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. BDP is intended to help patients gain faster access by expediting designated device development, assessment, and review, while preserving the statutory standards for premarket approval, consistent with the FDA’s mission to protect and promote public health.
“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.
PAH is a progressive, highly debilitating disease that may lead to heart failure. The implanted Aria CV PH System is designed to restore the benefits of a healthy, elastic pulmonary artery, which in turn reduces cardiac workload and enhances blood flow. These benefits have the potential to improve both duration and quality of life.
“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.