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St. Jude Medical Gains CE Mark Approval for MRI Labeling of its Quadra Allure MP Cardiac Resynchronization Therapy Pacemaker
ST. PAUL, Minn.--(Healthcare Sales & Marketing Network)--St. Jude Medical, Inc. (STJ), a global medical device company, today announced CE Mark approval for magnetic resonance (MR) conditional labeling for the companys Quadra Allure MP cardiac resynchron... Devices, Cardiology, Radiology, Regulatory St. Jude Medical, Quadra Allure MP, Cardiac Resynchronization Therapy, Pacemaker (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - November 7, 2016 Category: Pharmaceuticals Source Type: news

Report: St. Jude sold off older CRM devices after learning of battery issue
St. Jude Medical (NYSE:STJ) continued to distribute outdated pacemaker devices that were indicated in a recall due to battery faults, even after correcting the flaw and producing new units, according to a StarTribune report. The devices were recalled in 2015 over issues with batteries failing with little to no warning, an issue which resulted in 2 deaths, according to the report. Despite fixing the problem and producing new, updated units, St. Jude continued to distribute the older devices indicated in the recall for 17 months. Executives at St. Jude reportedly “moved as quickly as possible with the information they...
Source: Mass Device - November 2, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Assist Devices Cardiac Implants Cardiovascular Food & Drug Administration (FDA) Recalls St. Jude Medical Source Type: news

CRT May Help Infants Recover After Biventricular Heart Surgery CRT May Help Infants Recover After Biventricular Heart Surgery
Temporary cardiac resynchronization therapy can boost blood pressure in infants with wide-QRS intervals after surgery for some forms of congenital heart disease, suggests a small randomized study.Heartwire from Medscape (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - October 6, 2016 Category: Consumer Health News Tags: Cardiology News Source Type: news

Medtronic issues urgent field safety notice for select ICDs, CRTds
Medtronic (NYSE:MDT) issued an urgent field safety notice concerning issues with specific units of its Viva cardiac resynchronization therapy defibrillators and Evera implantable cardioverter defibrillators that could result in rapid battery depletion. The Fridley, Minn.-based company sent the notice on August 12 to healthcare professionals managing patients with the devices. The notice warned of issues with 78 specific Viva CTR-D and Evera ICDs related to a specific subset of circuit components which may have a low resistance path that could result in rapid battery depletion. Medtronic said that, based on its records, 53 ...
Source: Mass Device - September 29, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Assist Devices Cardiac Implants Cardiovascular Regulatory/Compliance Medtronic Source Type: news

MassDevice.com +5 | The top 5 medtech stories for September 22, 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. LivaNova launches next-gen ICD, CRT-Ds in US LivaNova said today it is launching its next-gen Platinium implantable cardiac defibrillators and cardiac resynchronization therapy devices in the U.S. The next-gen devices include i...
Source: Mass Device - September 22, 2016 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 5 Source Type: news

LivaNova launches next-gen ICD, CRT-Ds in US
LivaNova (NSDQ:LIVN) said today it is launching its next-gen Platinium implantable cardiac defibrillators and cardiac resynchronization therapy devices in the U.S. The next-gen devices include improved longevity and lower energy consumption, with service life projected over 14 years for single-chamber ICDs, 13 years for dual-chamber ICDs and 10 years for CRT-D devices, LivaNova said. “The technology we have developed will provide U.S. physicians and patients a broader range of devices offering the longest projected longevity of any on the market. Platinium addresses the medical community requests in closing the gap ...
Source: Mass Device - September 22, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Cardiac Assist Devices Cardiac Implants Cardiovascular LivaNova Source Type: news

EBR Systems wins FDA nod for wireless pacer trial
EBR Systems said today it won an investigational device exemption from the FDA for a clinical trial of its WiSE wireless cardiac resynchronization therapy device. The Sunnyvale, Calif.-based company claimed the device as the world’s only wireless, endocardial pacing system for stimulating the left ventricle. “WiSE is unique, significant technology that’s cleared for use in Europe and has proven very beneficial thus far. This important medical advance addresses major shortcomings in current [cardiac resynchronization therapy] implants and could dramatically improve success rates for heart failure patients...
Source: Mass Device - September 13, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Clinical Trials Food & Drug Administration (FDA) Regulatory/Compliance EBR Systems Inc. Source Type: news

