Author Archive

Page 1 of 1612345...10...Last »

Towards high-speed imaging of infrared photons with bio-inspired nanoarchitectures

Towards high-speed imaging of infrared photons with bio-inspired nanoarchitectures

Scientists at the research arm of General Electric have developed a heat sensor that consists of wings of the Morpho butterfly coated with single-walled carbon nanotubes. The device detects mid-wave infrared light with a precision of less than 0.06° C at a rate of about 40 Hz. GE believes the technology can be used in future medical imaging devices for visualizing inflammation and for thermal characterization of wounds.GE-butterfly-heat-sensor

Here’s more from Radislav Potyrailo, the lead scientist of the study:

Starting from our initial experiments in early 2008 and followed by more detailed studies over 2009 – 2010, we have found that scales of Morpho butterfly wings can serve as low thermal mass optical resonators and rapidly respond to temperature changes with very high sensitivity.

Our team has found that in these resonators, the optical cavity is modulated by its thermal expansion and refractive index change, resulting in conversion of infrared heat into visible iridescence changes. We further decorated the Morpho butterfly scales with single-walled carbon nanotubes and achieved heat detection with the temperature resolution of 0.02 – 0.06oC and 35 – 40 Hz response rate without the need to use a heat sink for heat removal. In the thermographic image below you can see me first holding and then breathing onto a Morpho butterfly.

The nanoscale pitch and the extremely small thermal mass of individual “pixels” of this Morphobutterfly nanostructure promise significant improvements compared to existing detectors in the cost of detectors, response speed, temperature resolution, the ability to obtain more crisp thermal images, and to have thermal images from different infrared spectral regions – all these factors being critical for the much broader acceptance of thermal imaging technologies in consumer electronic products.

Existing infrared detectors rely on complex microfabrication and thermal management methods. Here, we report an attractive platform of low-thermal-mass resonators inspired by the architectures of iridescent Morpho butterfly scales. In these resonators, the optical cavity is modulated by its thermal expansion and refractive index change, resulting in ‘wavelength conversion’ of mid-wave infrared (3–8 µm) radiation into visible iridescence changes. By doping Morpho butterfly scales with single-walled carbon nanotubes, we achieved mid-wave infrared detection with 18–62 mK noise-equivalent temperature difference and 35–40 Hz heat-sink-free response speed. The nanoscale pitch and the extremely small thermal mass of individual ‘pixels’ promise significant improvements over existing detectors. Computational analysis explains the origin of this thermal response and guides future conceptually new bio-inspired thermal imaging sensor designs.

Source:http://www.nature.com/nphoton/journal/vaop/ncurrent/full/nphoton.2011.355.html

Full story

British MHRA approves pancreas trial

British MHRA approves pancreas trial

SpectraCure AB, a Swedish medical device company, has received approval to begin testing the Interstitial PhotoDynamic Therapy (IPDT) system on pancreatic cancer patients in the UK. Photodynamic therapy comprises a light-activated drug and a matching light source. SpectraCure-AB-device-The light-activated drug is administered to the patient prior to surgery and absorbed by the tumor. When light is delivered to the region of the tumor, it activates the light sensitive drug which destroys the cancerous tumor cells through apoptosis or necrosis.

Photodynamic therapy has been around for some time, but is frequently limited in its use to deeper lying tumors due to the poor penetration depth of the light source and difficulties in controlling the dose. SpectraCure’s IPDT system aims to overcome these problems by delivering the laser light source through fiber optic cables which also monitor the dose by feeding back optical data from the treated region.

To date, tests on prostate cancer patients in Sweden have shown that the method works for internal tumors, and in the Spring a clinical study on recurrent prostate cancer will begin in the US and Canada pending approvals.SpectraCure has applied to the British Medicines and Healthcare products Regulatory Agency (MHRA) to co-sponsor a clinical study on pancreatic cancer in the UK. On the February 15th MHRA approved the notification.

Full story

’ NNew NNew Biograph mCT ewew Biograph mCT PET PET••CT System ••CT System Receives FDA Clearance

’ NNew NNew Biograph mCT ewew Biograph mCT PET PET••CT System  ••CT System Receives FDA Clearance

Siemens‘ Biograph mCT, a positron emission tomography-computed tomography (PET-CT) scanner which was introduced at the annual meeting of the Radiological Society of North America (RSNA) in Chicago a few months ago, has now received FDA 510k clearance.Siemens-Biograph-mCT-scan-full-body

The Biograph mCT enables the quantification of molecular processes in the body. Current applications include cancer imaging, quantification of absolute myocardial blood flow and quantification of amyloid deposits in the brain in patients with dementia.

