, four-point contact with arterial wall designed to increase procedural accuracy.

Minimized Exposure

Minimal catheter repositioning may result in shorter procedure time, reduced contrast and fluoroscopic exposure.*

Your Partner in Renal Denervation Treatment

The EnligHTN renal denervation system offers advanced renal artery ablation therapy and is designed to deliver radiofrequency (RF) energy to the renal nerves to achieve targeted denervation. The core system components are the EnligHTN™ RF ablation generator, the EnligHTN™ renal artery ablation catheter and the EnligHTN™ guiding catheter.

It seems that renal denervation systems are popping up like daisies these days. Today at the EuroPCR meeting in Paris, France, St. Jude Medical announced CE Mark Approval and the launch of its EnligHTN renal denervation system. Like other renal ablative systems, this one is approved to reduce blood pressure in patients with hypertension resistant to medical therapy.

Similar to the Vessix Vascular V2 system, the EnligHTN has multiple electrodes which potentially saves time during the ablation procedure, as four ablations can be performed without catheter repositioning.

From the press release:

Using the EnligHTN system, an ablation catheter delivers radiofrequency (RF) energy to create lesions (tiny scars) along the renal sympathetic nerves – a network of nerves that help to regulate pressure; the intentional disruption of the nerve supply has been clinically found to decrease systolic blood pressure. This is important because the risk of cardiovascular death is cut in half with every 20 point decrease in systolic blood pressure.

The system is the industry’s first multi-electrode ablation technology for renal denervation. With the unique basket design, each placement of the ablation catheter allows a consistent and predictable pattern of four ablations in 90-second intervals. Compared to single electrode ablations, the multi-electrode EnligHTN system has the potential to improve consistency and procedural reliability, save time as well as result in workflow and cost efficiencies. Additionally, the minimal catheter repositioning may result in a reduction of contrast and fluoroscopic (x-ray) exposure.

The technology includes a guiding catheter, ablation catheter and ablation generator. The generator uses a proprietary, temperature-controlled algorithm to deliver effective therapy.

St. Jude Medical will be presenting clinical data from the EnligHTN I trial about the safety and efficacy of the system at EuroPCR on Wednesday.

Update: This story previously stated incorrectly that the EnligHTN is uniquely the only approved renal denervation system with multiple electrodes.

Source : http://investors.sjm.com/phoenix.zhtml?c=73836&p=irol-newsArticle&ID=1695802

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Infra-Red Retinal Prosthesis Restores Sight From an Ultra-Thin Package

Infra-Red Retinal Prosthesis Restores Sight From an Ultra-Thin Package

Infra-Red Retinal Prosthesis Restores Sight From an Ultra-Thin Package

This pinpoint-sized photovoltaic chip (upper right corner) is implanted under the retina in a blind rat to restore sight. The center image shows how the chip is comprised of an array of photodiodes, which can be activated by pulsed near-infrared light to stimulate neural signals in the eye that propagate then to the brain. A higher magnification view [lower left corner] shows a single pixel of the implant, which has three diodes around the perimeter and an electrode in the center. The diodes turn light into an electric current which flows from the chip into the inner layer of retinal cells

Using tiny solar-panel-like cells surgically placed underneath the retina, scientists at the Stanford University School of Medicine have devised a system that may someday restore sight to people who have lost vision because of certain types of degenerative eye diseases.

This device — a new type of retinal prosthesis — involves a specially designed pair of goggles, which are equipped with a miniature camera and a pocket PC that is designed to process the visual data stream. The resulting images would be displayed on a liquid crystal microdisplay embedded in the goggles, similar to what’s used in video goggles for gaming. Unlike the regular video goggles, though, the images would be beamed from the LCD using laser pulses of near-infrared light to a photovoltaic silicon chip — one-third as thin as a strand of hair — implanted beneath the retina.

Electric currents from the photodiodes on the chip would then trigger signals in the retina, which then flow to the brain, enabling a patient to regain vision.

A study, published online May 13 in Nature Photonics, shows how scientists used rat retinas to assess the photodiode arrays in vitro, and how the diodes produced electric responses that are widely accepted indicators of visual activity. The scientists are now testing the system in live rats, taking both physiological and behavioral measurements, and are hoping to find a sponsor to support tests in humans.

