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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.

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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.

Gov’t Stops Study Seeking to Prevent Type of Stroke

May 14, 2013 11:34 am | by Lauran Neergaard, AP Medical Writer | News | Comments

The government has halted a study testing treatments for a brain condition that can cause strokes after early results suggested invasive therapies were riskier than previously thought. The condition involves a kind of tangle in the brain called an arteriovenous malformation, or AVM. Arteries and veins grow knotted together until eventually some of them burst, causing a bleeding stroke.

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.

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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...

A Material Argument: Ceramic Injection Molding

May 13, 2013 3:17 pm | by Dr. Rachael Ambury, Sales and Applications Engineer, Morgan Technical Ceramics. | Articles | Comments

Ceramic injection molded products are increasingly being used in the manufacture of innovative medical components and devices, thanks to the unique range of material and performance attributes. In this article, the material, its key features, and the growing range of applications for which it is suited are highlighted.

Why Medtech Startups Are Moving to Ireland

May 13, 2013 2:33 pm | by Eddie Goodwin, Manager, Boston Office, Enterprise Ireland | Blogs | Comments

It’s no secret that getting a medical device to market can be a lengthy, frustrating process. Facing the new medical device excise tax and lack of clarity from the FDA around regulatory policies, medtech startups are now starting to rethink launching in the U.S.

Extremely Low 90-Day Cardiac Device Infection Rates with TYRX Antibacterial Envelope Use

May 13, 2013 12:19 pm | by Kureczka/Martin Associates | News | Comments

Use of TYRX, Inc.'s AIGISRx Antibacterial Envelope reduced major infection rates by more than 90% in patients undergoing Cardiovascular Implantable Electronic Device (CIED) replacement procedures compared to similar high-risk cohorts, according to the CITADEL & CENTURION clinical study results presented on Saturday at the Late Breaking Clinical Trials session at Heart Rhythm 2013.

BioControl Medical Launches New Website to Deepen Patient, Family, Clinician Education on Its Investigational CardioFit® Therapy

May 13, 2013 11:47 am | by The Associated Press | News | Comments

YEHUD, Israel & NEW HOPE, Minn.--(BUSINESS WIRE)--May 13, 2013--BioControl Medical has unveiled a new corporate website that offers patients, family and clinicians a valuable educational resource on its CardioFit therapy for heart failure (HF), as well as the INOVATE-HF (INcrease Of VAgal TonE...

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Biventricular Pacing Reduces Symptoms and Improves Quality-of-Life

May 13, 2013 9:52 am | by Medtronic | News | Comments

Medtronic has announced new data demonstrating that simultaneously pacing the lower chambers of the heart, or biventricular (BiV) pacing with a cardiac resynchronization therapy (CRT) device, significantly improves heart failure symptoms and quality of life in a subset of heart failure patients.

Landmark Study Demonstrates Lower Rate of Inappropriate Shocks in Patients with Sorin Dual Chamber ICD Devices

May 11, 2013 10:00 am | by The Associated Press | News | Comments

DENVER--(BUSINESS WIRE)--May 11, 2013--Sorin Group (MIL:SRN), (Reuters Code: SORN.MI), a global medical company and a leader in the treatment of cardiovascular diseases, announced findings from the landmark OPTION study 1 demonstrating that patients with Sorin dual-chamber implantable cardioverter...

Data Show Medtronic-Exclusive LIA Software Detects Non-Medtronic Lead Issues at a Greater Rate Than Standard Impedance Monitoring

May 10, 2013 4:06 pm | by The Associated Press | News | Comments

MINNEAPOLIS and DENVER - May 10, 2013 - Data presented today at Heart Rhythm 2013, the Heart Rhythm Society's 34th Annual Scientific Sessions, show that Medtronic, Inc. (NYSE:MDT) Lead Integrity Alert (LIA) software detected pace/sense lead issues in non-Medtronic leads at a...

Nanostim Announces Preliminary Results from LEADLESS Study in Late-Breaking Clinical Trial at Heart Rhythm 2013

May 10, 2013 3:42 pm | by The Associated Press | News | Comments

SUNNYVALE, Calif.--(BUSINESS WIRE)--May 10, 2013--Nanostim, Inc., a privately-owned developer of miniaturized, leadless cardiac pacemakers (LCP), today announced preliminary results from its LEADLESS study during the late breaking clinical trial presentations at Heart Rhythm 2013, the Heart Rhythm...

