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Boston Scientific touts U.K. nod for EnduraLife batteries
Boston Scientific (NYSE:BSX) said yesterday that a U.K. healthcare agency backed its EnduraLife batteries for cardiac resynchronization therapy defibrillators, citing the savings offering by reduced replacement procedures. The guidance from Great Britain’s National Institute for Health & Care Excellence concluded that the EnduraLife technology would improve outcomes and create some $7.4 million (£6 million) in savings over 5 years, Boston Scientific said. The NICE evaluation calculated that avoiding early replacement procedures would pare costs such as hospital admissions, bed days and procurement costs and ...
Source: Mass Device - March 17, 2017 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiovascular Wall Street Beat ACC 2017 Boston Scientific Cardiac Rhythm Management Source Type: news

New Analysis of Reverse Trial Shows Medtronic CRT Devices Cost-Effective, While Helping Patients with Mild Heart Failure Live Longer
Medtronic plc (NYSE:MDT) today announced an economic analysis of five-year data showing that patients with mild heart failure who get cardiac resynchronization therapy (CRT) devices early in their treatment live longer and that implanting these devices is cost-effective, compared to optimal medical therapy. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - March 6, 2017 Category: Cardiology Source Type: news

Medtronic touts 5-year economic analysis data from CRT-focused Reverse study
Medtronic (NYSE:MDT) today released 5-year economic analysis data from its Reverse study of patients treated with cardiac resynchronization therapy devices, touting longer lifespans and long-term cost efficiency compared to optimal medical therapy. Results from the Reverse trial were published in the Journal of the American College of Cardiology: Heart Failure. “These new data expand upon the current evidence and guidelines for the treatment of heart failure, by showing that CRT in patients with mildly symptomatic heart failure is beneficial, both from a clinical perspective, as well as from a financial perspective. ...
Source: Mass Device - February 27, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Assist Devices Cardiovascular Clinical Trials Medtronic Source Type: news

MassDevice.com +5 | The top 5 medtech stories for February 24, 2017
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 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. Get this in your inbox everyday by subscribing to our newsletters. 5. FDA panel supports Claret Medical’s Sentinel, despite efficacy questions The FDA’s Circulatory System Devices Panel this week gave its support to de novo clearance for Claret Medical’s Sentinel embolic protection dev...
Source: Mass Device - February 24, 2017 Category: Medical Equipment Authors: Brad Perriello Tags: News Well Plus 5 Source Type: news

Medtronic lands CE Mark for quad MRI-safe pacers
Medtronic (NYSE:MDT) said today that it won CE Mark approval in the European Union for its line of quadripolar, MRI-safe cardiac resynchronization therapy pacemakers. The approval covers Medtronic’s Percepta, Serena and Solara devices, the Fridley, Minn.-based company said. The devices are slated to the hit the European market in March. “With the addition of quadripolar CRT-P devices to our heart failure portfolio, we now offer a comprehensive line of CRT devices to further meet the needs of patients throughout Europe,” heart failure GM Dr. David Steinhaus said in prepared remarks. “Our new quadr...
Source: Mass Device - February 24, 2017 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiovascular Imaging Regulatory/Compliance Medtronic Source Type: news

FDA clears Biotronik ’ s Pro-Kinetic Energy cobalt chromium stent
Biotronik said today it won FDA approval for its Pro-Kinetic Energy cobalt chromium coronary stent system, with indication for use in patients with arterial blockages between 2.25 and 4mm in diameter and lesion length up to 31 mm. The Pro-Kinetic Energy stent system is designed to imProve coronary luminal diameter in patients with new or recurring blockages in the coronary arteries. The Berlin, Germany-based company said FDA apProval of the device based off of results from its Biohelix-I clinical study. “We’re proud to make the Pro-Kinetic Energy stent available to physicians and their patients in the US. It i...
Source: Mass Device - February 15, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Cardiovascular Food & Drug Administration (FDA) Regulatory/Compliance Stents Biotronik Source Type: news

VisCardia closes $13m Series B, picks up Inovise Medical assets & tech
Novel heart failure device developer VisCardia said yesterday it closed a $12.5 Series B financing round and picked up the Inovise Medical’s assets and technology rights. Technology and assets from Inovise will support the continued development of VisCardia’s proprietary implantable heart failure therapy device, the Portland, Ore.-based company said. VisCardia’s implantable heart failure system is designed to stimulate the thoracic cavity musculature to mechanically augment cardiac systole and diastolic filling for heart failure patients with reduced ejection fraction and normal ventricular electrical con...
Source: Mass Device - February 2, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Cardiac Implants Cardiovascular Mergers & Acquisitions VisCardia Source Type: news

