Posts Tagged ‘health insurance’

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Survey reveals increase in use of EMRs among U.S. primary care physicians

Survey reveals increase in use of EMRs among U.S. primary care physicians

Survey of 10 countries finds US Primary care doctors most likely to spend time dealing with insurance restrictions; Majority support fundamental health system change; All countries need to improve communication about patient care

Two-thirds (69%) of U.S. primary care physicians reported using electronic medical records (EMRs) in 2012, up from less than half (46%) in 2009, according to findings from the 2012 Commonwealth Fund International Health Policy Survey, published as a Web First online today in the journal Health Affairs. Primary care physicians in the U.S.-the only country in the study without universal health coverage-stand out in the survey for reporting that their patients often cannot afford care (59%). By comparison, between 4 percent and 25 percent of physicians reported affordability problems for their patients in Norway (4%), the U.K. (13%), Switzerland (16%), Germany (21%), and Australia (25%). Moreover, more than half of U.S. doctors (52%) said insurance restrictions on their care decisions are a major time concern-by far the highest rate in the 10-country survey. U.S. physicians also were the most negative about their country’s health system, with only 15 percent agreeing the health care system works well.

The survey of nearly 8,500 primary care physicians in Australia, Canada, France, Germany, the Netherlands, New Zealand, Norway, Switzerland, the United Kingdom, and the United States, finds that communication and teamwork across the health system is a challenge in all countries. In each, only a minority of primary care doctors reported always receiving timely information from specialist physicians after referring patients to them; in the U.S., just 11 percent of physicians said they had such information available when it was needed. And from one-third to more than half of doctors across countries said they are not always notified when their patients leave the hospital.

In the study, “A Survey of Primary Care Doctors in Ten Countries Shows Progress in the Use of Health Information Technology, Less in Other Areas,” the U.S. stands out for having the lowest rates of after-hours care: one-third (34%) of U.S. physicians reported they provided options for their patients to receive after-hours care, compared to about 90 percent or more in the U.K (95%), the Netherlands (94%), New Zealand (90%), and Germany (89%).

“The U.S. spends far more on medical care than the other countries we surveyed, yet our doctors are telling us their patients can’t afford care, they don’t always have the patient information they need, they spend too much time dealing with insurance companies, and we need major change,” said Commonwealth Fund senior vice president Cathy Schoen, lead author of the study. “The insurance expansions under the Affordable Care Act will make care more affordable-but we also need to simplify insurance to free up physicians to provide timely access to high-quality care for their patients.”

Use of Health Information Technology

According to the survey, while the U.S. and Canada have made improvements in health information technology use, both countries continue to lag behind the leaders in EMR use and the range of functions supported by practice systems. In fact, just 27 percent of U.S. physicians and 10 percent of Canadian practices indicated their systems have multi-functional capacity, with the ability to: generate patient information, such as medication lists; manage patient registries, such as seeing which patients are overdue for care; order prescriptions or diagnostic tests electronically; or provide decision support, such as alerts about drug interactions. In contrast, 68 percent of U.K. practices and 59 to 60 percent of New Zealand and Australian practices reported having such multi-functional capacity.

Providing patients with electronic access appears to be spreading. The survey found that about a third of U.S. doctors allow patients to request prescription refills online (36%) or e-mail a medical question (34%). Physicians in other countries have also expanded such electronic access: for example, two-thirds (68%) of Swiss doctors provide e-mail access, and more than half of Dutch (63%), Norwegian (53%), and U.K. (56%) doctors said their patients can request prescription refills electronically.

However, the ability of primary care physicians to exchange information electronically with doctors outside their practice is not routine in any country. New Zealand, the Netherlands, and Switzerland lead on information exchange, with about half of the doctors having that capability, compared to 31 percent of doctors in the U.S.

