First Robotic-Assisted System for PCI Receives FDA Clearance

Corindus Vascular Robotics recently declared that its CorPath 200 System has achieved FDA 510(k) clearance for effective use in percutaneous coronary interventions (PCI).

The technology has gained approval in the U.S. Interventional cardiologists can now precisely perform PCI. This PCI procedure will be conducted for those affected with coronary artery disease (CAD) for blood flow restoration in their blocked arteries.

Catheterization and Cardiovascular Intervention journal featured the latest data, which illustrated that an interventional cardiologist is exposed to occupational health risks such as cataracts, orthopedic problems, and cancer when subjected to continuous exposure to radiation and the inherent physical stresses existing in the cath lab. Hence, a single-arm, multi-center study called “CorPath PRECISE Trial” functions as a platform supporting the assent of a pre-market clearance (510(k)) application to the FDA. It highlighted the safety and practical feature of robotically-assisted PCI. PCI procedure was successfully conducted in around 98.8 % of patients without any device-related complexities, eliminating the need for conversion to manual PCI. The success rate was 97.6% for overall procedure. The trial ensured the safe implementation of robotic-assisted PCI procedure. The CorPath 200 System-based PCI procedure   showed 95% reduction in radiation exposure.

The CorPath 200 System is a unique robotic-assisted procedure. In this procedure, coronary guidewires and stent or balloon catheters are precisely controlled from an optimized interventional cockpit. The lead-lined cockpit offers safety to the interventional cardiologist against harmful radiation exposure. By sitting in a position facing the monitors, surgeons can clearly visualize the angiography screen with comfort and ease.

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