FDA Admits Simpson Interventions Into its TAP Pilot Program

Simpson Interventions Inc. has been accepted into the Total Product Life Cycle Advisory Program Pilot (TAP Pilot) by the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH).
 
Only devices granted Breakthrough Device designation by the FDA can apply for TAP Pilot Program enrollment. The voluntary program aims to help ensure U.S. patients have access to high-quality, safe, effective, medical devices by promoting early, frequent, and strategic communications between the FDA and medical device sponsors. The FDA designated Simpson Intervention’s Acolyte Catheter System as a Breakthrough Device earlier this year.
 
The Acolyte Catheter System helps physicians place and position guidewires and catheters within the coronary vasculature when treating patients suffering from coronary chronic total occlusions (CTOs) with persistent symptoms. By providing real-time visualization of coronary CTOs, the Acolyte Catheter System allows for precise guidewire placement and subsequent revascularization, improving patient outcomes and enhancing the standard of care, according to the company.
 
“Simpson Interventions is honored to be accepted into the FDA’s TAP Pilot Program for our Acolyte Catheter System,” Simpson Interventions Founder/CEO Dr. John B. Simpson, Ph.D., M.D., said. “This acknowledgment underscores the innovative nature of the device and its potential to address an unmet medical need in interventional cardiology. We look forward to working closely with the FDA to advance the development and commercialization of this breakthrough technology.”
 
Simpson Interventions is a medical technology company committed to addressing unmet clinical needs in cardiovascular diseases through technological innovations in visual-guidance, enhanced intelligence, and electromechanical automation for minimally invasive percutaneous intervention. The firm is headquartered in Campbell, Calif.