The Watchman left atrial appendage device, distributed by Marlborough, Mass.-based Boston Scientific Corp., holds a unique place in the annals of med tech regulation, but 50-month data from two registries show a lower rate of hemorrhagic stroke than previously reported for the device.
Heart failure with preserved ejection fraction (HFpEF), also known as diastolic heart failure, accounts for roughly half of all heart failure cases worldwide. The condition, which occurs when the ventricles do not relax as they fill with blood following heart muscle contractions, is especially common in elderly women, striking up to 10% of those over 80 years old. Now stem cell biotech firm Novoheart Holdings Inc., of Vancouver, British Columbia, is partnering with Astrazeneca plc, of Cambridge, U.K., to co-develop a human-specific in vitro, functional model of HFpEF. The goal is to give drug researchers critical clues of a drug candidate’s efficacy before it is tested in patients.
TORONTO – If you’ve successfully expanded your medical technologies business once, why not do it a second time? The answer was quick in coming Nov. 5, when Quebec City-based Opsens Inc. announced its next goal: To accelerate development of products beyond its current line of technologies for measuring coronary pressure into the structural cardiology space.
The U.S. FDA has given Medtronic plc a green light for its In.Pact AV drug-coated balloon, the second application for the Dublin-based company’s In.Pact DCB platform. The paclitaxel-coated balloon is now indicated for the treatment failing arteriovenous (AV) access in patients undergoing dialysis due to end-stage renal disease (ESRD). In.Pact AV leverages technology from Medtronic’s In.Pact Admiral DCB, which first snagged FDA approval in 2015 for treatment of superficial femoral artery (SFA) lesions above the knee.
London-based Livanova plc is exiting its Caisson transcatheter mitral valve replacement (TMVR) program as it looks to restructure its heart valve business. According to the company, the heart valve business line represented nearly $130 million in revenue for full-year 2018 and experienced a revenue decline over the last five years. It attributed the declines to multiple market conditions.
The U.S. FDA has granted breakthrough device designation for Bioventrix Inc.’s Revivent Tc Transcatheter Ventricular Enhancement System for heart failure following a heart attack. The system is designed to exclude scar tissue that has formed on the left ventricle in a procedure that is less invasive than current medical options and better than drug therapy, allowing healthy heart tissue to function more efficiently. The left ventricle is the heart’s pumping chamber, and scarring can prevent it from contracting and providing the steady circulation of blood that the body needs.