Simpson Interventions Wins FDA & IDE Nods for Cardiovascular Intervention Devices

Simpson Interventions, a company specializing in cardiovascular interventional devices, has reached a pair of major development milestones.

The company’s Acolyte image-guided crossing and re-entry catheter system was awarded investigational device exemption (IDE) from the U.S. Food and Drug Administration (FDA), following designation as a breakthrough device last year. Simpson’s Shadow catheter has also received FDA 510(k) clearance.

Acolyte provides a reliable, predictable tool to facilitate revascularization of coronary chronic total occlusion (CTO). According to the company, a significant percentage of patients with coronary artery disease have CTOs, whether managed medically or referred for bypass surgery. Acolyte can now be used in a clinical study to gather data on safety and effectiveness.

The system won breakthrough device status and was accepted into the FDA’s Total Product Life Cycle Advisory Program Pilot (TAP Pilot), both in March of 2024.

The newly 510(k)-cleared Shadow catheter is single-use/disposable and used in interventional cardiology procedures, in conjunction with steerable guidewires to access discrete areas of the coronary and peripheral arterial vasculature. According to Simpson, this facilitates’ placing and exchanging guidewires and other interventional devices, allowing simultaneous use of two guidewires and/or to subsequently infuse or deliver diagnostic or therapeutic agents.

“Receiving IDE approval of the Acolyte System, which we believe is groundbreaking in helping physicians treat patients with CTO, was a tremendous accomplishment for Simpson Interventions,” said Dr. Joseph Knight, CEO of Simpson Interventions. “To additionally receive 510(k) clearance for our Shadow Catheter, which not only helps with wire exchanges but also aids in accessing side branches, is further proof that our company continues to innovate in the arena of interventional cardiology with tools to help interventional cardiologists be more efficient and effective in treating their patients.”

Dr. Knight was hired as Simpson’s chief executive in July 2024, succeeding founder and former chief executive John B. Simpson, Ph.D., MD

The company also added William N. Starling to its board in October 2024. Starling was previously co-founder and managing director of Synergy Life Science Partners and CEO of Synecor from 2000-2024.