Some of the highlights of the new system, from the press release:

With conventional technology, clinicians face the issue of variability in quantitative results due to software and hardware challenges. Engineered to overcome these technical and procedural obstacles, the new Biograph mCT offers accurate and reproducible quantificat ion in PET•CT imaging by ensuring optimization of each element of the imaging chain – with an emphasis on the finest volumetric image resolution on the market, daily system calibration, accuracy of attenuation correction using automated co-registration algorithms, and more automated, user-independent and reproducible standardized uptake value (SUV) calculation methods for daily clinical practice.

The new Biograph mCT incorporates Siemens’ unique OptisoHD (High-Definition) Detector System, which features a fine volumetric resolution of only 87 mm. Other innovative technologies include Time of Flight (TOF) and HD•PET, ensuring fast, precise images with minimum radiation dose. With Siemens Quanti•QC, daily system normalization can be performed overnight, calibrating and tuning the system to precisely the right specifications, facilitating consistent and optimal performance, day after day.

Siemens Molecular & Anatomical Registration Technologies (SMART) address the traditional problems of inherent scanner drift and inaccurate attenuation correction through misregistration of anatomical and functional images. To facilitate accurate attenuation correction and reliable quantitative measurements, the new Biograph mCT’s unique patient handling system virtually eliminates differential deflection. The system also features Auto Cardiac Registration that automatically aligns CT and PET heart images and reduces variability between users. Additionally, SMART offers a new form of attenuation correction for neurological images that no longer requires CT data.

Advanced syngo clinical applications provide essential tools to obtain quantifiable measurements in neurology, cardiology and oncology imaging. SUVpeak, new in the syngo.via oncology engine, provides consistent, reproducible quantitative assessments of hot spots. Myocardial blood flow (MBF) can be used as an absolute quantification method to assess balanced disease in all areas of the heart. Additionally, a new quantitative tool in neurology – the syngo.PET Neuro DB Comparison application as part of the syngo.mCT Neurology engine – automatically registers brain data to a FDG PET normal database to aid in the assessment of neurological disorders.

The new Biograph mCT incorporates the Siemens OptisoHD (High-Definition) Detector System, which will feature a volumetric resolution of 87 mm3. Other technologies include Time of Flight and High-Definition PET, ensuring fast, precise images with minimum radiation dose. This enables precise measurements of metabolic processes including the assessment of neurological disease, cancerous tissue and cardiac blood flow.

Full story

Telcare Unveils New “MyTelcare Diabetes Pal” iPhone App

Telcare Unveils New “MyTelcare Diabetes Pal” iPhone App

Telcare, the maker of the Telcare BGM cellular enabled blood glucose meter, has released an iPhone app that can gather data from the meter even if they’re physically apart.MyTelcare-Diabetes-Pal-

This not only allows you to watch your own glucose, but a parent of a diabetic child can make sure the kid takes regular readings and almost immediately know what the output is.

  • Track from anywhere: This new app combines the power of cellular technology with the newest Apple development tools to synchronize blood glucose, medication and nutrition data from anywhere. With each blood glucose test taken with the Telcare BGM, the app is instantly updated with the newest BG number. For non-Telcare BGM users, the App provides a user-friendly way to update each blood glucose log.
  • Discover trends: With over ten professionally designed graphs and charts, users are able identify trends based on Time of Day, Prescription Adherence, Target Zones, Day of the Week, Standard Deviation, Before and After Meals, Before and After Activity, and more. Users are also able to generate and email a one page, physician-optimized report in approximately 5 seconds. All data can be exported to Microsoft Excel.
  • Share data with others: All data are automatically stored atwww.mytelcare.com, Telcare’s HIPAA-compliant cloud server. Users are able to automatically share their data with health professionals, family members, and others who may be involved in their care. This feature is particularly important to the parents of children with diabetes and to the adult children of elderly people with

“Telcare’s free App is designed to empower every patient by eliminating the hurdles that have made the analysis of glucose readings so time consuming,” said Telcare CEO, Dr. Jonathan Javitt, MD. “We want to increase patients’ understanding of their diabetes and help them and their caregivers properly manage the disease.”

In January, Telcare BGM™ (glucose meter) introduced the industry’s first FDA-cleared, cellular-enabled blood glucose meter. The new MyTelcare Diabetes Pal App allows patients and caregivers to use their iPhone to visualize every glucose reading sent by the Telcare BGM™ while tracking medication, nutrition, activities, and notes. The app also enables patients who don’t have the Telcare BGM to manually enter their blood glucose data and track it over time. Patients and caregivers receive feedback from Telcare’s proprietary rules-based algorithms and the entire Telcare patient community.

While there have been many apps designed to assist people with diabetes in tracking their own results, this is the first to automatically capture data from a blood glucose meter with no extra steps on the part of the patient. This is also the first app designed to share those results with health professionals and family members. A physician sitting at his desk can review the results of all diabetes patients in the practice and the mother sitting at her job can instantly know how her child with diabetes is doing at school.

