Cardiac Resynchronization Therapy News This is an RSS file. You can use it to subscribe to this data in your favourite RSS reader or to display this data on your own website or blog.

FDA clears Medtronic’s Tyrx envelope for DBS devices
Medtronic (NYSE:MDT) said today that it’s launching its Tyrx surgical envelope in the U.S. for use with deep-brain stimulation devices, after it won 510(k) clearance from the FDA for use of the infection-fighting envelope with implantable neurostimulators. Fridley, Minn.-based Medtronic said it’s planning to make the Tyrx device, acquired for $160 million in January 2014, available for other neurostim indications “in the coming months.” The device is designed to elute a pair of anti-microbial drugs, minocycline and rifampin, for 7 days. The envelope is designed to then dissolve over a period of r...
Source: Mass Device - October 8, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiovascular Food & Drug Administration (FDA) Neuromodulation/Neurostimulation Regulatory/Compliance Surgical Medtronic TYRX Inc. Source Type: news

EBR Systems wins CE Mark for wireless pacer
EBR Systems said Monday it won CE Mark approval in the European Union for its WiSE wireless endocardial cardiac resynchronization therapy device. The EBR device uses a subcutaneous generator to wirelessly deliver ultrasound energy to a “pellet” implanted on the inside of the heart, in the right ventricle, which it uses to synchronize the left and right ventricles. “A growing body of evidence strongly suggests EBR’s WiSE Technology can benefit patients who have failed conventional cardiac resynchronization implants. We look forward to working with leaders in the European clinical community to further cha...
Source: Mass Device - October 7, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Assist Devices Cardiac Implants Cardiovascular Regulatory/Compliance EBR Systems Inc. Source Type: news

EBR Systems Receives CE Mark For World's First Wireless Cardiac Pacing System For Heart Failure
EBR Systems, Inc., leading innovator in wireless heart stimulation, today announced European CE Mark (Conformité Européenne) approval for itsWiSE(WirelessStimulationEndocardially) Technology.EBR Systems’ WiSE Technology is the world’s only wireless endocardial pacing system for cardiac resynchronization therapy (CRT). (Source: Medical Design Online News)
Source: Medical Design Online News - October 5, 2015 Category: Medical Equipment Source Type: news

CRT's Obesity Paradox in HF: Long-Term Survival Rises With BMICRT's Obesity Paradox in HF: Long-Term Survival Rises With BMI
Widely recognized but poorly understood, the inverse relationship between heart failure mortality and BMI applies to patients on cardiac resynchronization therapy and may extend at least a decade. Heartwire from Medscape (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - October 1, 2015 Category: Consumer Health News Tags: Cardiology News Source Type: news

MassDevice.com +3 | The top 3 medtech stories for August 25, 2015
Say hello to MassDevice +3, a bite-sized view of the top three medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 3 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry. 3. Boston Scientific adds MR-safe label to some EU defibs Boston Scientific said yesterday that it added MR-conditional labeling to the CE Mark for some of the defibrillators it sells in the European Union, claiming the title for Europe’s largest portfolio of MRI-compatible devices. Marlborough...
Source: Mass Device - August 25, 2015 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 3 Source Type: news

Boston Scientific adds MR-safe label to some EU defibs
Boston Scientific (NYSE:BSX) said yesterday that it added MR-conditional labeling to the CE Mark for some of the defibrillators it sells in the European Union, claiming the title for Europe’s largest portfolio of MRI-compatible devices. Marlborough, Mass.-based Boston Scientific said its EL extended longevity and Mini implantable cardiac defibrillators and the X4 cardiac resynchronization therapy defibrillators are now cleared to be labeled with the “ImageReady” brand. The company said the news means that nearly all of its high-voltage cardiac rhythm management devices and leads have MR-conditional ...
Source: Mass Device - August 25, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiovascular Regulatory/Compliance Boston Scientific Cardiac Rhythm Management CE Mark Source Type: news

Boston Scientific Announces CE Mark For MRI Compatible Labeling For ICD And CRT-D Systems
Boston Scientific Corporation (NYSE:BSX) has received CE Mark on magnetic resonance imaging (MRI) conditional labeling for the current family of EL (Extended Longevity) and MINI implantable cardioverter defibrillator (ICD) and the X4 cardiac resynchronization therapy defibrillator (CRT-D) systems. This revised labeling ensures that future patients and those already implanted with these systems are able to undergo MRI scans if indicated. (Source: Medical Design Online News)
Source: Medical Design Online News - August 25, 2015 Category: Medical Equipment Source Type: news