Biotronik receives FDA warning on Berlin plant; launches Ilivia CRT-Ds
The FDA this week released a warning letter it sent to Biotronik over issues it identified during an inspection of its facilities in Berlin, shortly after the company announced the launch of its Ilivia cardiac resynchronization therapy devices. In the letter, the federal watchdog referenced 6 specific violations and warned that “given the serious nature of the violations” that the agency was “taking steps to refuse entry of the devices into the United States.” The 1st noted violation was a failure to ensure that processes which cannot be fully verified by subsequent inspections and tests are vali...
Source: Mass Device - February 1, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Assist Devices Cardiac Implants Cardiovascular Food & Drug Administration (FDA) Regulatory/Compliance Biotronik Source Type: news

Defibrillator Only or CRT-D? It Depends, Even When Both Indicated Defibrillator Only or CRT-D? It Depends, Even When Both Indicated
Whether patients eligible for cardiac resynchronization therapy actually get it with an ICD can depend on certain clinical features, type of insurance, and the operator ' s volume and certification.Heartwire from Medscape (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - January 27, 2017 Category: Consumer Health News Tags: Cardiology News Source Type: news

MassDevice.com +5 | The top 5 medtech stories for November 14, 2016
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 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. Get this in your inbox everyday by subscribing to our newsletters. 5. Final FDA rules clarify adverse event reporting for contract manufacturers The FDA last week issued final guidance for medical device companies on the requirements for reporting adverse events that walked back much of the burde...
Source: Mass Device - November 14, 2016 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 5 Source Type: news

FDA approves Medtronic ’ s Claria MRI quad CRT-D
Medtronic (NYSE:MDT) said today that it won pre-market approval from the FDA for its Claria MRI quad cardiac resynchronization therapy defibrillator for magnetic resonance imaging scans at both 1.5 and 3 Tesla. “The Claria MRI CRT-D is our latest innovation to help improve patients’ response to CRT, establishing a new level of personalized care,” heart failure GM Dr. David Steinhaus said in prepared remarks. “And it further expands our industry-leading MR-conditional portfolio of devices, which are helping to improve the lives of more patients throughout the world.” “Until now, CRT dev...
Source: Mass Device - November 14, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiovascular Food & Drug Administration (FDA) Regulatory/Compliance Cardiac Rhythm Management Medtronic Source Type: news

Boston Scientific launches Dakota nitinol kidney stone retrieval device
Boston Scientific (NYSE:BSX) said today it launched its Dakota nitinol retrieval device designed for kidney stone retrieval in the U.S. and Europe. The Dakota stone retrieval device is designed to work with kidney stones of multiple sizes, ranging from 1 mm to 10 mm, Marlborough, Mass.-based Boston Scientific. “The Dakota Retrieval Device with OpenSure Handle offers innovative technology that helps me solve some of the challenges faced during ureteroscopy procedures. I can extract a variety of stone sizes and compositions and make multiple passes during one procedure to help patients become stone free,” Dr. Ro...
Source: Mass Device - November 8, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Urology Boston Scientific Source Type: news

MassDevice.com +5 | The top 5 medtech stories for November 7, 2016
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 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. Get this in your inbox everyday by subscribing to our newsletters. 5. First patient receives Pixium bionic vision implant Pixium Vision said today that the 1st patient in the UK was implanted with its IRIS II bionic vision system. The epi-retinal implant has 150 electrodes and a bio-inspired came...
Source: Mass Device - November 7, 2016 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 5 Source Type: news

St. Jude wins CE Mark for MRI safe labeling for Quadra CRT-P
St. Jude Medical (NYSE:STJ) said today it won CE Mark approval in the European Union to add magnetic resonance imaging conditional labeling to its Quadra Allure MP cardiac resynchonization therapy pacemaker. The company’s Quadra Allure MP CRT-P is now cleared as operable with diagnostic MRI scans of up to 1.5 Tesla, the St. Paul, Minn.-based company said. “The Quadra Allure MP is the only CRT-P with MultiPoint Pacing technology, MRI full-body labeling, and more clinical options to treat patients who don’t respond to initial pacing therapy. This new technology allows patients who have heart failure that is c...
Source: Mass Device - November 7, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Assist Devices Cardiac Implants Cardiovascular Regulatory/Compliance St. Jude Medical Source Type: news

Boston Scientific, University of Alabama settle CRM patent spat
Boston Scientific (NYSE:BSX) and the University of Alabama settled a patent dispute over cardiac rhythm management technology. The spat spans back to 2014, when the University of Alabama at Birmingham and the UAB Research Foundation filed a lawsuit against Boston Scientific and Cardiac Pacemakers, saying that the companies infringed on its patent by making, using, offering and selling cardiac resynchronization therapy defibrillators. The suit was stayed in August 2015 while Boston Scientific pursued inter partes review with the U.S. Patent & Trademark office, Boston Scientific said last week in a regulatory filing. Th...
Source: Mass Device - November 7, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Legal News Patent Infringement Boston Scientific Cardiac Rhythm Management Source Type: news