Based in Minnesota, US, Aria CV is developing a medical device designed to improve the lives of patients living with the disease of Pulmonary Arterial Hypertension (PAH)
The US FDA’s Center for Devices and Radiological Health (Credit: The U.S. Food and Drug Administration)
Aria CV has received breakthrough device designation from the US Food and Drug Administration (FDA) for its medical device to treat pulmonary arterial hypertension (PAH).
PAH is a progressive disorder characterised by high blood pressure in the arteries of the lungs (pulmonary artery) that may lead to cardiac arrest.
Aria CV PH System is designed to reduce cardiac workload and enhance blood flow
Aria CV’s pulmonary hypertension system (Aria CV PH System) is an implantable device that is designed to restore healthy, elastic pulmonary arteries to reduce cardiac workload and improve blood flow.
The advantages of the system can improve the duration and quality of life for patients.
Aria CV CEO and president Dan Gladney said: “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.”
Aria scientific advisory board member and Mount Sinai Heart Health System academic affairs director Gregg Stone said: “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.”
Headquartered in Minnesota, US, Aria is currently readying for a US clinical trial under FDA’s early feasibility study Programme to evaluate long term implants in PAH patients.
The company, which was founded in 2010, is said to have carried out a successful acute first in a human clinical study in Vienna, Austria.