The implantable Aria CV Pulmonary Hypertension System has received a breakthrough device designation from the FDA, according to the manufacturer Aria CV. The device is a pulmonary artery balloon system that inflates and deflates with the patient’s heartbeat.
The system is designed to restore the benefits of a healthy, elastic pulmonary artery, which in turn reduces cardiac workload and enhances blood flow, according to the company. The benefits could improve both duration and quality of life.
“Despite the availability of multiple drug therapies, pulmonary hypertension remains a disease with large, unmet needs. 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,” said Gregg W. Stone MD, Director of Academic Affairs for Mount Sinai Heart Health System and a member of Aria’s Scientific Advisory Board.
The Breakthrough Devices Program (BDP) is intended to expedite the FDA review and approval of designated devices that may provide more effective treatment of life-threatening or irreversibly debilitating diseases.
“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. 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,” said Dan Gladney, CEO and President of Aria CV.