“The substantial increase in U.S doctors’ use of electronic medical record systems reflects the incentives and national investment included in the 2009 economic stimulus legislation,” said Commonwealth Fund president Karen Davis. “As we look to the future, we hope to see similar progress as health reform provisions take hold, including patient-centered medical homes and health care systems that foster teamwork and coordination. With improvements in these areas, we will be able to improve patient outcomes and experiences, and make a positive difference for physicians.”

Primary care doctors’ reports on receiving information back from specialists and hospitals about care provided to their patients indicate that communication and teamwork are challenges shared by all the countries. Only a minority of primary care doctors reported they always receive timely information from specialists after a referral (the rates range from 1% to 27%), while less than half of doctors in any country said they always know about changes to their patients’ medications or care plans. And a third to more than half of primary care physicians in all countries said they are not always notified when their patients are discharged from a hospital or seen in an emergency department. U.S. doctors’ reports on receiving timely, consistent communications from specialists and hospitals were generally near the bottom of the country range.

Additional Survey Findings

Primary care physicians’ reports about their patients’ access to specialists varied widely: 10 percent of Swiss doctors, compared to three-fourths of Canadian and New Zealand doctors, said their patients often face long waits to see a specialist. Twenty-eight percent of U.S. doctors-the same percentage of U.K. doctors-also voiced this concern.

To provide incentives for quality improvement, many of the countries have been investing in making information available on physician performance. U.K. doctors stand out for getting feedback on their performance: 84 percent of U.K. primary care practices reported they routinely receive and review data on clinical outcomes, 82 percent receive data on hospital admissions and emergency room use, and 78 percent have comparative data available-by far the highest rates in the survey. U.S. primary care doctors are in the middle of the range for having performance information on clinical outcomes (47%) and data for comparing themselves with other practices (34%).

Within the U.S., physicians who reported that they spend a lot of time on insurance restrictions or that their patients have access problems were the most likely to call for major change and were the most negative about practicing medicine.

The authors of the study observe that physician experiences underscore the importance of national policies, including those concerning health insurance design, investment in information systems, and the resources necessary to support primary care practices. “Although U.S. health information technology adoption has increased, the study points to the need for intensified efforts to link practice information systems to enable communication and collaboration across care sites,” they write. With the redesign of primary care central to U.S. efforts to improve health outcomes and care experiences while reducing costs, they conclude that “listening to doctors on the front lines of primary care can help identify gaps and target reforms.”

Source : http://www.news-medical.net/news/20121115/Survey-reveals-increase-in-use-of-EMRs-among-US-primary-care-physicians.aspx

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Most pediatric hospital physicians communicate through cell phone text messaging

Most pediatric hospital physicians communicate through cell phone text messaging

More pediatric hospital physicians are communicating through cell phone text messaging, rather than the traditional pager method, according to research presented Oct. 21 at the American Academy of Pediatrics (AAP) National Conference and Exhibition in New Orleans.

Since the early 1980s, physicians traditionally have relied on pagers to contact other physicians, residents, nurses and hospital staff. However, with the surge in cellphone use – and the fact that many cellphones now accept pages – many physicians and staff are sending text messages with questions and requests for assistance.

In the study, “Text Messaging as a Means of Communication among Pediatric Hospitalists,” researchers administered an electronic survey to 106 pediatric hospital physicians. The majority of the physicians surveyed were female (68 percent) and had been in practice less than 10 years (62 percent). Ninety percent of responders regularly used a smartphone and 96 percent used text messaging.

The most frequent method of communication in the hospital setting was verbal face-to-face communication (92 percent) and telephone conversation (92 percent). However, more than half of the physicians interviewed (57 percent) reported either sending or receiving work-related text messages, of whom 12 percent reported sending more than 10 messages per shift. Nearly half (49 percent) also reported receiving work-related text messages when not scheduled to be on call. Most often these text messages were to or from other pediatric hospitalists (59 percent), fellows or resident physicians (34 percent), or subspecialists and consulting physicians (25 percent).

