Simpson Interventions' Acolyte™ Catheter System Joins FDA's TAP Pilot Program for Breakthrough Devices

Thursday, May 16, 2024

Simpson Interventions, a pioneering medical technology company specializing in cardiovascular interventional devices, 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 may apply to enroll in the TAP Pilot Program.

This voluntary initiative aims to foster early, frequent, and strategic communication between the FDA and medical device sponsors to ensure American patients have access to high-quality, safe, effective, and innovative medical devices.

The Acolyte Catheter System developed by Simpson Interventions received Breakthrough Device designation on March 4, 2024.

The Acolyte Catheter System is an advanced technology designed to assist in the placement and positioning of guidewires and catheters within the coronary vasculature for treating patients with coronary chronic total occlusions (CTOs) who exhibit persistent symptoms despite medical therapy.

With real-time visualization of coronary CTOs, the Acolyte Catheter System enables precise guidewire placement and subsequent revascularization, ultimately enhancing patient outcomes and raising the standard of care.

The device's innovative nature and its potential to address an unmet medical need in interventional cardiology.

Simpson Interventions is eager to collaborate closely with the FDA to advance the development and commercialization of this groundbreaking technology.

This milestone of acceptance into the TAP Pilot Program underscores Simpson Interventions' unwavering commitment to introducing transformative medical technologies to the market.





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