Simpson Interventions has reached significant development milestones in the field of cardiovascular interventional devices. The company’s innovative Acolyte™ Image-Guided Crossing and Re-Entry Catheter System has been granted an Investigational Device Exemption (IDE) by the U.S. Food and Drug Administration (FDA).
This follows its earlier designation as a Breakthrough Device in 2024. Additionally, the company’s Shadow Catheter™ has received 510(k) clearance from the FDA, allowing for its commercial use.
The Acolyte™ System is designed to provide interventional cardiologists with a reliable tool for revascularising coronary chronic total occlusions (CTOs). CTOs are a common condition in patients with coronary artery disease and are often managed through medical treatment or bypass surgery.
The IDE approval permits the device to be used in clinical studies to collect data on its safety and effectiveness. Approval of an IDE is a prerequisite for conducting clinical evaluations of investigational devices unless exempted.
The Acolyte™ System’s Breakthrough Device Designation (BDD) was granted in March 2024, enabling its participation in the FDA’s Total Product Life Cycle Advisory Program Pilot (TAP Pilot).
This programme is designed to facilitate strategic communication between the FDA and medical device developers, providing support throughout the product lifecycle.
Simpson Interventions’ Shadow Catheter™ has also achieved 510(k) clearance, which is a key step towards its commercial availability. This single-use catheter is intended for use in interventional cardiology procedures. It works with steerable guidewires to access specific areas of the coronary and peripheral arterial vasculature.
This enables the placement and exchange of guidewires and other interventional devices during procedures. Additionally, the Shadow Catheter™ allows for the simultaneous use of two guidewires or the delivery of diagnostic or therapeutic agents.
These milestones reflect Simpson Interventions’ commitment to advancing interventional cardiology with innovative solutions that enhance the efficiency and effectiveness of medical procedures. The Acolyte™ System and Shadow Catheter™ exemplify the company’s dedication to improving patient care through cutting-edge technology.
Source: https://www.businesswire.com/news/home/20250107441702/en
