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Biosensors Receives CE Mark Approval for BioMatrix NeoFlex

May 20, 2013 10:54 am | by Biosensors International | News | Comments

BioMatrix NeoFlex features a new advanced stent delivery system, improving pushability, trackability, and crossability. It also has a lower lesion entry profile than its predecessor. BioMatrix NeoFlex retains the same combination of abluminal biodegradable polymer coating, proprietary limus drug Biolimus A9, and platform that has made the BioMatrix stent family an increasingly popular choice of DES in global markets where available.

CardioDx Announces Publication of the IMPACT-CARD Trial Demonstrating Use of Corus@ CAD Test Influenced Cardiologists' Clinical Management of Patients with Symptoms Suggestive of Obstructive Coronary Artery Disease

May 20, 2013 8:31 am | by The Associated Press | News | Comments

CardioDx, Inc., a pioneer in the field of cardiovascular genomic diagnostics, today announced the publication of the IMPACT-CARD (Investigation of a Molecular Personalized Coronary Gene Expression Test on Cardiology Practice Pattern) trial in Critical Pathways in Cardiology. This prospective...

Medtronic Receives 'CE' Mark for 'Export Advance' Aspiration Catheter

May 20, 2013 7:06 am | by The Associated Press | News | Comments

Expanding its portfolio of medical technology for the interventional treatment of cardiovascular disease, Medtronic, Inc. (NYSE: MDT) announced today that the Export Advance aspiration catheter recently received the CE (Conformité Européenne) mark and will soon be launched in Europe and other international markets.


OrbusNeich's GenousT Stent Associated With Lower Restenosis Rate Compared to Bare Metal Stents in Low-Risk Non-ST-Segment Elevation Acute Coronary Syndrome (NSTE-ACS) Patients

May 20, 2013 5:00 am | by The Associated Press | News | Comments

OrbusNeich today announced that the company's Genous Stent is associated with a significantly lower rate of binary restenosis compared to bare metal stents (BMS) in low-risk non-ST-segment elevation acute coronary syndrome (NSTE-ACS) patients at six months. Data from JACK-EPC, an...

Claret Medical, Inc. Announces Publication of the First Clinical Research on the Frequency and Composition of Embolic Debris Captured during TAVR

May 19, 2013 1:43 pm | by Bio-Medicine.Org | News | Comments

SANTA ROSA, Calif. , May 20, 2013 /- Claret Medical, Inc. announced the publication of an original manuscript by Dr. Nicolas Van Mieghem et al., Histopathology of Embolic Debris Captured During Transcatheter Aortic Valve Replacement . Published ahead of print in Circulation, May 7 th this research is the result of a collaboration between Erasmus Medical Center, Rotterdam,

Statistical Challenges in Medical Device Trail Evaluation

May 17, 2013 4:30 pm | by The Associated Press | News | Comments

Medical devices are any medical items that are neither a drug nor a biological product. In light of their different mechanisms, actions and regulatory requirements, medical device (MD) trail evaluations are much more complicated than drug trails due to their unique clinical practices....

Alumina Substrate and Medical Equipment Resistors

May 17, 2013 4:13 pm | by Michael West, Director of Engineering, Ohmite Manufacturing | Articles | Comments

This article will walk through the various characteristics of these resistors, including high resistance values, high voltage handling, small size, resiliency, and more, to demonstrate how they might aid in the design of medical devices.

Security Risks Found in Sensors for Heart Devices

May 17, 2013 12:13 pm | by University of Michigan | News | Comments

The type of sensors that pick up the rhythm of a beating heart in implanted cardiac defibrillators and pacemakers are vulnerable to tampering, according to a new study conducted in controlled laboratory conditions. Implantable defibrillators monitor the heart for irregular beating and, when necessary, administer an electric shock to bring it back into normal rhythm.


Diagnosing Heart Attacks: There's an App for That

May 17, 2013 11:42 am | by American Heart Association | News | Comments

An experimental, inexpensive iPhone application transmitted diagnostic heart images faster and more reliably than emailing photo images, according to a research study presented at the American Heart Association's Quality of Care and Outcomes Research Scientific Sessions 2013.

CardioDx Announces New Data Demonstrating Use of Corus® CAD in the Primary Care Setting for Evaluation of Symptomatic Patients with Suspected CAD Influences Clinical Decision Making

May 17, 2013 11:00 am | by PR Newswire | News | Comments

PALO ALTO, Calif., May 17, 2013 /PRNewswire/ -- CardioDx, Inc., a pioneer in the field of cardiovascular genomic diagnostics, today announced results of a clinical utility study of the Corus® CAD gene expression test in the real-world primary care setting for evaluating patients with...

Thoratec Announces FDA Approval Of HeartMate II Pocket Controller

May 17, 2013 8:00 am | by PR Newswire | News | Comments

PLEASANTON, Calif., May 17, 2013 /PRNewswire/ -- Thoratec Corporation (NASDAQ: THOR), a world leader in device-based mechanical circulatory support therapies to save, support and restore failing hearts, today announced that it has received approval from the U.S. Food and Drug...

Valtech Cardio Treats First Mitral Regurgitation Patients with Percutaneous Annuloplasty Device Without Open-Heart Surgery

May 16, 2013 2:14 pm | by PR Newswire | News | Comments

Valtech Cardio Ltd., a medical device company that develops solutions for mitral valve repair and replacement, announced today that two patients diagnosed with severe mitral regurgitation (MR) have been treated successfully with the Transfemoral Cardioband™ Annuloplasty System.