“The support of endocrinologists and diabetes educators around the world verifies the need for this application,” Dr. Javitt said. “We believe this app’s innovative and intuitive design will help people with diabetes change behavior and as a result improve their health.”

The MyTelcare Diabetes Pal App for iPhone, iPod Touch, and iPad allows people with diabetes and their caregivers to:

  • Track from anywhere: This new app combines the power of cellular technology with the newest Apple development tools to synchronize blood glucose, medication and nutrition data from anywhere. With each blood glucose test taken with the Telcare BGM, the app is instantly updated with the newest BG number. For non-Telcare BGM users, the App provides a user-friendly way to update each blood glucose log.
  • Discover trends: With over ten professionally designed graphs and charts, users are able identify trends based on Time of Day, Prescription Adherence, Target Zones, Day of the Week, Standard Deviation, Before and After Meals, Before and After Activity, and more. Users are also able to generate and email a one page, physician-optimized report in approximately 5 seconds. All data can be exported to Microsoft Excel.
  • Share data with others: All data are automatically stored at www.mytelcare.com, Telcare’s HIPAA-compliant cloud server. Users are able to automatically share their data with health professionals, family members, and others who may be involved in their care. This feature is particularly important to the parents of children with diabetes and to the adult children of elderly people with diabetes.

By utilizing cellular technology rather than Bluetooth or Wi-Fi, devices including Telcare’s glucose meter (Telcare BGM™) and the MyTelcare Diabetes Pal App can communicate with each other without the limitation of having to be physically near one another.

“Recently a severe hypoglycemic episode caused me to be rushed to the hospital,” says Telcare VP Matthew Tendler, who also has Type 1 diabetes. “Although my family was over 500 miles away, they downloaded the MyTelcare App to their iPhones and saw every reading I took, in real-time. My mother’s tears of relief as my diabetes responded to treatment and returned to a stable condition were enough to convince me of the App’s success.”

MyTelcare Diabetes Pal is available for FREE from the App Store at www.itunes.com/appstore or downloaded directly at http://bit.ly/yNeWix. The App is compatible with the iPhone, iPod Touch, and iPad.

About Telcare
Telcare is a leading provider of mHealth solutions that leverage award-winning cellular machine-2-machine technology to bridge the last mile between patients and their caregivers in order to improve the care of chronic illness. Telcare products have been awarded First Place prizes in the categories of Health, Wellness and Fitness Application and Health Enterprise Solution by CTIA and Telcare was just named a finalist in the 2012 Edison Award competition. In addition to directly reducing cost of care by improving outcomes and preventing complications, Telcare creates an ecosystem of care that provides caregivers and disease managers with previously-unavailable actionable clinical data.
Source:http://www.sfgate.com/cgi-bin/article.cgi?f=/g/a/2012/02/14/prweb9193452.DTL

Full story

U.S. FDA Clears Aero DR Wireless 17″ x 17″ Flat Panel Detector

U.S. FDA Clears Aero DR Wireless 17″ x 17″ Flat Panel Detector

Konica Minolta has received FDA clearance to market its Aero DR wireless flat panel radiography detector.  The 17 x 17 inch device weighs about 8 pounds (3.6 Kg).  The device is focused around a Cesium Iodide (CsI) scintillator that promises high detector quantum efficiency (DQE).aero

These detectors also take advantage of Konica Minolta’s very low power circuitry design which decrease read out noise and further raise quantum efficiency. All Aero DR systems deliver high image quality, reliability and easy workflow integration into general radiography environments.

Aero DR systems meet International Standards for both the 14 x 17 and 17 x 17 inch cassette sizes and therefore fit existing wall stands and bucky trays without modifications to help a facility maximize its investment in existing equipment and deliver a universal fit solution. Aero DR systems are offered in many configurations to meet both retrofit and new room purchase scenarios. A new Aero DR portable X-ray upgrade kit solution is also available to efficiently turn portable X-ray systems into digital, wireless solutions.

Wayne, NJ, February 14, 2012 – Konica Minolta announced today that the Aero DR Wireless 17 x 17 inch Flat Panel Detector (FPD) has received U.S. Food and Drug Administration (FDA) clearance. It is the world’s first, wireless 17 x 17 inch FPD weighing only 7.92 lbs.

The increased imaging area of the 17 x 17 inch Aero DR FPD improves clinical workflow and patient care by offering users more versatility in positioning patients and allowing for more clinical data on every exposure, which may decrease the number of exposures needed for studies that require imaging a larger region of interest. Aero DR detectors incorporate Konica Minolta’s own Cesium Iodide (CsI) scintillator that boasts ultra-high detector quantum efficiency (DQE). These detectors also take advantage of Konica Minolta’s very low power circuitry design which decrease read out noise and further raise quantum efficiency. All Aero DR systems deliver high image quality, reliability and easy workflow integration into general radiography environments.

