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 […]
Cardiac Implants
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 company said the Ilivia device features both its ProMRI technology and its MRI AutoDetect feature which automatically recognizes when the user is in an MRI environment and switches to MRI mode. The device then switches back to normal functionality […]
Pivotal trial pits St. Jude Medical’s Amplatzer Amulet anti-stroke device against Boston Scientific’s Watchman
St. Jude Medical (NYSE:STJ) said today that it launched a U.S. pivotal trial for its Amplatzer Amulet cardiac implant, which is designed to reduce the risk of stroke in patients with atrial fibrillation. The Amplatzer Amulet device is designed to occlude the left atrial appendage to prevent the formation of blood clots that could lead to […]
Study: TAVR safer than surgery in low-risk heart failure patients
Transcatheter aortic valve replacement procedures with self-expanding systems resulted in higher survival rates for patients at lower risk for surgery when compared to surgical aortic valve replacement procedures, according to a study released this month. Results from the study, which compared Medtronic‘s (NYSE:MDT) self-expanding CoreValve TAVR system, were published in JAMA Cardiology this month. The retrospective […]
SynCardia denies competitor’s market exit claim
SynCardia Systems isn’t exiting the market quite yet, according to a press release posted today in response to a competitor’s claim. Syncardia makes an artificial heart system designed to replace the functions of both the left and right ventricles and all 4 heart valves. “SynCardia’s machine works quite well. But it’s a very old machine […]
ReliantHeart wins CE Mark for aVAD left ventricular assist device
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 […]
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 […]