Forty-one percent of respondents reportedly received text messages on a personal phone, and 18 percent to a hospital-assigned phone. Twenty-seven percent said they preferred texting for brief communications; 23 percent preferred a hospital assigned pager; and 21 percent preferred verbal face-to-face communication.

Few physicians reported that their hospital had a policy for texting or Health Insurance Portability and Protection Act (HIPPA)-encrypted software for texting.

“We are using text messaging more and more to communicate with other physicians, residents and even to transfer a patient to a different unit,” said abstract author Stephanie Kuhlmann, MD. “We’ve had such a rapid increase in cellphone use, and I’m not sure that hospitals have caught up by putting in place related processes and protocols.”

We also need to look at life balance,” said Dr. Kuhlman. “It’s not easy to leave your cellphone when you’re not at work. People still can contact you.”

Source : http://www.news-medical.net/news/20121023/Most-pediatric-hospital-physicians-communicate-through-cell-phone-text-messaging.aspx

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State highlights: Free Calif. health care clinic a big draw; New Calif. law could mean mammogram alternatives

State highlights: Free Calif. health care clinic a big draw; New Calif. law could mean mammogram alternatives

A selection of health policy stories from California and North Carolina.

Los Angeles Times: Free Health Care Clinic At LA Sports Arena Draws 4,800

Many of the 4,800 people seeking care at the annual massive free clinic this weekend will become eligible for health insurance in 2014 when the national law takes effect. Organizers said raising awareness about the health care changes is crucial (Gorman, 9/27).

San Francisco Chronicle: Law May Encourage Mammogram Alternatives

A new law that will require California doctors to tell women if they have highly dense breast tissue is expected to increase demand for alternatives to mammography to screen patients for breast cancer. The potential market is huge: About 40 percent of women have tissue that is dense enough that cancer may be missed through conventional mammography. The law says that beginning in April, patients must be told a “range of screening options” are available, but it does not specify those methods or require health insurers to cover them (Colliver, 9/27).

California Healthline: New Attention To End-Of-Life Care

Partnership HealthPlan of California, a health insurer covering roughly 200,000 Medi-Cal beneficiaries in six Northern California counties, has decided to offer the optional benefit of palliative care to its members. … The state doesn’t currently offer the enhanced benefit, in part due to budget concerns, but [Partnership HealthPlan's medical director] said the cost of palliative care is offset by less necessity to provide other types of care that may not actually benefit the patient or the family, he said (Gorn, 9/28).

North Carolina Health News: Public Health Workers Express Frustration With New Law

With the passage of a new law this past year, county public health agencies could look very different — and some public health professionals are making their unhappiness about it known. At a meeting of the N.C. Public Health Association last week at the New Bern Convention Center, state Sen. Fletcher Hartsell (R-Cabarrus) was forced to defend a bill he shepherded through during this year’s legislative session that allows county boards of commissioners to disband local boards of health and assume their powers. The new law also allows for county commissioners to consolidate public health and social services agencies, and creates incentives for smaller counties to join together to provide services across county lines (Hoban, 9/27).

http://www.kaiserhealthnews.orgThis article was reprinted from kaiserhealthnews.org with permission from the Henry J. Kaiser Family Foundation. Kaiser Health News, an editorially independent news service, is a program of the Kaiser Family Foundation, a nonpartisan health care policy research organization unaffiliated with Kaiser Permanente.

Source : http://www.news-medical.net/news/20120929/State-highlights-Free-Calif-health-care-clinic-a-big-draw3b-New-Calif-law-could-mean-mammogram-alternatives.aspx

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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

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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.

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’ 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.

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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

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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

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Medasys Inc. Announces FDA Approval for Implantable Programmable Drug Pump

Medasys Inc. Announces FDA Approval for Implantable Programmable Drug Pump

Medasys has received FDA pre-market approval for its Prometra programmable implantable drug pump. The Prometra is a non-peristaltic programmable implantable pump that delivers INFUMORPH (preservative-free morphine sulfate sterile solution) intrathecally for the management of pain.Medasys-Prometra-morphine-pump

The Prometra makes use of a valve gated precision dosing system to achieve high accuracy, minimizing dose variations due to temperature, pressure, flow rate, or reservoir fill levels. It has a minimal amount of moving parts and no complex gears and rotors.

