Aria CV’s PH System Designated as Breakthrough Device by FDA

Aria CV‘s medical device for treating pulmonary hypertension (PH) has been given a Breakthrough Device designation by the United States Food and Drug Administration (FDA).

The Aria CV PH System is designed to reduce the symptoms associated with PH — a condition that develops due to high blood pressure in the pulmonary arteries (blood vessels of the lungs), and that potentially leads to an increased workload for the heart muscles and to right heart failure.

The device won the TCT 2018 Shark Tank Competition, a contest that highlights the most innovative devices and technologies in the field of cardiovascular medicine.

Designed to improve the quality of life of PH patients and increase their survival rate, the device helps restore damaged arteries in the lungs, thus decreasing the cardiac workload and blood pressure, and improving blood flow. It consists of a balloon that is implanted in the pulmonary artery, which then inflates and deflates in sync with the heart cycle.

The new designation, which is part of the FDA’s Breakthrough Devices Program, helps accelerate the agency’s review of devices that hold the potential to more effectively treat a fatal or irreversible disease, potentially leading to faster approval.

“Despite the availability of multiple drug therapies, pulmonary hypertension remains a disease with large, unmet needs,” Gregg W. Stone, MD, a director at Mount Sinai Heart Health System and member of Aria’s scientific advisory board, said in a press 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.”

Dan Gladney, CEO and president of Aria CV, added: “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 [U.S. Centers for Medicare & Medicaid Services]’s revised reimbursement pathway.”

The company’s 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,” he said.