The Watchman heart implant made by Boston Scientific (NYSE:BSX) improved quality-of-life measures more than warfarin in atrial fibrillation patients after 1 year, according to a study in the Journal of the American College of Cardiology.
Structural Heart
TAVI: Medtronic lands European win for next-gen Engager heart valve
Medical device giant Medtronic (NYSE:MDT) won European regulatory approval for its Engager transcatheter aortic valve implantation system, the company announced today.
The CE Mark indication includes approval for transapical delivery of the valve in treatment of patients with aortic stenosis who are too sick to undergo traditional surgery.
CardioKinetix closes $23M tranche in $48M Series E round
CardioKinetix said it’s raised $48 million in its Series E round with the closure of a 2nd tranche worth $23 million and plans to use the proceeds to further its Parachute ventricular partitioning device, which is in a pivotal trial.
Medtronic wins FDA nod for pulmonary valve trial
Medtronic (NYSE:MDT) said the FDA approved an early trial of its native outflow tract transcatheter pulmonary valve under a new agency program for early feasibility studies.
The TPV device is designed for patients born without a right ventricle-to-pulmonary artery conduit, which provides blood to the lungs, as an alternative to open heart surgery.
Medtronic wins expanded FDA approval for diabetic-friendly Resolute Integrity stent
Biotronik lands Euro approval for MRI-friendly heart implants
German medical device maker Biotronik won European regulatory approval for its Ilesto 7 line of MRI-friendly heart implants.
The Ilesto 7 line includes cardiac resynchronization therapy defibrillator and one of the world’s smallest implantable cardioverter-defibrillators, according to Biotronik.
Legal: OrbusNeich takes Boston Scientific patent row to Germany, the Netherlands
OrbusNeich is taking a recent patent infringement win against Boston Scientific (NYSE:BSX) even further, filing lawsuits in both Germany and the Netherlands to allege patent infringement over stent technology.
Covidien closes enrollment in iliac stent studies
Abbott’s MitraClip gets a date with the FDA
Boston Scientific launches Promus Premier stent in Europe
Boston Scientific (NYSE:BSX) said it plans to immediately launch its Promus Premier drug-eluting stent across the pond, now that the European Union has given the device CE Mark approval.
Direct Flow aims to use heart valve giants’ experience against them
Being one of the smallest players on the field means you’ve got to differentiate yourself to stand out against the titans of the game, and that’s what Direct Flow Medical CEO Bernie Lyons aims to do.