FDA grants breakthrough device designation for novel pulmonary hypertension system

The FDA has granted breakthrough device designation for the Aria CV Pulmonary Hypertension System, according to a manufacturer press release.

“Despite the availability of multiple drug therapies, pulmonary hypertension remains a disease with large unmet needs,” Gregg W. Stone, MD, a member of Aria’s Scientific Advisory board and director of academic affairs for Mount Sinai Heart Health System, said in the release. “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.”

Aria’s CV PH System is an implantable device that is designed to restore healthy, elastic pulmonary arteries to reduce cardiac workload and enhance blood flow. These benefits of the system have a potential to improve the duration and quality of life for patients.

“The FDA’s designation of the Aria CV PH System as a breakthrough device affords multiple potential benefits to the company including flexible clinical trial design and facilitated patient access through CMS’s revised reimbursement pathway,” Dan Gladney, CEO and president of Aria CV. “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.”

The device won the Shark Tank Innovation Competition at the Transcatheter Cardiovascular Therapeutics Conference in 2018. – by Erin T. Welsh