“With the Aero DR, our customers are able to choose between wired and wireless operation. This allows greater flexibility to meet their imaging workflow needs.” says Darren Werner, Digital Products Marketing Manager. “This is the result of Konica Minolta’s dedication to delivering product advancements that contribute to improved patient care.”

Aero DR systems meet International Standards for both the 14 x 17 and 17 x 17 inch cassette sizes and therefore fit existing wall stands and bucky trays without modifications to help a facility maximize its investment in existing equipment and deliver a universal fit solution. Aero DR systems are offered in many configurations to meet both retrofit and new room purchase scenarios. A new Aero DR portable X-ray upgrade kit solution is also available to efficiently turn portable X-ray systems into digital, wireless solutions.

Konica Minolta Medical Imaging

Konica Minolta Medical Imaging is a leading manufacturer/distributor of digital and traditional imaging products for diagnostic use by hospitals, imaging centers, clinics and private practice physicians. Leading products include the REGIUS family of Digital Radiography systems, the Wireless Aero DR Solution, the ImagePilot CR featuring the Sigma Tabletop CR Solution, the DRYPRO family of laser imagers, medical, laser and specialty films and film processing equipment. For more information regarding Konica Minolta products and services, please visit medical.konicaminolta.us.

Source:http://www.konicaminolta.com/medicalusa/news/node_11287

Full story

Researchers make living model of brain tumor

Researchers make living model of brain tumor

Not all cancers are created equal. While some are easy to study in the Petri dish, others don’t do well in vitro. They often will not grow without a supporting framework of angiogenic blood vessels that supply their high metabolism with nutrients and oxygen. Performing experiments on tumors such as glioma is a difficult proposition because they only wish to reside in the body and normally don’t survive when grown outside in a laboratory environment.Glioma

Researchers at Brown University have now managed to grow a three-dimensional glioma tumor, including the supporting proximal blood vessels, and are already using it to perform experiments testing a nanomedicine approach to tumor destruction.

From the announcement:

In a series of experiments, the team showed that iron-oxide nanoparticles ferrying the chemical tumstatin penetrated the blood vessels that sustain the tumor with oxygen and nutrients. The iron-oxide nanoparticles are important, because they are readily taken up by endothelial cells and can be tracked by magnetic resonance imaging.

Previous experiments have shown that tumstatin was effective at blocking endothelial cell growth in gliomas. The tests by the Brown researchers took it to another level by confirming, in a 3-D, living environment, the iron-oxide nanoparticles’ ability to reach blood vessels surrounding a glioma as well as tumstatin’s ability to penetrate endothelial cells.

“The 3-D glioma model that we have developed offers a facile process to test diffusion and penetration into a glioma that is covered by a blood vessel-like coating of endothelial cells,” said Don Ho, a graduate student in the lab of chemistry professor Shouheng Sun and the lead author of the paper in the journal Theranostics. “This assay would save time and money, while reducing tests in living organisms, to examine an agent’s 3-D characteristics such as the ability for targeting and diffusion.”

The tissue model concept comes from Jeffrey Morgan, a bioengineer at Brown and a corresponding author on the paper. Building on that work, Ho and others created an agarose hydrogel mold in which rat RG2-cell gliomas roughly 200 microns in diameter formed. The team used endothelial cells derived from cow respiratory vessels, which congregated around the tumor and created the blood vessel architecture. The advantage of a 3-D model rather than Petri-dish-type analyses is that the endothelial cells attach to the tumor, rather than being separated from the substrate. This means the researchers can study their formation and growth, as well as the action of anti-therapeutic agents, just as they would in a living organism.

The researchers created a glioma, or brain tumor, and the network of blood vessels that surrounds it. In a series of experiments, the team showed that iron-oxide nanoparticles ferrying the chemical tumstatin penetrated the blood vessels that sustain the tumor with oxygen and nutrients. The iron-oxide nanoparticles are important, because they are readily taken up by endothelial cells and can be tracked by magnetic resonance imaging.

Previous experiments have shown that tumstatin was effective at blocking endothelial cell growth in gliomas. The tests by the Brown researchers took it to another level by confirming, in a 3-D, living environment, the iron-oxide nanoparticles’ ability to reach blood vessels surrounding a glioma as well as tumstatin’s ability to penetrate endothelial cells.

“The 3-D glioma model that we have developed offers a facile process to test diffusion and penetration into a glioma that is covered by a blood vessel-like coating of endothelial cells,” said Don Ho, a graduate student in the lab of chemistry professor Shouheng Sun and the lead author of the paper in the journal Theranostics. “This assay would save time and money, while reducing tests in living organisms, to examine an agent’s 3-D characteristics such as the ability for targeting and diffusion.”

