Corvia Medical wins FDA nod for trial, inks exclusive buyout deal with strategic backer

Corvia Medical said today that it won an investigational device exemption from the FDA for a clinical trial of its cardiac implant designed to treat diastolic heart failure and inked a deal with an unnamed strategic investor that includes an exclusive buyout option. Corvia’s transcatheter InterAtrial shunt device is designed to lower blood pressure in the left atrium and lungs by creating a small opening between the left and right atria, according to Corvia’s website. Tewksbury, Mass.-based Corvia said the 100-patient Reduce Lap-HF I study is a prospective, multicenter, randomized controlled trial. The primary safety endpoint is major adverse cardiac & cerebrovascular event at 6 months, defined as death, stroke, myocardial infarction or systemic embolic event excluding pulmonary thromboembolism. “The IDE approval and strategic funding solidify our commitment to advancing our breakthrough therapy for patients suffering from chronic heart failure,” president & CEO George Fazio said in prepared remarks. “We look forward to providing physicians a technology that is designed to facilitate continuous and dynamic decompression of the left atrium and address the debilitating symptoms of heart failure.” “We are especially pleased to have the support of a strategic partner with best-in-class global resources as we move this novel treatment toward international commercialization,” Fazio added. Corvia is also running a 100-pati...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Cardiac Implants Cardiovascular Clinical Trials Mergers & Acquisitions Corvia Medical Source Type: news