The 2024 edition of the Transcatheter Cardiovascular Therapeutics (TCT) conference once again highlighted significant innovations in cardiovascular care. This year’s event in Washington, D.C., featured company updates on all types of technologies, including heart valves, access and closure devices, drug-eluting implants, intravascular lithotripsy (IVL), renal denervation (RDN) and more. Some of the biggest names in […]
Boston Scientific
Boston Scientific Acurate neo2 TAVR misses primary endpoint in IDE trial
Boston Scientific (NYSE:BSX) today announced that a study of its Acurate neo2 aortic valve system missed its primary endpoint. The ACURATE IDE study evaluated Acurate neo2, a transcatheter aortic valve replacement (TAVR) system, in the treatment of patients with severe, symptomatic aortic stenosis at low, intermediate, high and extreme risk of open-heart surgery. Investigators presented […]
NICE recommends Boston Scientific HeartLogic tech for managing people with cardiac implants
New UK National Institute for Health and Care Excellence (NICE) guidance supports the use of the Boston Scientific (NYSE:BSX) HeartLogic platform. NICE provides evidence-based recommendations to improve health and social care in the National Health Service in England and Wales. Its new guidance recommends the use of the HeartLogic heart failure diagnostic as an option […]
Boston Scientific still expects Axonics deal to close this year, posts Street-beating Q3
Boston Scientific today reported third-quarter results that came in ahead of the consensus forecast, raising its 2024 guidance again. The company’s CEO also said on its third-quarter earnings call that Boston Scientific expects to close its acquisition of Axonics in the fourth quarter of this year. “We’re excited to add this excellent business into Boston […]
Boston Scientific wins FDA nods for nav-enabled Farapulse catheter, software
Boston Scientific announced today that it received FDA approval for its navigation-enabled Farawave Nav ablation catheter and clearance for new Faraview software. The two technologies comprise part of the company’s Farapulse pulsed field ablation (PFA) system. Boston Scientific initially won FDA approval for Farapulse in January. In doing so, it became second company to earn […]
Boston Scientific warns on some PolarX cryoablation catheters following reports of death
Boston Scientific issued an urgent field safety notice in Europe to notify customers of updates to its PolarX cryoablation catheters. Marlborough, Massachusetts-based Boston Scientific’s notice relates to the PolarX and PolarX FIT cryoablation catheters. These systems work as part of the PolarX cryoablation system, used with the SmartFreeze console. The company updated the instructions for […]
Boston Scientific wins Farapulse PFA approval in Japan
Boston Scientific continues to expand the reach of its Farapulse pulsed field ablation system for treating atrial fibrillation. The Marlborough, Massachusett–based company announced today that Japan’s Pharmaceuticals and Medical Device Agency has approved Farapulse, which is indicated for the isolation of pulmonary veins in the treatment of paroxysmal atrial fibrillation. Medtronic announced Japanese approval of […]
The top 10 urology device stories of 2024 so far
Urology Week 2024, which closes out The Urology Foundation’s Urology Awareness Month, is a good time to highlight the innovations in this space. This week (Sept. 23-29), is an initiative of the European Association of Urology that brings together national urological societies, urology practitioners, urology nurses, patients and their families, and politicians to create awareness of urological […]
Boston Scientific closes Silk Road Medical acquisition
Boston Scientific announced today that it completed its $1.18 billion acquisition of Silk Road Medical . The acquisition includes a purchase price of $27.50 per share for a full enterprise value of approximately $1.18 billion. Boston Scientific expects an immaterial impact from the acquisition on its adjusted EPS in 2024 and 2025. It expects an accretive […]
FDA approves expanded label for Boston Scientific Ingevity+ pacing leads
Boston Scientific announced today that it received FDA approval to expand the indication for its current-generation Ingevity+ pacing leads. The expanded indication includes conduction system pacing (CSP) and sensing of the left bundle branch area (LBBA) when the pacing leads — thin wires placed inside the heart and connected to an implantable device — are […]
Boston Scientific expected to close Silk Road Medical acquisition soon after antitrust waiting period expires
Silk Road Medical today filed with the SEC to confirm the expiration of an antitrust waiting period for its merger with Boston Scientific . In June, Boston Scientific announced that it agreed to acquire Silk Road Medical in a deal worth approximately $1.16 billion. Sunnyvale, California-based Silk Road Medical develops products designed to prevent stroke […]