Aria CV Receives FDA Breakthrough Designation for Its Medical Device for Treating Pulmonary Arterial HypertensionFeb 6, 2020
February 06, 2020 07:00 AM Eastern Standard Time
SAINT PAUL, Minn.–(BUSINESS WIRE)–Aria CV, Inc., a developer of medical devices treating Pulmonary Arterial
Hypertension (PAH), today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough
Device Designation for the Aria CV Pulmonary Hypertension System (Aria CV PH System).
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.