V-Wave's Interarterial Shunt for Pulmonary Arterial Hypertension Granted FDA Breakthrough Device Designation

September 12, 2019—V-Wave Ltd. announced that the FDA has granted Breakthrough Device designation for the company's interatrial shunt for pulmonary arterial hypertension (PAH). The company's minimally invasive, implanted interatrial shunt device is being evaluated for PAH in the global RELIEVE-PAH early feasibility study conducted under an investigational device exemption.

In August, the company announced that a Breakthrough Device designation was granted for the interatrial shunt for heart failure.

According to the company, the implant is intended to create a well-controlled, durable shunt that will yield more reliable results and prolong the benefits found with septostomy. The FDA has agreed to initial human testing of the V-Wave shunt in patients who remain severely symptomatic despite multiple medications.

V-Wave is a privately held medical device company with offices in Israel and the United States. The V-Wave interatrial shunt system is under clinical investigation and is not available for sale in the United States or other countries, advised the company.