Simpson Interventions Accepted into FDA’s TAP Pilot Program for Breakthrough Device, Acolyte™ Catheter System

CAMPBELL, Calif.–(BUSINESS WIRE)–Simpson Interventions, Inc., a pioneering medical technology company specializing in cardiovascular interventional devices, today announced its acceptance into the Total Product Life Cycle Advisory Program Pilot (TAP Pilot) by the Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA).

Only devices granted Breakthrough Device designation by the FDA may apply to enroll in the TAP Pilot Program. This voluntary program is designed to help ensure U.S. patients have access to high-quality, safe, effective, and innovative medical devices by promoting early, frequent, and strategic communications between the FDA and medical device sponsors. Simpson Intervention’s Acolyte Catheter System was recently designated as a Breakthrough Device on March 4, 2024.

The Acolyte Catheter System is a cutting-edge technology, intended to facilitate the placement and positioning of guidewires and catheters within the coronary vasculature for the treatment of patients with coronary chronic total occlusions (CTOs), with persistent symptoms, following medical therapy. 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.

“Simpson Interventions is honored to be accepted into the FDA’s TAP Pilot Program for our Acolyte Catheter System,” said Dr. John B. Simpson, Ph.D., M.D., founder and CEO of Simpson Interventions. “This acknowledgment underscores the innovative nature of the device and its potential to address an unmet medical need in the field of interventional cardiology. We look forward to working closely with the FDA to advance the development and commercialization of this breakthrough technology.”

Simpson Interventions remains steadfast in its mission to bring transformative medical technologies to market, and the acceptance into the TAP Pilot Program marks a significant milestone in this journey.

For more information about Simpson Interventions and its innovative medical technologies, please visit www.simpsonint.com.

About Simpson Interventions:

Simpson Interventions is a leading 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.

For more information: www.simpsonint.com

Contacts

Steve Kelly

Simpson Interventions

Email: stevek@simpsonint.com