The tissue model concept comes from Jeffrey Morgan, a bioengineer at Brown and a corresponding author on the paper. Building on that work, Ho and others created an agarose hydrogel mold in which rat RG2-cell gliomas roughly 200 microns in diameter formed. The team used endothelial cells derived from cow respiratory vessels, which congregated around the tumor and created the blood vessel architecture. The advantage of a 3-D model rather than Petri-dish-type analyses is that the endothelial cells attach to the tumor, rather than being separated from the substrate. This means the researchers can study their formation and growth, as well as the action of anti-therapeutic agents, just as they would in a living organism.

“You want to see nanoparticles that diffuse through the endothelial cells, which is lost in 2-D because you just have diffusion into media,” Ho said.

Other 3-D tissue models have been “forced cell arrangements,” Ho said. The 3-D glioma model, in contrast, allowed the glioma and the endothelial cells to assemble naturally, just as they would in real life. “It more clearly mimics what would actually happen,” Ho explained.

The group then attached tumstatin, part of a naturally occurring protein found in collagen, to iron-oxide nanoparticles and dosed the mold. True to form, the nanoparticles were gobbled up by the endothelial cells. In a series of in vitroexperiments, the team reported the tumstatin iron-oxide nanoparticles decreased vasculature growth 2.7 times more than under normal conditions over eight days. “The growth is pretty much flat,” Ho said. “There’s no new growth of endothelial cells.” The next step is to test the tumstatin nanoparticles’ performance in the 3-D environment.

“This model has significant potential to help in the testing and optimization of the design of therapeutic/diagnostic nanocarriers and determine their therapeutic capabilities,” the researchers write.

Contributing authors include Nathan Kohler and Aruna Sigdel, in Brown’s chemistry department; Raghu Kalluri, from the Harvard Medical School, who first discovered tumstatin’s anti-blood vessel growth properties; and Chenjie Xu, who earned his doctorate in chemistry at Brown last May and is at Brigham and Women’s Hospital in Boston.

Source:http://news.brown.edu/pressreleases/2012/02/glioma

Full story

MicroCHIPS Announces Clinical Results for First Successful Human Trial Of Implantable, Wireless Microchip Drug Delivery Device

MicroCHIPS Announces Clinical Results for First Successful Human Trial Of Implantable, Wireless Microchip Drug Delivery Device

MicroCHIPS, an MIT spin-out company out of Waltham, MA, has announced results of a clinical study evaluating its wirelessly controlled implantable drug releasing electronic microchip. The device features controllable reservoir arrays that can contain a drug or a microsensor.  The reservoirs can be opened and closed either based on a preset program, activated wirelessly through a transmitter, or based on readings of the embedded sensors.drug-delivery-microchip

The current study focused on delivering teriparatide for post menopausal women suffering from osteoporosis.  Normally these women would have to receive an unpleasant daily injection of the drug, but thanks to the MicroCHIPS device, they received a well controlled regular dose with little perceived discomfort.

Details from the press release:

In the study, seven osteoporotic postmenopausal patients between the ages of 65 and 70 received the microchip-based implant. The primary objective of the clinical trial was to assess the pharmacokinetics (PK) of the released drug teriparatide from the implanted devices. Safety measures included evaluation of the biological response to the implant and monitoring indicators of toxicity. Secondary objectives were to assess the bioactivity of the drug and to evaluate the reliability and reproducibility of releasing the drug from the device.

The device and drug combination were found to be biocompatible with no adverse immune reaction. The resulting PK profiles from the implant were comparable to and had less variation than the PK profiles of multiple, recommended subcutaneous injections of teriparatide. The study also demonstrated that the programmable implant was able to deliver the drug at scheduled intervals. Drug delivery and evaluation in patients occurred over a one month period and provided proof-of-concept measures of drug release and device durability that support implantable device viability for 12 months or more.

The microchip device was implanted and explanted using local anesthetic. Patient surveys found that the microchip device was well-tolerated, and patients indicated that they would repeat the implant procedure. “Each procedure lasted less than 30 minutes,” said treating surgeon Pia Georg Jensen, MD. “The patients were able to walk out of the facility and go home unescorted.”

To assess efficacy and improvement in bone fracture risk, the study measured biological markers of bone formation (P1NP), and bone resorption (CTX). In the study, changes in serum calcium, P1NP, and CTX resulting from drug implant therapy were found to be qualitatively and quantitatively similar to those reported in previous studies during daily subcutaneous injections of teriparatide.

