Simpson Interventions' Acolyte Catheter System Receives IDE Approval, Shadow Catheter Cleared by FDA
核心洞察
Simpson Interventions (搜索)' Acolyte System (搜索), designed for coronary chronic total occlusion (搜索) revascularization, has received FDA Investigational Device Exemption (IDE).
The FDA also granted 510(k) clearance to Simpson Interventions (搜索)' Shadow Catheter (搜索), facilitating its commercialization for interventional cardiology procedures.
The Acolyte System (搜索) previously received Breakthrough Device Designation and was accepted into the FDA's TAP Pilot Program in March 2024.
Simpson Interventions (搜索), Inc. has achieved significant milestones with its Acolyte Image-Guided Crossing and Re-Entry Catheter System receiving Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration (FDA), and its Shadow Catheter (搜索) securing 510(k) clearance. The Acolyte system (搜索) aims to improve the revascularization of coronary chronic total occlusions (CTO), while the Shadow Catheter is designed for use in interventional cardiology procedures.
The Acolyte System (搜索)'s IDE approval allows for clinical studies to collect safety and efficacy data, marking a crucial step toward full clearance. CTOs are present in a notable percentage of patients with coronary artery disease (搜索), whether they are managed medically or referred for bypass surgery. The Acolyte System received Breakthrough Device Designation (BDD) from the FDA and was accepted into the Total Product Life Cycle Advisory Program Pilot (TAP Pilot) in March 2024, which facilitates strategic communication between the FDA and medical device sponsors.
The Shadow Catheter (搜索)'s 510(k) clearance paves the way for its commercial launch. This single-use catheter is indicated for interventional cardiology and is intended for use with steerable guidewires to access specific areas of the coronary and peripheral arterial vasculature. It supports the placement and exchange of guidewires and other interventional devices, allowing for the simultaneous use of two guidewires or the infusion of diagnostic or therapeutic agents.
"Receiving IDE approval of the Acolyte System (搜索), which we believe is groundbreaking in helping physicians treat patients with CTO, was a tremendous accomplishment for Simpson Interventions (搜索)," said Dr. Joseph Knight, Chief Executive Officer of Simpson Interventions. "To additionally receive 510(k) clearance for our Shadow Catheter (搜索), 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."
William N. Starling Joins Board of Directors
In October 2024, William N. Starling joined Simpson Interventions (搜索)' Board of Directors. Starling brings over 46 years of medical device experience, including his role as Co-founder and Managing Director of Synergy Life Science Partners and CEO of Synecor LLC from 2000 to 2024.