The U.S. FDA on Feb. 6 granted Breakthrough Device Designation to medical device developer Aria CV, Inc., for its Aria CV Pulmonary Hypertension System.
The Aria CV PH System works to reduce cardiac workload and enhance patients’ blood flow by restoring the benefits of a “healthy, elastic pulmonary artery,” according to a company statement. When untreated, pulmonary hypertension—which is already a highly progressive disease—can lead to even bigger problems, like heart failure.
“Despite the availability of multiple drug therapies, pulmonary hypertension remains a disease with large, unmet needs,” Gregg W. Stone, the director of academic affairs for Mount Sinai Heart Health System and a member of Aria CV’s scientific advisory board, said in the statement. “Aria’s device-based solution has the potential to treat this disease more effectively and with fewer side effects, and the breakthrough designation provides the opportunity for earlier access to patients.”
Breakthrough designation allows for Aria CV’s PH System to be fast-tracked through the regulatory approval process, therefore expediting patient access.
“Our mission is to address the unmet clinical need for this life-threatening disease with an effective treatment option, and this designation brings us one step closer to delivering on this mission,” Dan Gladney, CEO and president of Aria CV, said.