Tryton Medical Announces CE Mark and European Launch of Next-Generation Tryton Side Branch SHORT Stent

May 16, 2013 10:03 am | by Tryton Medical | News | Comments

Tryton Medical, Inc., the leading developer of stents designed to treat bifurcation lesions, today announced that the company received the CE Mark for the Tryton Side Branch SHORT Stent, a novel coronary stent system that broadens the treatment options in bifurcations in large vessels with a short main branch landing zone.


Stanford Engineers Monitor Heart Health Using Paper-Thin Flexible 'Skin'

May 16, 2013 9:59 am | by Thomas Sumner, Stanford News Service | News | Comments

Engineers combine layers of flexible materials into pressure sensors to create a wearable heart monitor thinner than a dollar bill. The skin-like device could one day provide doctors with a safer way to check the condition of a patient's heart.

SynCardia Co-Founder Honored with Pioneer in Transplantation Award at ISHLT

May 16, 2013 9:10 am | by The Associated Press | News | Comments

SynCardia Systems, Inc. (, manufacturer of the world's first and only FDA, Health Canada and CE (Europe) approved Total Artificial Heart, announced today that world-renowned heart surgeon and SynCardia co-founder Jack G. Copeland, MD, was awarded the prestigious Pioneer in...

St. Jude Medical Announces European Approval of 3-D Vessel Reconstruction Technology to Aid Physicians in Stent Placement

May 16, 2013 8:01 am | by The Associated Press | News | Comments

ST. PAUL, Minn.--(BUSINESS WIRE)--May 16, 2013--St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced CE Mark approval of its ILUMIEN ™ OPTIS ™ PCI Optimization System ™, a new technology designed to provide physicians with a comprehensive disease assessment tool for...

Changing the Status Quo for Implantable Devices

May 15, 2013 3:15 pm | by Derek Smith, Chief Commercial Officer, GHX | Blogs | Comments

On average, implantable devices account for 30 percent of total hospital supply spend, and make up 50 to 80 percent of the total cost for some procedures. Despite these large numbers, processes around managing and tracking these devices are rife with inefficiencies and revenue leakage.

CircuLite® Receives Approval to Begin CE Mark Trial for SYNERGY® IC Circulatory Support System

May 15, 2013 12:18 pm | by The Associated Press | News | Comments

TEANECK, N.J.--(BUSINESS WIRE)--May 15, 2013--CircuLite®, Inc. today announced that it has received approval from the Federal Agency for Medicines and Health Products in Belgium to commence the CE Mark trial of the SYNERGY® IC Circulatory Support System, the first mechanical support system that...

Body Fat Hardens Arteries After Middle Age

May 15, 2013 11:32 am | by Sam Wong, Imperial College London | News | Comments

Having too much body fat makes arteries become stiff after middle age, a new study has revealed. In young people, blood vessels appear to be able to compensate for the effects of obesity. But after middle age, this adaptability is lost, and arteries become progressively stiffer as body fat rises – potentially increasing the risk of dying from cardiovascular disease.

Engineered Biomaterial Could Improve Success of Medical Implants

May 15, 2013 10:22 am | by Michelle Ma, University of Washington | News | Comments

It’s a familiar scenario – a patient receives a medical implant and days later, the body attacks the artificial valve or device, causing complications to an already compromised system. Expensive, state-of-the-art medical devices and surgeries often are thwarted by the body’s natural response to attack something in the tissue that appears foreign.

Elixir Medical Receives CE Mark Approval for the Fully Bioresorbable DESolve® Novolimus Eluting Coronary Scaffold System

May 15, 2013 7:00 am | by The Associated Press | News | Comments

SUNNYVALE, Calif.--(BUSINESS WIRE)--May 15, 2013--Elixir Medical Corporation, a developer of product platforms that combine state-of-the-art medical devices with advanced pharmaceuticals, announced that it has received CE (Conformité Européenne) Mark approval for its DESolve ® Novolimus Eluting...

Southern Denmark Tackles Heart Disease with IBM Big Data Analytics Program

May 15, 2013 5:35 am | by IBM | News | Comments

IBM announced today that the Region of Southern Denmark is launching a new program to provide comprehensive insight to improve the quality and comprehensiveness of care for patients with chronic illness. The goal of the program is to facilitate real-time communication among patients, physicians, pharmacists, mental health professionals and specialists so all parties have insight into patient care plans.

How Can Advanced Imaging Studies Enhance Diabetes Management?

May 14, 2013 10:31 am | by Diabetes Technology & Therapeutics | News | Comments

New approaches to applying noninvasive imaging tests such as computed tomography, magnetic resonance, and positron emission tomography may play a bigger role in evaluating and managing patients with diabetes. Advances in noninvasive imaging technology can assess important changes in fat composition and distribution in the body that may affect the metabolic complications and diseases associated with diabetes.

UGA Researchers Develop Synthetic HDL Cholesterol Nanoparticles

May 14, 2013 10:28 am | by Alan Flurry, Franklin College of Arts and Sciences | News | Comments

Atherosclerosis, a buildup of cellular plaque in the arteries, remains one of the leading causes of death globally. While high-density lipoprotein, or HDL, the so-called good cholesterol, is transferred to the liver for processing, low-density lipoprotein, or LDL, builds up in the arteries in the form of plaque.

St. Jude Medical Announces First Patient Enrollment in EnligHTN III Renal Denervation Study of Next-Generation EnligHTN System

May 14, 2013 8:00 am | by The Associated Press | News | Comments

ST. PAUL, Minn.--(BUSINESS WIRE)--May 14, 2013--St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced enrollment of the first patient in the EnligHTN III trial. This study will evaluate the safety and performance of the new second-generation EnligHTN ™ Renal...

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