“These data validate the microchip approach to multi-year drug delivery without the need for frequent injections, which can improve the management of many chronic diseases like osteoporosis where adherence to therapy is a significant problem,” said study lead author Robert Farra, MicroCHIPS President and Chief Operating Officer. “We look forward to making further progress to advance our first device toward regulatory approvals, as well as developing a range of products for use in important disease areas such as osteoporosis, cardiovascular disease, multiple sclerosis, cancer, and chronic pain.”

In the trial, post menopausal women diagnosed with osteoporosis received daily doses of the marketed osteoporosis drug teriparatide through microchip delivery rather than daily injection. The drug released from the implanted microchip demonstrated similar measures of safety and therapeutic levels in blood to what is observed from standard, recommended multiple subcutaneous injections of teriparatide.

In the study, seven osteoporotic postmenopausal patients between the ages of 65 and 70 received the microchip-based implant. The primary objective of the clinical trial was to assess the pharmacokinetics (PK) of the released drug teriparatide from the implanted devices. Safety measures included evaluation of the biological response to the implant and monitoring indicators of toxicity. Secondary objectives were to assess the bioactivity of the drug and to evaluate the reliability and reproducibility of releasing the drug from the device.

The device and drug combination were found to be biocompatible with no adverse immune reaction. The resulting PK profiles from the implant were comparable to and had less variation than the PK profiles of multiple, recommended subcutaneous injections of teriparatide. The study also demonstrated that the programmable implant was able to deliver the drug at scheduled intervals. Drug delivery and evaluation in patients occurred over a one month period and provided proof-of-concept measures of drug release and device durability that support implantable device viability for 12 months or more.

The microchip device was implanted and explanted using local anesthetic. Patient surveys found that the microchip device was well-tolerated, and patients indicated that they would repeat the implant procedure. “Each procedure lasted less than 30 minutes,” said treating surgeon Pia Georg Jensen, MD. “The patients were able to walk out of the facility and go home unescorted.”

To assess efficacy and improvement in bone fracture risk, the study measured biological markers of bone formation (P1NP), and bone resorption (CTX). In the study, changes in serum calcium, P1NP, and CTX resulting from drug implant therapy were found to be qualitatively and quantitatively similar to those reported in previous studies during daily subcutaneous injections of teriparatide.

“A microchip that continues to deliver teriparatide with this or similar consistency and efficiency over 12 to 24 months could improve bone mass, density, architecture, and strength,” said study co-author Robert Neer, Founder & Director of the Massachusetts General Hospital Bone Density Center and Associate Professor of Medicine at Harvard Medical School.

Implantable medical devices such as pacemakers and pain pumps perform important functions to help patients return to a healthier state and to manage their disease. The design of a next-generation microchip drug delivery device is the only approach to an implantable device that can be wirelessly programmed to release drugs inside the body without percutaneous connections in or on the patient. An implantable microchip device also provides real-time dose schedule tracking, and as part of a network, physicians can remotely adjust treatment schedules as necessary.

“This trial demonstrates how drug can be delivered through an implantable device that can be monitored and controlled remotely, providing new opportunities to improve treatment for patients and to realize the potential of telemedicine,” said study co-author Robert Langer, ScD, Institute Professor at the David H. Koch Institute for Integrative Cancer Research at MIT, and cofounder of MicroCHIPS, Inc. “The convergence of drug delivery and electronic technologies gives physicians a real-time connection to their patient’s health, and patients are freed from the daily reminder, or burden, of disease by eliminating the need for regular injections.”

MicroCHIPS is currently developing new designs of its microchip-based implant to include as many as 400 doses per device providing daily dosing for one year or multi-year therapy for less frequent dosing regimens. Components of the original microchip technology, such as the array of micro reservoirs used to contain drug and the first microchip opening mechanism, were developed at the Massachusetts Institute of Technology and licensed to MicroCHIPS.

Source:http://www.mchips.com/12_Feb_16_pr.html

Full story

Therapy Cool Path Duo™ Ablation Catheter, Safire BLU Duo™

Therapy Cool Path Duo™ Ablation Catheter, Safire BLU Duo™

The FDA granted pre-market approval to St. Jude Medical for the company’s Therapy Cool Path Duo and Safire Blu Duo cardiac ablation catheters and the matching IBI1500T9-CP V1.6 generator to power them.Therapy-Cool-Path-Duo

The catheters provide cooling irrigation all around the tip from a dozen ports so that only targeted tissue is destroyed.  The system is already cleared for marketing in Europe.

Some of the features:

  • Externally irrigated ablation catheter with additional irrigation ports for more uniform cooling
  • Lower average measured tip temperature at equivalent flow rates compared to distal tip irrigation only 
  • Fewer incidences of coagulum and charring observed in preliminary study
  • All-braided construction provides uninterrupted torque transfer for more responsive handling
  • M, L, XL, and L1 curve configurations

This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.