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» Laser system developed at Stanford shows promise for cataract surgery

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“It works like the solar panels on your roof, converting light into electric current,” said Daniel Palanker, PhD, associate professor of ophthalmology and the paper’s senior author. “But instead of the current flowing to your refrigerator, it flows into your retina.” Palanker is also a member of the Hansen Experimental Physics Laboratory at Stanford and of the interdisciplinary Stanford research program, Bio-X. The study’s co-first authors are Keith Mathieson, PhD, a visiting scholar in Palanker’s lab, and James Loudin, PhD, a postdoctoral scholar. Palanker and Loudin jointly conceived and designed the prosthesis system and the photovoltaic arrays.

There are several other retinal prostheses being developed, and at least two of them are in clinical trials. A device made by the Los Angeles-based company Second Sight was approved in April for use in Europe, and another prosthesis-maker, a German company called Retina Implant AG, announced earlier this month results from its clinical testing in Europe.

Unlike these other devices — which require coils, cables or antennas inside the eye to deliver power and information to the retinal implant — the Stanford device uses near-infrared light to transmit images, thereby avoiding any need for wires and cables, and making the device thin and easily implantable.

“The current implants are very bulky, and the surgery to place the intraocular wiring for receiving, processing and power is difficult,” Palanker said. The device developed by his team, he noted, has virtually all of the hardware incorporated externally into the goggles. “The surgeon needs only to create a small pocket beneath the retina and then slip the photovoltaic cells inside it.” What’s more, one can tile these photovoltaic cells in larger numbers inside the eye to provide a wider field of view than the other systems can offer, he added.

Daniel Palanker

Stanford University holds patents on two technologies used in the system, and Palanker and colleagues would receive royalties from the licensing of these patents.

The proposed prosthesis is intended to help people suffering from retinal degenerative diseases, such as age-related macular degeneration and retinitis pigmentosa. The former is the foremost cause of vision loss in North America, and the latter causes an estimated 1.5 million people worldwide to lose sight, according to the nonprofit group Foundation Fighting Blindness. In these diseases, the retina’s photoreceptor cells slowly degenerate, ultimately leading to blindness. But the inner retinal neurons that normally transmit signals from the photoreceptors to the brain are largely unscathed. Retinal prostheses are based on the idea that there are other ways to stimulate those neurons.

The Stanford device uses near-infrared light, which has longer wavelength than normal visible light. It’s necessary to use such an approach because people blinded by retinal degenerative diseases still have photoreceptor cells, which continue to be sensitive to visible light. “To make this work, we have to deliver a lot more light than normal vision would require,” said Palanker. “And if we used visible light, it would be painfully bright.” Near-infrared light isn’t visible to the naked eye, though it is “visible” to the diodes that are implanted as part of this prosthetic system, he said.

Palanker explained what he’s done by comparing the eye to camera, in which the retina is the film or the digital chip, and each photoreceptor is a pixel. “In our model we replace those photoreceptors with photosensitive diodes,” he said. “Every pixel is like a little solar cell; you send light, then you get current and that current stimulates neurons in the inner nuclear layer of the retina.” That, in turn, should have a cascade effect, activating the ganglion cells on the outer layer of the retina, which send the visual information to the brain that allows us to see.

For this study, Palanker and his team fabricated a chip about the size of a pencil point that contains hundreds of these light-sensitive diodes. To test how these chips responded, the researchers used retinas from both normal rats and blind rats that serve as models of retinal degenerative disease. The scientists placed an array of photodiodes beneath the retinas and placed a multi-electrode array above the layer of ganglion cells to gauge their activity. The scientists then sent pulses of light, both normal and near-infrared, to produce electric current in the photodiodes and measured the response in the outer layer of the retinas.

In the normal rats, the ganglions were stimulated, as expected, by the normal visible light, but they also presented a similar response to the near-infrared light: That’s confirmation that the diodes were triggering neural activity.

In the degenerative rat retinas, the normal light elicited little response, but the near-infrared light prompted strong spikes in activity roughly similar to what occurred in the normal rat retinas. “They didn’t respond to normal light, but they did to infrared,” said Palanker. “This way the sight is restored with our system.” He noted that the degenerated rat retinas required greater amounts of near-infrared light to achieve the same level of activity as the normal rat retinas.