Biotronik launches 2 new studies
Biotronik announced 2 new studies last week that are slated to examine the company’s CRT-D device and BioMonitor implanted cardiac monitor. A 277-patient BioContinue clinical trial will examine the risk of ventricular arrhythmias after CRT-D replacement, enrolling patients over 2 years at 40 centers across 8 countries, the company said. Biotronik said the trial will be the 1st to investigate defibrillator back-up following device placement in heart failure patients with a primary indication for cardiac resynchronization therapy defibrillators. Patients in the trial will be implanted with Biotronik’s CRT-Ds and ...
Source: Mass Device - August 12, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Assist Devices Cardiac Implants Cardiovascular Clinical Trials Research & Development Biotronik Source Type: news

Sorin claims its new CRT-P is the world’s smallest
Sorin Group (BIT:SRN) said today it launched its Reply CRT-P cardiac resynchronization therapy pacemaker, claiming it to be the world’s smallest of its kind. The Reply CRT-P is 11.3 cc in volume, 3.7 cc smaller than Boston Scientific‘s (NYSE:BSX) Intua and 0.2 cc smaller than St. Jude Medical‘s (NYSE:STJ) Anthem CRT-P, according to their respective sites. The device also features the ability to adapt to heart rate due to exercise and avoid inappropriate reactions, Sorin said. The 1st device was implanted at the Papworth Hospital in Cambridge, UK by Dr. Brian Gordon, Sorin said. “The small size of...
Source: Mass Device - July 31, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Assist Devices Cardiac Implants Cardiovascular Surgical Sorin Group Source Type: news

Medtronic wants $6m for legal fees in Mirowski spat
Medtronic (NYSE:MDT) asked a federal court for a $6 million award to cover its legal costs in the long-running battle with Mirowski Family Ventures involving patents licensed to Boston Scientific (NYSE:BSX). A federal judge in Delaware ruled in June that MFV must cover legal costs in the case, which made it all the way to the U.S. Supreme Court last year. Judge Susan Robinson of the U.S. District Court for Delaware ruled that MFV must cover the legal costs in the case, according to court documents. Last week Medtronic asked Robinson to award more than $6 million in fees, “reflecting the amounts paid by Medtron...
Source: Mass Device - July 22, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiovascular Legal News Cardiac Rhythm Management medtronic Mirowski Family Ventures Source Type: news

Biotronik launches CRT in women study
Biotronik said last week it enrolled the 1st patient in its Biowomen study investigating the difference in cardiac resynchronization therapy response in men and women to understand if women respond better to the treatment. The trial seeks to enroll 247 patients of each gender over 2 years, with a 1-year follow-up and results expected in 2018, the Berlin, Germany-based medical device company said. “We understand that ideal treatment for [heart failure] patients can vary based on age, sex and medical factors, and the best way to understand the patient population is with clinical investigations. Through Biowomen we h...
Source: Mass Device - July 7, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Clinical Trials Women's Health Biotronik Source Type: news

Biotronik launches Itrevia MRI-safe quad CRT-D in Japan
Biotronik said today that it launched its Itrevia MRI-safe quad cardiac resynchronization therapy defibrillator in Japan, part of a Japanese rollout of new devices for 2015. The device is equipped with home monitoring connectivity, as well as compatibility with up to 1.5 tesla MRI machines, the German medical device giant said. “As a producer of superior medical technologies, it is imperative for us to have a presence in the world’s leading technologies market. It also makes sense that the world’s biggest producer of ProMRI technology should have a strong presence in the country where MRI scanning is the...
Source: Mass Device - July 2, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Assist Devices Cardiac Implants Cardiovascular Surgical Biotronik Source Type: news

Data Show Medtronic Quadripolar CRT Technology Optimizes Treatment For Heart Failure Patients
Medtronic plc recently announced study results demonstrating that its quadripolar cardiac resynchronization therapy (CRT) system gives physicians more options to optimize CRT delivery, which may improve heart failure patients' response to the therapy. (Source: Medical Design Online News)
Source: Medical Design Online News - May 19, 2015 Category: Medical Equipment Source Type: news

Consumer Information on: Myopore Sutureless Myocardial Pacing Lead - P130012
The Greatbatch Myopore Sutureless Myocardial Pacing Lead is a surgically implanted, insulated, and sutureless wire with a screw-in tip that is part of a permanently implanted pacemaker, defibrillator, or cardiac resynchronization therapy (CRT) device. (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - May 8, 2015 Category: Medical Equipment Source Type: news

Consumer Information on: Model 5071 Lead - P120017
The Medtronic Model 5071 Lead is a surgically implanted, insulated, and sutureless wire with a screw-in tip that is part of a permanently implanted pacemaker, defibrillator, or cardiac resynchronization therapy (CRT) device. (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - May 8, 2015 Category: Medical Equipment Source Type: news