Gradient Denervation Technologies, a medical device company focused on treating pulmonary hypertension (PH) in heart failure patients, has appointed Stanton Rowe to its board of directors and received FDA approval to expand its early feasibility study. The moves signal significant progress for the Paris-based company as it develops its ultrasound-based catheter system.
New Leadership on Board
Stanton Rowe, a seasoned medical device entrepreneur, joins Gradient's board. Rowe's experience includes developing innovative medical technologies through Nidus Biomedical and NXT Biomedical. He previously served as Chief Scientific Officer of Edwards Lifesciences and co-founded Percutaneous Valve Technologies, which developed the first transcatheter aortic valve replacement (TAVR) device.
"I’m very excited to join Gradient and work with the company to bring this technology to patients," said Rowe. "Gradient’s early experience with pulmonary denervation is promising and I see great potential for this system to provide a new treatment option for these underserved patients."
FDA Approves Trial Expansion
The FDA has approved the expansion of Gradient's PreVail-PH2 Early Feasibility Study, based on initial cohort results. The study is actively enrolling patients with WHO Group 2 Pulmonary Hypertension at centers in the United States and is recruiting additional clinical centers with heart failure and pulmonary hypertension expertise.
The PreVail-PH2 study is evaluating Gradient's minimally invasive, ultrasound-based catheter system. The device targets pulmonary artery denervation as a potential treatment for pulmonary hypertension in patients with heart failure. Pulmonary hypertension, particularly WHO Group 2, represents a significant clinical challenge, often associated with poor outcomes and limited treatment options.
About Gradient's Technology
Gradient Denervation Technologies is developing a minimally invasive device for treating pulmonary hypertension in patients with heart failure, leveraging intellectual property developed at Stanford University. The Gradient device is for investigational use only and is not approved for commercial use anywhere in the world.
"Gradient is at a critical point in our development as we build our clinical experience with our ultrasound-based pulmonary artery denervation technology," said Martin Grasse, Gradient’s CEO. "I’m delighted to have Stan joining us and am looking forward to leveraging his deep experience to help guide the company in our next phase."
