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Medtronic wins FDA nod for Azure remote monitoring equipped pacers
Medtronic (NYSE:MDT) said today it won FDA approval for its portfolio of Azure pacemakers with BlueSync patient monitoring technology. The clearances cover both the Azure XT MRI and Azure S MRI pacers including single chamber and dual chamber models, the Fridley, Minn.-based company said. The newly cleared pacers have estimated lifespans of 13.7 years for dual chamber pacers, which Medtronic estimates is 27% longer than the earlier-gen devices. The Azure portfolio of pacers feature the company’s Reactive ATP algorithm intended to slow the progression of atrial fibrillation and BlueSynch technology which allows for a...
Source: Mass Device - November 20, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Assist Devices Cardiac Implants Cardiovascular Food & Drug Administration (FDA) Regulatory/Compliance Medtronic Source Type: news

EBR Systems pulls in $50m for wireless pacer
EBR Systems said yesterday that it raised $50 million to back a clinical trial for the wireless cardiac pacemaker it’s developing after winning CE Mark approval for a second-generation wireless transmitter. EBR’s device, which it calls wireless stimulation endocardially or Wise, uses a subcutaneous generator to wirelessly deliver ultrasound energy to a “pellet” implanted in the right ventricle, which it uses to synchronize the left and right ventricles. The system is designed to eliminate the need for a left ventricular lead by allowing the operating physician to place the stimulation “pellet” in a pat...
Source: Mass Device - November 15, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Clinical Trials Funding Roundup Regulatory/Compliance Wall Street Beat Cardiac Rhythm Management EBR Systems Inc. Source Type: news

MassDevice.com +5 | The top 5 medtech stories for October 13, 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. 10 tips for selecting and managing a medtech development partner There many things to consider when searching for and interacting with a product development firm – and the stakes are high! Most early-stage medical device comp...
Source: Mass Device - October 13, 2017 Category: Medical Devices Authors: MassDevice Tags: News Well Plus 5 Source Type: news

Medtronic, Mercy hospitals ink data-sharing deal
Medtronic (NYSE:MDT) and the Mercy healthcare system today said they inked a data sharing and analysis deal to gather clinical evidence for “medical device innovation and patient access.” The program aims to gather efficacy and safety data generated during routine care, rather than via expensive and time-consuming clinical trials. The first phase is designed to collect anonymized data from some 80,000 heart failure patients treated with cardiac resynchronization therapy. “Having the ability to study patient care pathways and conditions before and after exposure to a medical device is crucial to understand...
Source: Mass Device - October 13, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Big Data Hospital Care Wall Street Beat Medtronic Source Type: news

MassDevice.com +5 | The top 5 medtech stories for September 25, 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. EY is upbeat about the medical device industry: Here’s why The medical device industry is growing, at a healthy and steady pace. This is according to EY’s Pulse of the Industry report, which was released today at AdvaMed’...
Source: Mass Device - September 25, 2017 Category: Medical Devices Authors: MassDevice Tags: News Well Plus 5 Source Type: news

Boston Scientific launches MRI-safe Resonate devices with HeartLogic diagnostic in U.S.
Boston Scientific (NYSE:BSX) launched today its Resonate implantable cardioverter defibrillator and cardiac resynchronization therapy defibrillator systems with the HeartLogic heart failure diagnostic tool. The devices are approved by the FDA for conditional use in an MRI environment, the company reported. Boston Scientific’s HeartLogic diagnostic warns doctors of worsening heart failure, collecting data from sensors monitoring heart sounds, thoracic impedance, heart rate and activity and respiration rate and volume. The company touted its alert system as the first and only of its kind in an implantable device with ...
Source: Mass Device - September 25, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Cardiovascular Diagnostics Food & Drug Administration (FDA) Regulatory/Compliance Wall Street Beat Boston Scientific Source Type: news

Boston Scientific Announces U.S. FDA Approval for MRI Labeling on High-Voltage Devices and U.S. Launch of Resonate(TM) Devices with the HeartLogic(TM) Heart Failure Diagnostic
MARLBOROUGH, Mass., Sept. 25, 2017 -- (Healthcare Sales & Marketing Network) -- Boston Scientific (NYSE: BSX) has launched the Resonate family of implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) sys... Devices, Cardiology, FDA Boston Scientific, Resonate, ICD , CRT-D, SmartCRT, HeartLogic (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - September 25, 2017 Category: Pharmaceuticals Source Type: news

Boston Scientific & #039;s New Defibrillators Really Are Smarter
A suite of sensors designed to make implantable defibrillators smarter received a boost of support this week in the form of a late-breaking clinical trial presentation at the Heart Failure Society of America's annual scientific meeting in Dallas. New data confirmed that Boston Scientific's HeartLogic Diagnostic, which is slated for commercial release later this year as part of a new line of implantable heart devices, accurately enhanced the ability to classify patients at high or low risk of a future heart failure event. The Multisensor Chronic Evaluation in Ambulatory Heart Failure Patients (MultiSENSE) trial showed tha...
Source: MDDI - September 20, 2017 Category: Medical Devices Authors: MDDI Staff Tags: Cardiovascular Software Source Type: news

