Simpson Interventions, a pioneer in medical technology specializing in cardiovascular interventional devices, has announced that its groundbreaking Acolyte Image Guided Crossing and Re-Entry Catheter System has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA).
The system is designed to aid in the placement and positioning of guidewires and catheters within the coronary vasculature for patients with coronary chronic total occlusions (CTOs) who continue to experience symptoms despite medical therapy.
By offering real-time optical coherence tomography (OCT) visualization, the Acolyte system enables precise guidewire placement within the true lumen of the target vessel, facilitating subsequent revascularization.
Coronary CTOs affect a significant portion of patients with coronary artery disease, presenting challenges for interventional cardiologists. Current standard treatments often struggle to navigate these blockages, leading to limited options and, in some cases, bypass surgery.
FDA's recognition the technology, highlighting its potential to address critical unmet needs in treating coronary chronic total occlusions.
The FDA's Breakthrough Device Designation is granted to medical devices that offer significant advantages over existing technologies for treating or diagnosing life-threatening or debilitating conditions.
This designation expedites the development and review process, ensuring faster access to innovative medical technologies for patients.
Source: https://www.businesswire.com/news/home/20240411497717/en/Simpson-Interventions-Receives-FDA-Breakthrough-Device-Designation-for-Acolyte%E2%84%A2-Image-Guided-Crossing-and-Re-Entry-Catheter-System
