Aria CV announced that it won FDA breakthrough device designation for its pulmonary hypertension (PH) system for treating pulmonary arterial hypertension (PAH) that can lead to heart failure.
The implanted system is designed to restore the benefits of a healthy, elastic pulmonary artery, according to a news release. The restoration should lead to reduced cardiac workload and enhance blood flow, potentially improving both the duration and quality of life.
The PH system has the potential to treat PAH effectively with fewer side effects when compared to the available drug therapies, said Dr. Gregg Stone, director of academic affairs for Mount Sinai Heart Health System and a member of Aria CV’s scientific advisory board.
The breakthrough device designation from FDA will allow for more flexible clinical trial design and facilitated patient access through CMS’s revised reimbursement pathway, Aria CV president & CEO Dan Gladney said in the release. “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.”