The FDA has granted Breakthrough Device Designation for the Aria CV pulmonary hypertension system (Aria CV PH System). A press release reports that Aria has already performed a successful acute first- in-human clinical study in Vienna, Austria, and is now preparing for a US clinical trial under the FDA’s early feasibility study programme to evaluate long-term implants of its device in patients with pulmonary arterial hypertension. It adds that Aria CV’s major shareholders include Catalyst Health Ventures, Broadview Ventures, Biostar Ventures and a strategic investor.
The company, according to a press release, is based in St Paul (USA) and was founded in 2010 by doctors John Scandurra and Karl Vollmers, following development work they had done at the University of Minnesota’s Earl E. Bakken Medical Devices Center.
Gregg W Stone (Mount Sinai Heart Health System, New York, USA), a member of Aria’s Scientific Advisory Board, comments: “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.”
The Breakthrough Devices programme 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. It 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.