The pump is implanted near the spine and has a microcatheter that runs to the intrathecal area of the lower spine. The intrathecal delivery makes it possible to use very low doses compared to other routes of administration, thus minimizing the risk of side-effects and lowering the amount of medication needed in the reservoir. The reservoir can be refilled percutaneously with a syringe and a needle.

MOUNT OLIVE, N.J., Feb. 13, 2012 /PRNewswire/ – Medasys Inc., a medical device company focused on providing implantable drug delivery solutions, announced today that it has received PMA approval from the U. S. Food and Drug Administration (FDA)  for its Prometra® programmable implantable drug pump.   Prometra will be the first non-peristaltic programmable implantable pump that has received FDA approval for delivery of INFUMORPH (preservative-free morphine sulfate sterile solution).  INFUMORPH is indicated for intraspinal administration for the management of pain.

In addition to meeting all of the PMA safety and effectiveness requirements, a clinical trial demonstrated 97% clinical accuracy in the delivery of the physician-programmed dose, the highest labeled accuracy available for this type of pump.

“We are pleased to be able to utilize our engineering expertise and intellectual property to advance intrathecal therapy in the U.S.,” Steve Adler, President and CEO of Medasys commented. “Prometra represents the first significant evolution in pump technology available in the US in over 15 years.”

Advances in the Prometra pump design are intended to maximize device longevity and dose delivery accuracy. By reducing the number of moving parts and eliminating complex gears and rotors, pump dependability and reliability should be greatly improved. The Prometra also makes use of a patented valve gated precision dosing system to achieve extremely high accuracy, minimizing dose variations due to temperature, pressure, flow rate, or reservoir fill levels. It is expected that the combination of these factors will contribute to improved pain management.

It is estimated that 116 million people in the U.S. suffer with chronic pain. Continuous intrathecal delivery of INFUMORPH using a microinfusion device (e.g., implantable drug delivery pump) is a therapeutic option used for the management of chronic pain.  Chronic pain can be debilitating, disabling, and negatively impact quality of life. The Prometra offers patients and physicians a new highly accurate option for drug delivery.

About Medasys
Medasys’ strategic goal is to become the leading implantable drug delivery company in the world. Founded in 2005, Medasys received approval to conduct its first clinical trial in 2007 on the Prometra programmable implantable pump. Medasys received approval by the FDA to market the Prometra in 2012. Medasys has been granted multiple patents, and is focused on working closely with physicians to rapidly improve the capabilities of implantable drug delivery and management systems.

For more information see the Medasys web site at: http://www.MedasysPumps.com.

Forward-Looking Statements
This press release contains forward-looking statements. The Company wishes to caution the reader of this press release that actual results may differ from those discussed in the forward-looking statements and may be adversely affected by, among other things, reimbursement policies, commercialization of new technologies, intellectual property, and other factors.

Source:http://www.prnewswire.com/news-releases/medasys-inc-announces-fda-approval-for-implantable-programmable-drug-pump-139208249.html

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UGA discovery uses ‘fracture putty’ to repair broken bone

UGA discovery uses ‘fracture putty’ to repair broken bone

Researchers at the University of Georgia Regenerative Bioscience Center in cooperation with the U.S. Department of Defense are developing a new “fracture putty” with the aim of  significantly shortening the healing time of bone fractures in humans. According to the researchers, complex fractures can often lead to amputations for U.S. service men and women. The lengthy healing time often associated with these injuries can also prove to be a major burden for the patients and providers.putty-for-bone-repair

The research team is using adult stem cells to produce proteins involved in bone healing and generation. They incorporate these proteins into a gel which they have dubbed “fracture putty”. To date the team has demonstrated some positive early results by using the putty to repair fractures in lab rats. After two weeks the rats were observed running around and standing on their hind legs with no evidence of injury. The putty is currently being used in large animal trials, but it may be some time before human testing commences.

