On the heels of a reimbursement setback in the U.S., Boston Scientific announced that it has received a CE mark for the second-generation Watchman FLX implant to prevent stroke by plugging the heart's left atrial appendage.
The FDA just publicized the voluntary Class 1 recall of Boston Scientific's RotaWire Elite and wireClip Torquer Guidewire and Guidewire Manipulation Device because of complaints of wire fracture.
Boston Scientific's stroke-preventing Watchman was just hit by bad news on multiple fronts. The FDA revealed that the Watchman is the subject of two Class 2 recalls, while the Centers for Medicare & Medicaid Services has just deemed reimbursement of the device "not reasonable and necessary."
Cardiovascular-focused Boston Scientific is moving deeper into oncology and expanding its vascular offerings with the purchase of the interventional radiology portfolio of CeloNova BioSciences. The deal with the San Antonio, TX-based startup involves a $70 million upfront payment with additional, undisclosed regulatory and sales milestones.
Boston Scientific is alleging that Edwards' Sapien 3 TAVR infringes its patents related to adaptive sealing technology in an intellectual-property lawsuit filed against the competitor in Germany.
Boston Scientific said during its Q3 earnings call that it is going to charge a premium for its Synergy drug-eluting stent in the U.S., as it seeks to capitalize on becoming the first company to earn FDA approval for a (partially) bioresorable stent.
The ongoing Transcatheter Cardiovascular Therapeutics conference in San Francisco couldn't be any more timely, with bigwigs Abbott, Edwards, and Medtronic dropping more than $1 billion on the burgeoning transcatheter mitral valve repair/replacement market in recent months.
Boston Scientific announced that it has obtained an exclusive $200 million option to acquire Israel's MValve Technologies, maker of a transcatheter mitral valve replacement system for mitral regurgitation. Boston Scientific also said it is providing additional financing to the company in anticipation of a first in-human clinical trial.
Remote patient monitoring isn't a core business for Boston Scientific, but it is looking to gain access to the most cutting-edge tech in the field. It's launched the Boston Scientific Connected Patient Challenge: an open innovation challenge to solicit ideas and collaborations for remote patient monitoring.
The typical approach to achieving consistent and high-quality vascular access for chronic kidney disease patients in need of dialysis is to surgically construct an arteriovenous (AV) fistula, creating a direct connection between an artery and a vein in the arm. Startup TVA Medical has a minimally invasive, catheter-based that can achieve the same goal--only without surgery.