Gradient Denervation Technologies announced today that its pulmonary denervation system has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA). This program allows for expedited review for devices that may offer more effective treatment for serious or disabling conditions while meeting the FDA's strict standards for safety and effectiveness.

The Gradient Denervation System is a novel technology for the treatment of patients with pulmonary hypertension and associated heart failure. The treatment involves ablation of the nerves around the pulmonary artery using therapeutic ultrasound in a minimally invasive percutaneous procedure. The single catheter platform has been specifically designed to fit the anatomy of the pulmonary artery and is based on proven interventional techniques. The treatment goal is to reduce sympathetic activity in the pulmonary vascular tree to decrease vascular resistance and pulmonary pressure.  

The PreVail-PH2 early feasibility study is currently enrolling patients with pulmonary hypertension due to left-sided heart disease, classified by the World Health Organization (WHO) as pulmonary hypertension group 2. Up to two-thirds of heart failure patients worldwide have elevated pulmonary vascular resistance, increasing the risk of mortality and hospitalization. There are currently no drugs or medical devices approved in the United States to treat this group of patients with pulmonary hypertension.

“We are pleased with this positive response from the FDA. The granting of Breakthrough Device Designation represents an important milestone for our clinical development program for the pulmonary denervation system,” said Martin Grasse, Chairman and CEO of Gradient. “We remain focused on completing our early feasibility study, which is a critical first step toward a targeted treatment that could improve outcomes and quality of life for these underserved patients.”

 

Source: globenewswire.com

Report Abuse