Simpson Interventions Shadow Catheter Cleared by FDA, Acolyte Catheter Receives IDE Approval

January 7, 2025—Simpson Interventions, Inc. announced that its Shadow catheter received FDA 510(k) clearance and its Acolyte image-guided crossing and re-entry catheter system has been granted an FDA investigational device exemption.

According to the company, the single-use/disposable Shadow catheter is indicated for interventional cardiology procedures and intended to be used in conjunction with steerable guidewires to access discrete regions of the coronary and peripheral arterial vasculature. This access facilitates placement and exchange of guidewires and other interventional devices for use during procedures, permitting simultaneous use of two guidewires and/or to subsequently infuse or deliver diagnostic or therapeutic agents. The clearance paves the way for the device’s commercialization, noted the company.

Simpson Interventions stated that the Acolyte system is intended to provide interventional cardiologists with a reliable and predictable tool to facilitate revascularization of coronary chronic total occlusions.

In April 2024, the company announced that the Acolyte system received FDA Breakthrough Device designation. In May 2024, Simpson Interventions announced its acceptance into the FDA Center for Devices and Radiological Health’s Total Product Life Cycle Advisory Program Pilot (TAP Pilot), which promotes frequent strategic communication between FDA and medical device sponsors.

The company also advised that William N. Starling joined its Board of Directors in October 2024. The release further advised William Starling’s 46 years of medical device experience includes being Cofounder and Managing Director of Synergy Life Science Partners and serving as CEO of Synecor LLC, a business generator of life science companies, from 2000 to 2024. Starling was a cofounder of several companies and oversaw the acquisition of others.