Sorin Group Announces FDA Approval and U.S. Launch OF SMARTVIEW Remote Monitoring Solution for Patients with Implanted Cardiac Defibrillators

May 10, 2013 12:04 pm | by The Associated Press | News | Comments

DENVER--(BUSINESS WIRE)--May 10, 2013--Sorin Group (MIL:SRN), (Reuters Code: SORN.MI), a global medical company and a leader in the treatment of cardiovascular diseases, today announced it received FDA approval for and is beginning the U.S. launch of the SMARTVIEW™ remote monitoring solution for...

Medtronic Issues Statement on iPad Interference Study

May 10, 2013 11:02 am | by Medtronic | News | Comments

Medtronic's current internal analysis and testing shows iPad technology presents no risk of electromagnetic interference with Medtronic implantable cardiac rhythm devices when used per manufacturer's instructions. However, as a precaution, patients implanted with a pacemaker or ICD are advised to follow Apple and Medtronic labeling recommendations and maintain a distance of six inches between the iPad and implanted device.

Operating Without Interrupting Warfarin Reduces Risk of Bleeding After Cardiac Device Surgery

May 10, 2013 10:21 am | by University of Ottawa Heart Institute | News | Comments

A new Canadian study shows that operating without interrupting warfarin treatment at the time of cardiac device surgery is safe and markedly reduces the incidence of clinically significant hematomas compared to the current standard of care. The new findings were released today at Heart Rhythm 2013, the Heart Rhythm Society's 34th Annual Scientific Sessions.

Weaving Flexibility and Strength into Stent Design

May 9, 2013 3:05 pm | by Kasey Panetta, Managing Editor, ECN | Articles | Comments

Though traditional laser-cut stents made from nitinol are effective, the design trades flexibility for strength, which means the stents are at risk for fracture, crushing, and kinking. This is a particular issue when the stents are used with patients suffering from femoropopliteal or proximal popliteal artery disease.

St. Jude Medical Announces Results from Independent Analysis of Optim-Insulated Defibrillation Leads in Late-Breaking Clinical Trial Session at Heart Rhythm 2013

May 9, 2013 1:55 pm | by The Associated Press | News | Comments

ST. PAUL, Minn.--(BUSINESS WIRE)--May 9, 2013--St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced the Population Health Research Institute (PHRI), an academic health science research institute, has conducted a further independent analysis of data received from...

New Four-Year Data From Boston Scientific Demonstrated WATCHMAN Device Was Superior To Warfarin For Mortality And Primary Efficacy In Patients With Atrial Fibrillation In Long Term Follow-Up Of The PROTECT AF Trial

May 9, 2013 12:02 pm | by The Associated Press | News | Comments

Boston Scientific Corporation (NYSE: BSX) reports that the four-year follow-up data from the PROTECT AF clinical trial demonstrated the WATCHMAN@ Left Atrial Appendage (LAA) Closure device was statistically superior to warfarin for preventing cardiovascular death, all-cause stroke and systemic...

First Patient Enrolled in reMARQable Clinical Study Evaluating the Safety and Efficacy of Multi-Electrode nMARQ™ Pulmonary Vein Isolation System™ in the Treatment of Paroxysmal Atrial Fibrillation

May 9, 2013 9:49 am | by The Associated Press | News | Comments

DIAMOND BAR, Calif.--(BUSINESS WIRE)--May 9, 2013--Biosense Webster, Inc., a worldwide leader in the diagnosis and treatment of cardiac arrhythmias, today announced the first patient has been enrolled in the reMARQable clinical study. ReMARQable will assess the safety and efficacy of the use of...

From Wireless Age to Consumer Age

May 8, 2013 11:54 am | by Sean Fenske, Editor-in-Chief, MDT | Blogs | Comments

Wireless healthcare is upon us. Each day, it seems more devices and technology are becoming untethered or new capabilities are being added to wireless devices. No longer are the applications of wireless devices limited to patient monitoring, but rather an array of therapies are now available for treating patients at home or even on the go.

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