Athens, Ga. – Broken bones in humans and animals are painful and often take months to heal. Studies conducted in part by University of Georgia Regenerative Bioscience Center researchers show promise to significantly shorten the healing time and revolutionize the course of fracture treatment.

“Complex fractures are a major cause of amputation of limbs for U.S. military men and women,” said Steve Stice, a Georgia Research Alliance Eminent Scholar, animal and dairy scientist in the UGA College of Agricultural and Environmental Sciences and director of the UGA Regenerative Bioscience Center.

“For many young soldiers, their mental health becomes a real issue when they are confined to a bed for three to six months after an injury,” he said. “This discovery may allow them to be up and moving as fast as days afterward.”

Stice is working with Dr. John Peroni to develop a fast bone healing process. “This process addresses both human and veterinary orthopedic needs,” said Peroni, an associate professor of large animal surgery in the UGA College of Veterinary Medicine and a member of the RBC.

Peroni and Stice are leading a large animal research project funded by the U.S. Department of Defense. The project includes scientists and surgeons from the Baylor College of Medicine, Rice University and the University of Texas, who conducted the early studies.

Engineering new bone
“Healing of critical-size defects is a major challenge to the orthopedic research community,” Peroni said. “Large-bone defects must be stabilized and necessitate technologies that induce rapid bone formation in order to replace the missing tissue and allow the individual to return to rapid function. To date, no single material can suffice.”

The group they lead is a multidiscipline and multi-institutional group actively working on bone tissue engineering.

“Our group has been working productively together on numerous projects through the last several years,” Stice said, “So, a collegial relationship and successful collaborative working relationship is already established.”

Between 2009 and 2011, the collaborations received a $1.4 million grant from the DOD for the use of stem cells in fracture healing to be tested in sheep.

“In our experiences with large animal models, following the guidelines established by our animal care and use committee,” Stice said, “we have been successful in formulating a product that contains mesenchymal stem cells and allows them to survive in the environment of the fracture long enough to elicit the rapid formation of new bone.”

This year, the group showed bone can be generated in sheep in less than four weeks. The speed in which bone is formed is one of the truly unique features of this study.

Fracture putty
To start the bone regeneration process, the RBC used adult stem cells that produce a protein involved in bone healing and generation. They then incorporated them into a gel, combining the healing properties into something Stice calls “fracture putty.”

With Peroni’s assistance, the Houston-based team used a stabilizing device and inserted putty into fractures in rats. Video of the healed animals at two weeks shows the rats running around and standing on their hind legs with no evidence of injury. The RBC researchers are testing the material in pigs and sheep, too.

“The small-animal work has progressed, and we are making good progress in large animals,” he said.

More work is needed to get to human medical trials, but the threat of losing federal funding for biomedical work through the DOD means they will have to find new ways to fund the project.

Next steps
“The next step is to show that we can rapidly and consistently heal fractures in a large animal,” Peroni said, “then to convert it to clinical cases in the UGA [College of Veterinary Medicine] clinics where clinicians treat animals with complex fractures all the time.”

Once they have something that works for animals, it will be passed over to the DOD for human use.

Peroni, who is chairman of the North American Veterinary Regenerative Medicine Association, is hopeful this material will be promoted to the veterinary and human medical fields through the educational efforts of NAVRMA and the RBC.

However, the RBC isn’t the only group working on a faster fix for broken bones.

“Our approach is biological with the putty,” Stice said. “Other groups are looking at polymers and engineering approaches like implants and replacements which may eventually be combined with our approach. We are looking at other applications, too, using this gel, or putty, to improve spinal fusion outcomes.”

Source:http://news.uga.edu/releases/article/uga-discovery-uses-fracture-putty-to-repair-broken-bone-in-days/

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