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Clinical Trial Completed on New Two-Part Heart Valve

July 25, 2013 11:08 am | by ValveXchange | News | Comments

Surgeons in Europe have completed clinical trials on the world’s first serviceable bioprosthetic heart valve, paving the way for the CE mark and commercial sale of an advanced heart valve that eliminates many common problems for cardiac valve patients.

‘Standards’ for Home Healthcare

July 23, 2013 4:44 pm | by Todd Konieczny, Assistant Chief Engineer, Americas Region; Technical Manager, Medical Division, Intertek | Blogs | Comments

The following standard must be met for all medical products intended to be used in the home: IEC 60601-1-11, which is “Medical Electrical Equipment—Part 1-11: General Requirements for Basic Safety and Essential Performance—Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment.”

Researchers Put Squeeze on Cells to Deliver

July 23, 2013 11:12 am | by National Institute of Biomedical Imaging and Bioengineering | News | Comments

Imagine being able to redirect powerful immune cells to fight cancer. How about reprogramming a diabetic’s skin cell into a cell that could manufacture the insulin their pancreas no longer produces? These are major health problems and medical challenges that may be more achievable with a new fundamental technology that gets vital control molecules into cells faster, safer, and more effectively.


Steering Stem Cells with Magnets

July 23, 2013 10:19 am | by Emory University | News | Comments

Magnets could be a tool for directing stem cells’ healing powers to treat conditions such as heart disease or vascular disease. By feeding stem cells tiny particles made of magnetized iron oxide, scientists at Emory and Georgia Tech can then use magnets to attract the cells to a particular location in a mouse's body after intravenous injection.

BMC Surgeon Recommends Off-Pump Coronary Artery Bypass Grafting Be Abandoned

July 23, 2013 10:04 am | by Boston University Medical Center | News | Comments

In a Special Report in the current issue of Circulation, Boston Medical Center cardiothoracic surgeon Harold Lazar, MD, has found that off-pump coronary artery bypass graft (OPCAB) surgery has failed to show any significant improvement in short-term morbidity or mortality as compared to the traditional on-pump coronary artery bypass graft (CABG) surgery.

Brookhaven Medical Makes $5 Million Investment In CreatiVasc Medical’s New Dialysis Device and System

July 23, 2013 10:00 am | by Business Wire | News | Comments

Brookhaven Medical, Inc., an Atlanta based medical device company with interests in dialysis devices and advanced wound care, announced today that it has made a strategic investment of up to $5 million into CreatiVasc Medical, Inc. of Greenville, South Carolina.

Temperature-Resistant Microchip to be Used for UDI Compliance for Implantables

July 23, 2013 8:30 am | by Business Wire | News | Comments

Digital Angel Corporation, following its recent share exchange with VeriTeQ Acquisition Corporation, announced that VeriTeQ filed a provisional patent with the U.S. Patent and Trademark Office in September 2012 for a microchip that is able to withstand high temperatures in order to make it compatible with the sterilization processes involved in the manufacturing of implantable medical devices.

IEC 60601-2-34 Issue 3: Changes to Recovery Test

July 22, 2013 2:11 pm | by Jeff Lind, CEO & Jose Cabanillas, Hardware Engineer, Compliance West USA | Compliance West USA | Articles | Comments

The IEC has made a change to the Recovery Test, 60601-2-34. Issue 3 offers modifications that make it more beneficial for engineers as a custom test system is no longer required for this specific test. This article reviews the full breadth of the test and how it can impact medical device manufacturers.


MicroVention Announces First Trial Enrollment In Their U.S. Clinical Trial Of Its New Dual-Layer Stent For Cerebral Aneurysm Flow Diversion

July 22, 2013 10:00 am | by The Associated Press | News | Comments

MicroVention, Inc., a wholly owned subsidiary of Terumo Corporation, announced earlier last week that they successfully completed their first enrollment in a multi-center, prospective, pivotal U.S. clinical trial to demonstrate the safety and efficacy of its FREDT flow diversion system (FREDT-Flow Re-Direction Endoluminal Device) for treating intracranial aneurysms.

Biosan Medical Receives U.S. Patent for Its Novel Device and Method of Treating the Deadliest Type of Stroke, Subarachnoid Hemorrhage (SAH), and Alzheimer’s Disease

July 22, 2013 9:24 am | by Business Wire | News | Comments

Biosan Medical, an emerging medical device company, announced today that it has been issued U.S. Provisional Patent No. 61,957,293 for its revolutionary Ventritek105® Stroke Treatment Device and Method (“Device & method for CSF auto-transfusion therapy for the treatment of SAH (subarachnoid hemorrhage), Alzheimer’s Disease & other Neuro-Degenerative CNS diseases”).

First Robotic-Assisted Stent Placement in Acute Heart-Attack Patient Performed

July 18, 2013 2:38 pm | by Business Wire | News | Comments

Corindus Vascular Robotics announced today that Sanford Aberdeen Medical Center in Aberdeen, S.D. became the first hospital to perform a Robotic Angioplasty for a patient with an acute heart-attack, achieving a far better door-to-balloon time than the national standard.

ValveXchange applies for EU approval of a 2-part transcatheter valve

July 18, 2013 12:29 pm | by Mass Device | News | Comments

ValveXchange has its sights set on winning regulatory approval in Europe for its Vitality device, a product the company touts as the 1st serviceable bioprosthetic heart valve. Clinical trial enrollment to support European CE Mark approval wrapped up last month, and ValveXchange submitted all of its paperwork to the regulatory body DERKA Certification this week, according to a press release.

