Arterial Shunt for PAH Receives FDA’s Breakthrough Device Designation

V-Wave’s new interatrial shunt — a medical device designed to reduce arterial heart pressure — has been granted breakthrough device designation by the U.S. Food and Drug Administration (FDA) for the treatment of people with pulmonary arterial hypertension (PAH).

This is the second breakthrough device designation for the V-Wave Interatrial Shunt System in as many months. The shunt was granted breakthrough status in August for the treatment of heart failure. 

Breakthrough status is given to medical equipment that provides significant advantages over currently available options for treating irreversibly debilitating or life-threatening conditions. It is designed to support and accelerate the device’s development and approval.

PAH is characterized by high blood pressure in the pulmonary artery — which drives blood directly from the heart to the lungs — and can potentially result in heart failure. 

To date, no effective PAH treatment is available. Instead, patients must take multiple medications that only temporarily improve their symptoms. An alternative option is to undergo balloon atrial septostomy, a technique that creates a hole, or shunt, between the left and right atriums of the heart that will allow blood to flow between them, reducing blood pressure.

This invasive procedure has been demonstrated to improve right ventricular function, PAH symptoms, and exercise capacity. However, its use is limited because the shunt frequently closes, and there is inadequate control over the shunt size. 

V-Wave is developing a new, minimally invasive device that can be implanted in the heart by a catheter inserted through a vein in the groin. The procedure is similar to the right heart catheterization commonly used for PAH diagnosis.

“The goal of the implant is to create a well-controlled, durable shunt that will yield more reliable results and prolong the benefits found with septostomy,” William T. Abraham, MD, V-Wave’s chief medical officer, said in a press release.

“The FDA has agreed to initial human testing of the V-Wave shunt in patients who remain severely symptomatic despite multiple medications,” he said.

A multinational, open-label study (NCT03838445) is planned, which will enroll approximately 20 people with PAH — those with WHO class III or IV, or history of fainting — who have been receiving maximum tolerable dose of available medications for at least four months. The trial is named RELIEVE-PAH, an acronynm for REducing Right ventricuLar faIlure with thE V-waVe Shunt in Pulmonary Arterial Hypertension.

Researchers will assess the device’s safety, performance, and signs of clinical effectiveness during the first year after implantation and up to maximum of five years. 

“Given the small patient population and the severity of the disease, Breakthrough Designation may provide an opportunity for expedited access of this novel therapeutic approach to highly symptomatic and compromised PAH patients who need better treatment options as quickly as possible,” Abraham said.