Simpson Interventions' Acolyte™ Image-Guided Crossing and Re-Entry Catheter System Granted FDA Breakthrough Device Designation

Friday, April 12, 2024

Simpson Interventions, a prominent medical technology company specializing in cardiovascular interventional devices, has announced a significant achievement: its pioneering Acolyte Image Guided Crossing and Re-Entry Catheter System has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA).

This designation marks a significant advancement in the treatment of patients with coronary chronic total occlusions (CTOs) who have not experienced relief through traditional medical therapy. The Acolyte system is specifically designed to enhance the placement and positioning of guidewires and catheters within the coronary vasculature. It utilizes real-time optical coherence tomography (OCT) visualization to enable precise guidewire placement within the target vessel's true lumen, thereby facilitating subsequent revascularization procedures.

Breakthrough Device Designation from the FDA is reserved for medical devices offering potential advantages over existing technologies for the treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. This designation expedites the development, assessment, and review process, ultimately allowing patients faster access to innovative medical technologies.

Simpson Interventions is committed to collaborating closely with the FDA and other stakeholders to advance the development and regulatory review of the Acolyte Image Guided Crossing and Re-Entry Catheter System. The company is eager to introduce this revolutionary technology to clinicians and patients in need, with the aim of improving outcomes and quality of life for those dealing with coronary CTOs.






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