Simpson Interventions Accepted Into FDA’s TAP Pilot Program for Breakthrough Devices

May 22, 2024—Simpson Interventions, Inc. recently announced its acceptance into the FDA Center for Devices and Radiological Health’s Total Product Life Cycle Advisory Program Pilot (TAP Pilot).

According to the company, TAP Pilot is a voluntary program designed to help ensure that patients in the United States 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.

The company noted that only devices that have been granted FDA Breakthrough Device designation are eligible to apply to enroll in the TAP Pilot.

In April 2024, Simpson Intervention announced that its Acolyte catheter system received the Breakthrough Device designation. Acolyte provides real-time visualization of coronary chronic total occlusions to facilitate the placement and positioning of guidewires and catheters within the coronary vasculature, stated the company.