MassDevice.com +5 | The top 5 medtech stories for September 6, 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. Did Congress just kill medical device innovation? The Medical Device User Fee Amendments bill that Congress passed this year is more than an FDA fees hike for device companies; it could inhibit innovation, says Michael Drues, a...
Source: Mass Device - September 6, 2017 Category: Medical Devices Authors: MassDevice Tags: News Well Plus 5 Source Type: news

Boston Scientific wins FCA whistleblower suit over Cognis CRT-Ds, Teligen ICDs
Boston Scientific (NYSE:BSX) has prevailed in dismissing a whistleblower suit alleging its sales of the Cognis cardiac resynchronization therapy defibrillators and Teligen implantable cardioverter defibrillators between 2008 and 2009 violated various false claims acts, according to court documents released late last week. In the suit, Boston Scientific was accused of defrauding the FDA by not reporting alleged defects in the devices which caused insecure connections between the leads and headers they attached to. The complaint alleged that Boston Scientific was made aware of the issue after launching the devices in Europe...
Source: Mass Device - September 6, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Assist Devices Legal News Boston Scientific Source Type: news

ESC 2017 Roundup: Biotronik touts lowered mortality for AF patients treated with cath ablation
Biotronik today released results from the Castle-AF study exploring the use of catheter ablation to treat heart failure patients with atrial fibrillation, touting a 38% composite reduction in all-cause mortality and hospitalization for worsening heart failure. The 398-patient, 33-site study compared the results of catheter ablation treatment for AF in heart failure patients using implantable cardioverter defibrillators or cardiac resynchronization therapy defibrillators to standard-of-care pharmacological therapy, the company said. Biotronik touted it as the largest study of its kind to date. Results indicated a 47% reduc...
Source: Mass Device - August 28, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Assist Devices Cardiac Implants Cardiovascular Clinical Trials Biotronik Medtronic Source Type: news

Medtronic wins CE Mark for MRI-safe Attain Stability quad CRT leads
Medtronic (NYSE:MDT) said today it won CE Mark approval in the European Union for its Attain Stability quad magnetic resonance imaging-safe left heart leads designed for cardiac resynchronization therapy defibrillators and pacemakers. The leads feature MRI SureScan technology and are cleared for use with 3 Tesla and 1.5T MRI scans, the Fridley, Minn.-based company said. The leads also feature a side-helix designed to be fixated in veins of various sizes, the company said. Medtronic said it has initiated a limited European launch, with the 1st commercial implants recently performed at Bergen, Norway’s Haukeland Unive...
Source: Mass Device - August 21, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Regulatory/Compliance Medtronic Source Type: news

Biotronik launches Edora HF-T MRI-safe CRT-P, touts as smallest in US
Biotronik said today it launched its Edora HF-T magnetic resonance-conditional quadripolar cardiac resynchronization therapy pacemaker, touting it as the smallest device of its type available in the US. The German medical device company said the Edora HF-T QP has a volume of 15 cc, making it the smallest MR conditional CRT-P available in the US. The device has a lifespan of 10 years and features MRI Autodetect, Closed Loop Stimulation and Biotronik Home Monitoring technology, the company said. “Patient care is a constant journey. It doesn’t end when the patient leaves my office or recovers from a procedure. As...
Source: Mass Device - August 21, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Cardiac Assist Devices Cardiac Implants Cardiovascular Biotronik Source Type: news

BIOTRONIK US Launches Smallest MR Conditional Quadripolar Cardiac Resynchronization Therapy Pacemaker
Edora HF-T QP Completes BIOTRONIK's ProMRI Portfolio LAKE OSWEGO, Ore., Aug. 21, 2017 -- (Healthcare Sales & Marketing Network) -- BIOTRONIK today announced FDA approval and commercial availability of Edora HF-T QP, an MR conditional quadripolar (QP) c... Devices, Cardiology, FDA, Product Launch BIOTRONIK, Edora HF-T QP, cardiac resynchronization therapy, pacemaker (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - August 21, 2017 Category: Pharmaceuticals Source Type: news

Medtronic wins Health Canada approval for MRI-safe line of CRT-Ds
Medtronic (NYSE:MDT) said today its Medtronic Canada subsidiary received Health Canada approval for its line of MRI-conditional cardiac resynchronization therapy defibrillators, touting them as the 1st MRI CRT-Ds cleared in the region. With the new clearance, Fridley, Minn.-based Medtronic’s Amplia MRI Quad CRT-D SureScan and Compia MRI Quad CRT-D SureScan systems, which are currently available in the region, are cleared for MRI scans of any part of the body without positioning restrictions. Both newly cleared devices can be paired with the company’s Attain Performa MRI SureScan quadripolar leads, Medtronic s...
Source: Mass Device - July 26, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Assist Devices Cardiac Implants Cardiovascular Regulatory/Compliance Medtronic Source Type: news