Mother of Four with Heart Defect & Biventricular Heart Failure Bridged to Transplant with Artificial Heart

July 18, 2013 10:15 am | by PR Newswire | News | Comments

Last October, when a virus attacked Stacie Sumandig’s aortic valve and destroyed her heart, the news she received at two different hospitals was grim: she probably wouldn't make it through the weekend. Sumandig was transferred to the University of Washington (UW) Medical Center in Seattle, where doctors offered her one final option that hadn't been available at the two previous hospitals.


Imaging System Detects Cholesterol-Rich Plaque at the Culprit Site in Patients with Heart Attacks

July 17, 2013 3:30 pm | by Business Wire | News | Comments

Infraredx, Inc., a medical device company committed to advancing the diagnosis and management of coronary artery disease, today announced the publication of key data supporting the ability of its TVC Imaging System to detect lipid core plaque in patients with ST-Segment Elevation Myocardial Infarction (STEMI).

TriVascular Annouces Post-Approval Study of the Ovation Prime

July 17, 2013 1:12 pm | by TriVascular | News | Comments

TriVascular has announced the initiation of a U.S. Post-Approval Study (PAS) of the Ovation Prime Abdominal Stent Graft System for the treatment of abdominal aortic aneurysms (AAA).           

Gold Nanofibers in Engineered Heart Can Enhance Electrical Signalling

July 17, 2013 1:00 pm | by Tel Aviv University | News | Comments

Heart tissue sustains irreparable damage in the wake of a heart attack. Because cells in the heart cannot multiply and the cardiac muscle contains few stem cells, the tissue is unable to repair itself — it becomes fibrotic and cannot contract properly.

Covidien launches 2 trials to support its Stellarex drug-device combo

July 17, 2013 9:58 am | by Mass Device | News | Comments

Covidien kicked off 2 new clinical trials this week to support a global evaluation of its Stellarex drug-coated angioplasty balloon. The Massachusetts-based company started enrolling patients with peripheral arterial disease in the Pivotal and PK arms of its larger ILLUMENATE clinical trials examining the safety and effectiveness of Covidien's Stellarex devices.

Researchers Step Closer to Custom-Building New Blood Vessels

July 17, 2013 9:40 am | by Shawna Williams, Johns Hopkins Medicine | News | Comments

Researchers at Johns Hopkins have coaxed stem cells into forming networks of new blood vessels in the laboratory, then successfully transplanted them into mice. The stem cells are made by reprogramming ordinary cells, so the new technique could potentially be used to make blood vessels genetically matched to individual patients and unlikely to be rejected by their immune systems, the investigators say.

A Safer, Longer-Lasting Approach to "Vascular Graft" Procedure

July 17, 2013 4:05 am | by PR Newswire | News | Comments

A team of physicians at DMC Harper University Hospital announced yesterday that it has successfully treated several patients with a new high-tech "vascular graft" that significantly reduces the risk of trauma to blood vessels used in connecting patients to the kidney dialysis machines that are essential to protecting their health.

Edwards Lifesciences goes after another set of Medtronic patents

July 16, 2013 1:35 pm | by Mass Device | News | Comments

Edwards Lifesciences wants a federal judge to rule that a pair of patents owned by arch-rival Medtronic are invalid because they aren't specific enough. The patents cover nerve stimulation technology. Edwards and Medtronic have spent considerable time in courts around the world, each arguing that the other's transcatheter aortic valve implant infringes various patents.

Step Forward in Understanding Arterial Disease

July 16, 2013 10:05 am | by University of Lincoln | News | Comments

The next step has been made into isolating the origin of cells linked to the progressive disorder Pulmonary Arterial Hypertension. Further strides have been made into isolating the origin of cells that could lead to a greater understanding of what goes into the development of our blood circulating systems.

Welch Allyn Introduces Two Connectivity-Ready Electrocardiograph Devices

July 15, 2013 12:36 pm | by Welch Allyn | News | Comments

Welch Allyn, a leading medical diagnostic device company that specializes in helping clinicians improve patient outcomes, today announced the availability of two connectivity-ready electrocardiograph devices in the United States. The Welch Allyn CP 150™ offers flexible report formatting, intuitive design and functionality.

Sorin Group Signs Supply Agreement for Boston Scientific Lotus Valve System

July 15, 2013 12:00 pm | by Business Wire | News | Comments

Sorin Group, a global medical device company and a leader in the treatment of cardiovascular diseases, announced today the signing of a supply agreement for the manufacturing of certain components of the Lotus TM Aortic Valve System, Boston Scientific Corporation’s second-generation TAVR technology.

Stentys' new CE Mark indications expand its potential PCI footprint

July 15, 2013 10:29 am | by Mass Device | News | Comments

Regulators in Europe handed Stentys SA (EPA:STNT) expanded indications for its self-apposing stent, opening up new potential patient populations. The Stentys treatment for acute myocardial infarction can now be used in patients with trickier cases, such as those with tapered, dilated or very large vessels or those with bypass grafts.

Welch Allyn Introduces Two Connectivity-Ready Electrocardiograph Devices in the United States

July 15, 2013 9:00 am | by Business Wire | News | Comments

Welch Allyn, a leading medical diagnostic device company that specializes in helping clinicians improve patient outcomes, today announced the availability of two connectivity-ready electrocardiograph devices in the United States. The Welch Allyn CP 150™ offers flexible report formatting, intuitive design and functionality.

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