February 6, 2020
Aria CV’s Pulmonary Hypertension System Granted FDA Breakthrough Device Designation
February 6, 2020—Aria CV, Inc. announced its Aria CV pulmonary hypertension system has received Breakthrough Device Designation from the FDA. The Aria CV pulmonary hypertension system is an implant designed to restore the benefits of a healthy, elastic pulmonary artery, which reduces cardiac workflow and enhances blood flow, according to the company.
“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,” commented Gregg W. Stone, MD, in the company’s announcement. Dr. Stone is Director of Academic Affairs for Mount Sinai Heart Health System, in New York, New York, and is a member of Aria’s Scientific Advisory Board.
The company highlighted the benefits the Breakthrough Device Designation offers including a more flexible clinical trial design and facilitated patient access through Centers for Medicare & Medicaid’s revised reimbursement pathway.
Aria CV is a developer of medical devices for the treatment of pulmonary artery hypertension based in Saint Paul, Minnesota. The company completed a successful first-in-human clinical study in Vienna, Austria and is preparing for a United States clinical trial under FDA’s Early Feasibility Study program to evaluate long-term implants in patients with pulmonary artery hypertension.