Biotronik hits the market in Japan with Ilivia MRI-safe ICD
Biotronik said yesterday it launched its Ilivia magnetic resonance imaging-safe implantable cardioverter defibrillator in Japan. The Berlin-based comapny said the Ilivia device features both its ProMRI technology and its MRI AutoDetect feature which automatially recognizes when the user is in an MRI environment and switches to MRI mode. The device then switches back to normal functionality when MRI fields are no longer detected. “It’s only recently that MRI conditional devices have become the gold standard in CIEDs. These devices have seen continuous improvements, with the latest being the MRI AutoDetect function i...
Source: Mass Device - September 6, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Cardiac Implants Cardiovascular Biotronik Source Type: news

Medtronic Technologies Improve Delivery of Cardiac Resynchronization Therapy
Medtronic plc (NYSE:MDT) today announced results from the Cardiac Resynchronization Therapy Efficacy Enhancement (CRTee) study. The study showed that the Medtronic-exclusive device-based EffectivCRT ™ during AF algorithm improves therapy delivery in heart failure patients with atrial fibrillation (AF). The results were presented at the 2016 European Society of Cardiology (ESC) Congress in Rome. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - September 3, 2016 Category: Cardiology Source Type: news

Researchers: Short-seller ’ s claims about St. Jude Medical devices have ‘ major flaws ’
A short-seller’s report that cardiac rhythm management devices made by STJ are vulnerable to hackers has “major flaws” and doesn’t prove its allegations, according to researchers from the University of Michigan. Muddy Waters, the firm founded by well-known short-seller Carson Block, last week aimed to disrupt the pending, $25 billion acquisition of St. Jude by Abbott (NYSE:ABT); in addition to his bet that STJ share prices will fall, Block is long on ABT shares. His shop and a startup cybersecurity business called MedSec alleged last week that St. Jude’s implanted cardiac rhythm management de...
Source: Mass Device - August 30, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiovascular Legal News Wall Street Beat St. Jude Medical Source Type: news

Medtronic to cover HeartWare ’ s cash burn by cutting back on other heart failure R & D
Medtronic (NYSE:MDT), which earlier this week closed on the $1.1 billion buyout of implantable cardiac pump maker HeartWare, plans to cover HeartWare’s cash burn by cutting other heart failure R&D programs, the company executives said yesterday. HeartWare’s implantable left ventricular assist devices are designed for end-stage heart failure patients, either as a destination therapy until death or as a bridge to heart transplantation. “[W]e had a number of investments internally going on in R&D programs directed specifically at heart failure, including diagnostic programs and services, as well as enh...
Source: Mass Device - August 26, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiovascular MassDevice Earnings Roundup Mergers & Acquisitions Research & Development Wall Street Beat HeartWare International Inc. Medtronic Source Type: news

FDA approves St. Jude Medical’s SyncAV CRT software
St. Jude Medical (NYSE:STJ) said today that the FDA approve its SyncAV cardiac resynchronization therapy software, which is designed to automatically adjust pacing based on real-time changes in a patient’s cardiac condition. The new software is designed to work with or independently of St. Jude’s multi-point pacing technology, which allows physicians to tailor pacing therapy by controlling multiple pulses to the left ventricle for each heartbeat. “St. Jude Medical has a proven dedication to continued leadership in heart failure management to help physicians manage some of their most complex patients. ...
Source: Mass Device - July 11, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiovascular Food & Drug Administration (FDA) Regulatory/Compliance Cardiac Rhythm Management St. Jude Medical Source Type: news

MassDevice.com +5 | The top 5 medtech stories for July 1, 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. Nestle poaches Fresenius CEO Schneider Nestle lured the CEO of Fresenius, Ulf Mark Schneider, to the corner office this week. Fresenius promoted CFO Stephan Sturm to replace Schneider. Read more 4. Biotronik wins...
Source: Mass Device - July 1, 2016 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 5 Source Type: news

Biotronik wins CE Mark for Edora MRI-adaptable pacers
Biotronik said today that it won CE Mark approval in the European Union for its Edora line of MRI-adaptable pacers. The German medical device company said the Edora pacemakers and cardiac resynchronization therapy pacemakers use a sensor called MRI AutoDetect that’s designed to ensure that the device goes into safe mode only during magnetic resonance scans, ensuring that the device continues to deliver therapy for as long as 14 days after the sensor is activated. Once the scan is over, the Edora device automatically resumes therapy without needing to be reset by a physician, Biotronik said. “The MRI AutoDete...
Source: Mass Device - July 1, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiovascular Imaging Regulatory/Compliance Biotronik Cardiac Rhythm Management Source Type: news

MassDevice.com +5 | The top 5 medtech stories for June 28, 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. Sweden’s Handicare acquires mobility device developer Prism Medical Prism Medical said today that mobility and technical aid developer Handicare agreed to acquire it for approximately $62 million. Swedish Handicare, which sup...
Source: Mass Device - June 28, 2016 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 5 Source Type: news