ReliantHeart said yesterday it won CE Mark approval in the European Union for its aVAD left ventricular assist device. The aVAD device is an axial flow LVAD that features remote monitoring and flow measurement, according to an MD+DI report. ReliantHeart said that manufacturing of the device is already underway, with 65 units slated to be […]
Cardiac Implants
Boston Scientific issues urgent field safety notice for select Lotus valves
Boston Scientific (NYSE:BSX) this week issued a voluntary field safety corrective action for its Lotus Valve Systems, looking to recall units from the field over issues with release mandrel breakage. The company is looking to “remove units from the field” that were manufactured prior to a component related change made in March this year, and specified […]
Medtronic wins expanded CE Mark for Evolut R TAVR system
Medtronic (NYSE:MDT) said today it won expanded CE Mark approval in the European Union for its CoreValve Evolut R transcatheter aortic valve replacement, now approved for aortic stenosis patients at intermediate risk for open-heart surgery. The Fridley, Minn.-based company touted the win, saying it is the 1st TAVI system to have received expanded indication in Europe […]
Study: St. Jude Medical’s CardioMEMS lowers all-cause admissions in HF patients
Use of St. Jude Medical‘s (NYSE:STJ) CardioMEMS implantable heart monitor in patients previously hospitalized for heart failure can significantly reduces all-cause heart failure admissions, according to data from a new study released late last month. Data from an oral abstract of the study was presented at the 12th Annual AAHFN meeting, according to a report […]
Abbott wins FDA nod for Absorb stent
Abbott (NYSE:ABT) said today it won FDA premarket approval for its Absorb bioresorbable everolimus eluting heart stent, touting it as the 1st fully dissolving stent approved for treating coronary artery disease. The newly cleared stent is designed to dissolve completely after approximately 3 years after serving to keep clogged arteries open and promote healing in […]
AtriCure wins CE Mark for AtriClip Pro2 LAA occluder
AtriCure (NSDQ:ATRC) said today it won CE Mark approval in the European Union for the AtriClip Pro2 left atrial appendage exclusion system designed for minimally-invasive LAA occlusion procedures. The AtriClip Pro2 system is designed with an ambidextrous locking and trigger-style clip closing mechanism, the West Chester, Ohio-based company said, as well as handle-based active articulation levers […]
Medtronic launches Beacon HF monitoring service
Medtronic (NYSE:MDT) said today it launched its Beacon heart failure management service in the U.S., designed to monitor data from cardiac pacing devices to improve early interventions before heart failure events. The service, which integrates data from the company’s implantable cardioverter defibrillator and cardiac resynchronization therapy devices, will allow patients to engage in daily health checks to […]
St. Jude wins CE Mark, launches SyncAV CRT algorithm
St. Jude Medical (NYSE:STJ) said today it won CE Mark approval in the European Union and launched its SyncAV CR software algorithm designed to optimize the company’s MultiPoint pacing technology. The newly released software algorithm is designed to address and treat heart failure patients who are not responsive to other pacing options, and can automatically adjust […]
CorMatrix launches Tyke cardiac tissue repair device for neonates
CorMatrix Cardiovascular said today it launched its CorMatrix Tyke cardiac tissue repair patch designed for correcting congenital heart defects in neonates and infants, touting the 1st successful procedures utilizing the patch. The CorMatrix Tyke is a patch designed to repair pericardial structures and as an epicardial covering or for intracardiac defects, septal defects, annulus repair, suture-line […]
Biotronik launches its smallest MR-conditional pacing leads in US
Biotronik said today it launched its Solia S ProMRI 5.6 Fr magnetic resonance imaging conditional pacing leads in the U.S., touting them as the smallest available on the market. The newly launched leads, available in 45, 53 and 60 centimeter lengths, were approved last week based on data collected from the pre-market study phase of […]
Chinese dev LifeTech wins CE Mark for LAA closure device
Chinese developer LifeTech Scientific said today it won CE Mark approval in the European Union for its LAmbre left atrial appendage closure system, touting it as the 1st Chinese-developed LAA closure system to receive such approval. The LAmbre system is designed for the closure of the LAA percutaneously through a small 8 to 10 Fr […]