While there was concern that exposure to such doses of near-infrared light could cause the tissue to heat up, the study found that the irradiation was still one-hundredth of the established ocular safety limit.

Since completing the study, Palanker and his colleagues have implanted the photodiodes in rats’ eyes and been observing and measuring their effect for the last six months. He said preliminary data indicates that the visual signals are reaching the brain in normal and in blind rats, though the study is still under way.

While this and other devices could help people to regain some sight, the current technologies do not allow people to see color, and the resulting vision is far from normal, Palanker said.

Other members of Palanker’s lab involved in the research are graduate students Georges Goetz, David Boinagrov and Lele Wang; senior research associate Philip Huie; research associates Ludwig Galambos and Susanne Pangratz-Fuehrer, PhD; and postdoctoral scholars Yossi Mandel, MD, PhD, and Daniel Lavinsky, MD, PhD. In addition, Theodore Kamins, PhD, a consulting professor in electrical engineering, and James Harris, PhD, professor in the School of Engineering, are co-authors. The team also collaborated with scientists at the Santa Cruz Institute for Particle Physics at UC-Santa Cruz.

Funding was provided by the National Institutes of Health, the Air Force Office of Scientific Research and Stanford’s Bio-X program. Information about Stanford’s Department of Ophthalmology, which also supported the research, is available at http://ophthalmology.stanford.edu/.

Retinal degenerative diseases lead to blindness due to loss of the ‘image capturing’ photoreceptors, while neurons in the ‘image-processing’ inner retinal layers are relatively well preserved. Electronic retinal prostheses seek to restore sight by electrically stimulating the surviving neurons. Most implants are powered through inductive coils, requiring complex surgical methods to implant the coil-decoder-cable-array systems that deliver energy to stimulating electrodes via intraocular cables. We present a photovoltaic subretinal prosthesis, in which silicon photodiodes in each pixel receive power and data directly through pulsed near-infrared illumination and electrically stimulate neurons. Stimulation is produced in normal and degenerate rat retinas, with pulse durations of 0.5–4 ms, and threshold peak irradiances of 0.2–10 mW mm-2, two orders of magnitude below the ocular safety limit. Neural responses were elicited by illuminating a single 70 µm bipolar pixel, demonstrating the possibility of a fully integrated photovoltaic retinal prosthesis with high pixel density.

Scientists at the Stanford University School of Medicine are developing a new type of retinal prosthesis which aims to simplify the complex surgery associated with existing, bulkier implants. The prosthetic comprises a pair of goggles and an implanted retinal sensor made up of an array of light-sensitive photodiodes.

The goggles incorporate a miniature camera, a pocket computer for processing the camera data, and an LCD screen embedded into the goggles for displaying the data. The LCD screen beams images using laser pulses of near-infrared light to a photovoltaic ultra thin silicon chip implanted beneath the retina. The chip, in turn, translates the infra-red pulses to neural pulses in the retina which can be processed as images in the brain. The key selling point for the new implant is the elimination of wires and cables and the relative simplicity of implantation.

In order to test the retinal implant, the research team implanted the array of photodiodes in the retinas of normal and blind rats. They then compared the ganglion activity of both groups in response to visible light and the infra-red light pulses generated by the goggles, as explained in the press release:

For this study, Palanker [Prof. Daniel Palanker, the senior investigator involved in the study] and his team fabricated a chip about the size of a pencil point that contains hundreds of these light-sensitive diodes. To test how these chips responded, the researchers used retinas from both normal rats and blind rats that serve as models of retinal degenerative disease. The scientists placed an array of photodiodes beneath the retinas and placed a multi-electrode array above the layer of ganglion cells to gauge their activity. The scientists then sent pulses of light, both normal and near-infrared, to produce electric current in the photodiodes and measured the response in the outer layer of the retinas.

In the normal rats, the ganglions were stimulated, as expected, by the normal visible light, but they also presented a similar response to the near-infrared light: That’s confirmation that the diodes were triggering neural activity.

In the degenerative rat retinas, the normal light elicited little response, but the near-infrared light prompted strong spikes in activity roughly similar to what occurred in the normal rat retinas.

The results from this study have been published online in the journal Nature Photonics. The team is currently undertaking a longitudinal study on the efficacy of the implant over a number of months in rat models.

source : http://med.stanford.edu/ism/2012/may/retina.html

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