Product Name: Therapy Cool Path Duo™ Ablation Catheter, Safire BLU Duo™ Ablation Catheter, and IBI1500T9-CP V1.6 Cardiac Ablation Generato
PMA Applicant: Irvine Biomedical, Inc., A St. Jude Medical Company
Address: 2375 Morse Ave., Irvine, CA 92614
Approval Date: January 25, 2012
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf11/p110016a.pdf

What is it? The Therapy Cool Path Duo™ Ablation Catheter or the Safire BLU Duo™ Ablation Catheter is a steerable, deflectable, irrigated catheter (a long, thin, flexible tube) used to treat a certain kind of abnormal heart rhythm (arrhythmia) called typical atrial flutter by finding the source of the rhythm disturbance and destroying (ablating) small areas of the heart tissue. The catheters take energy from an external source (the IBI1500T9-CP V1.6 Cardiac Ablation Generator) to a point in the right side of the heart.

How does it work? The Therapy Cool Path Duo™ Ablation Catheter or the Safire BLU Duo™ Ablation Catheter is inserted into a blood vessel (artery or vein), usually though a site in the upper leg or neck. The catheter is manually advanced through the blood vessels until it reaches the correct location inside the heart. The tip of the catheter is moved around by a mechanism on the handle. Inside the heart, electrodes at the tip gather data that pinpoint the location of the faulty tissue in the heart (electrical mapping). Once the site is identified, the device delivers radiofrequency (RF) energy to destroy the small areas of tissue that blocks the heart’s internal electrical signals that cause the typical atrial flutter. The catheters are removed after treatment.

When is it used? The Therapy Cool Path Duo™ Ablation Catheter or the Safire BLU Duo™ Ablation Catheter, and the IBI 1500T9-CP V1.6 Cardiac Ablation Generator are used to destroy small areas in the heart that cause an abnormally fast heart beat or abnormal heart rhythm in the upper chambers (the atria) of the heart. The technical name for this kind of abnormal heart beat is typical atrial flutter.

What will it accomplish? Cardiac catheter ablation can cure typical atrial flutter and restore a normal heart rhythm, and in other cases, can reduce the frequency of episodes that a patient experiences. In a clinical study involving 188 patients, the abnormal rhythm (typical atrial flutter) was corrected in 181 patients (96%) for 7 days after treatment; and it remained corrected after 3 months in 174 patients (94.5%).

When should it not be used? The device should not be used in patients:

Full story

POLARCUP Dual Mobility Hip System

POLARCUP Dual Mobility Hip System

It’s been implanted in Europe and other places outside the U.S. for over a decade, and the company says that the implant can deliver lower wear and dislocation rates when compared to competing devices.SN-POLARCUP

The system is specifically designed to address the challenges of treating patients – in both primary and revision cases – who are susceptible to dislocation and need enhanced stability.  Backed by 10 years of clinical history in Europe and other markets outside the US, the POLARCUP System allows surgeons to implant a smaller, constrained femoral component within a larger, anatomically sized polyethylene head, thus providing greater stability by increasing range of motion and jump distance.

February 9, 2012 – Smith & Nephew (NYSE:SNN;LSE:SN), the global medical technology business, is introducing the clinically proven POLARCUP◊ Dual Mobility Hip System to orthopaedic surgeons in the US at this year’s American Academy of Orthopaedic Surgeons (AAOS) annual meeting in San Francisco. The system is specifically designed to address the challenges of treating patients – in both primary and revision cases – who are susceptible to dislocation and need enhanced stability.

Backed by 10 years of clinical history in Europe and other markets outside the US, the POLARCUP System allows surgeons to implant a smaller, constrained femoral component within a larger, anatomically sized polyethylene head, thus providing greater stability by increasing range of motion and jump distance. “This stability philosophy is widely used in the European market where surgeons have extensive experience with dual mobility in elderly and less active patients,” says John Soto, Senior Vice President for Smith & Nephew’s Global Hip Franchise.

The POLARCUP System is a complement to the company’s clinically proven BIRMINGHAM™ Hip Resurfacing System, which provides stability and durability for the young active patient.

Source:http://global.smith-nephew.com/master/40746.htm

Full story

Integra LifeSciences Announces Launch of the Integra(R) Allograft Wedge System for Extremity Reconstruction

Integra LifeSciences Announces Launch of the Integra(R) Allograft Wedge System for Extremity Reconstruction

Integra LifeSciences recently announced the launch of the Integra Allograft Wedge System, their pre-cut allograft wedges for Evans and Cotton osteotomies. Osteotomies are procedures in which bone is cut and then re-aligned, often with new bone placed as a wedge to secure the new position. The Cotton osteotomy involves the medial cuneiform and is used to correct rotational deformities of the forefoot. The Evans osteotomy, on the other hand, is a lengthening procedure for the calcaneus (heel bone) used most commonly for treating flatfeet. Both osteotomies involve placing a wedge of bone that is often harvested from the patient (autograft). While autograft provides superior structural and healing qualities to donated bone (allograft), harvesting it can cause significant pain and lengthen patient recovery.Integra-Allograft-Wedge-System

Integra’s new Allograft Wedge System has pre-cut wedges in four sizes: 6, 8, 10 and 12mm. This theoretically should allow for more efficient procedures by bypassing some of the measuring and shaping of the graft material that needs to take place.

