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-patient, single-arm safety & efficacy study of the IASD System II, according to ClinicalTrials.gov. The trial, Reduce LAP-AF, is slated to be fully complete in May 2019.
“Treating heart failure patients, especially those with preserved ejection fraction, continues to be a challenge as current pharmacological treatments are ineffective,” said Corvia’s scientific advisory group chairman, Dr. Martin Leon of New York City’s Columbia University Medical Center. “We expect the results of the Reduce Lap-HF I randomized study to confirm the significant clinical benefits demonstrated in the observational studies and will show clinically meaningful improvements in [New York Heart Assn.] functional class, exercise capacity, and quality of life for this patient population.”
Last September Corvia drummed up a $34 million equity round from 9 unnamed investors. The company, formerly known as DC Devices, closed a $10.7 million funding round in March 2013 and added another $34 million in a Series D round in July 2014.