More from the press release:

Integra LifeSciences Holdings Corporation (Nasdaq:IART) announced today the introduction of Integra(R) Allograft Wedge System, which consists of simple pre-cut allograft wedges for both Evans and Cotton osteotomies and a dedicated instrumentation set that is designed to provide a method of assessing osteotomy space to aid in the selection of the appropriate Integra(R) Allograft Wedge implant.

The Integra(R) Allograft Wedge is processed from human cancellous bone, sterilized through the BioCleanse(R) Tissue Sterilization Process and terminally sterilized using a validated method to achieve a Sterility Assurance Level (SAL) of 10-6. The wedge provides a natural scaffold for bone growth, as well as biologic stability and structural support for deformity corrections. It also eliminates significant harvest site morbidity that may result from autograft removal. Integra will feature the implant at the American Academy of Orthopaedic Surgeons Annual Meeting, February 7-11, 2012 in San Francisco, California.

“Integra(R) Allograft Wedge System offers four sizes (6, 8, 10 and 12mm), which gives surgeons a significant addition to their treatment options and helps limit uncertainty by accommodating a patient’s unique surgical needs,” said Bill Weber, Vice President and General Manager, Integra Extremity Reconstruction.

PLAINSBORO, N.J., Feb. 8, 2012 (GLOBE NEWSWIRE) – Integra LifeSciences Holdings Corporation (Nasdaq:IART) announced today the introduction of Integra® Allograft Wedge System, which consists of simple pre-cut allograft wedges for both Evans and Cotton osteotomies and a dedicated instrumentation set that is designed to provide a method of assessing osteotomy space to aid in the selection of the appropriate Integra® Allograft Wedge implant.

Osteotomies are procedures in which surgeons realign or remove a segment of bone located near a damaged joint to help correct deformities, typically in the foot. Integra® Allograft Wedge is designed to provide bone grafting material for osteotomy corrections. The Integra® Allograft Wedge is processed from human cancellous bone, sterilized through the BioCleanse® Tissue Sterilization Process and terminally sterilized using a validated method to achieve a Sterility Assurance Level (SAL) of 10-6. The wedge provides a natural scaffold for bone growth, as well as biologic stability and structural support for deformity corrections. It also eliminates significant harvest site morbidity that may result from autograft removal. Integra will feature the implant at the American Academy of Orthopaedic Surgeons Annual Meeting, February 7-11, 2012 in San Francisco, California.

“Integra® Allograft Wedge System offers four sizes (6, 8, 10 and 12mm), which gives surgeons a significant addition to their treatment options and helps limit uncertainty by accommodating a patient’s unique surgical needs,” said Bill Weber, Vice President and General Manager, Integra Extremity Reconstruction.

The Integra® Allograft Wedge System is distributed through Integra’s Extremity Reconstruction sales organization, which focuses on lower extremity fixation, upper extremity fixation, tendon protection, peripheral nerve repair/protection and wound repair.

Integra LifeSciences, a world leader in medical devices, is dedicated to limiting uncertainty for surgeons, so they can concentrate on providing the best patient care.  Integra offers innovative solutions in orthopedics, neurosurgery, spine, reconstructive and general surgery. For more information, please visit www.integralife.com.

This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements concerning the products and services provided by Integra. Such forward looking statements involve risks and uncertainties that could cause actual results to differ materially from predicted or expected results.  Among other things, the willingness of surgical professionals to use Integra products may affect the prospects for their use in surgical procedures. In addition, the economic, competitive, governmental, technological and other factors, identified under the heading “Risk Factors” included in Item IA of Integra’s Annual Report on Form 10-K for the year ended December 31, 2010 and information contained in subsequent filings with the Securities and Exchange Commission could affect actual results.

Source:http://investor.integralife.com/releasedetail.cfm?ReleaseID=647134&keepThis=true&TB_iframe=true&height=550&width=790

Related Posts Plugin for WordPress, Blogger...

Full story

Page 1 of 1612345...10...Last »
Copyright © 2017 Medical Technology & Gadgets Blog MedicalBuy.net. All rights reserved.
Proudly powered by WordPress. Developed by Deluxe Themes