Anastomosis System for Cardiac Bypass Introduced After Clearance
The PAS-Port Proximal Anastomosis System from Cardica received marketing clearance from the Food and Drug Administration. The system is indicated for use during cardiac bypass surgery; it was already approved for use in both Europe and Japan.
The PAS-Port supports creation of anastomosis between the aorta and vein graft during coronary artery bypass grafting. Surgeons can complete automated proximal anastomosis without needing to clamp nor manipulate the aorta. This approach can reduce the potential for complications associated with clamping.
Data indicates that removing the need for the clamp particularly decreases the risk of particle release which may result in neurocognitive events. Particles that are released include tiny blood clots and particles which can travel to the brain, causing events such as stroke.
Additional advantages offered by the system include a fully automated integrated tool. Anastomosis can be rapidly completed with a preloaded bypass graft. The time to complete anastomosis with the PAS-Port is decreased compared to traditional, hand sewn anastomosis.
Loading of the graft does not damage the endothelial cells and still maximizes the orifice, which is critical in smaller grafts. These features support a reliable and consistent connection. Patient benefits may include shortened time to complete the procedure and abbreviated hospital stay.
Cardica completed a prospective, randomized trial that included 220 patients. The study compared venous bypass graft vessel connections with the aorta with the PAS-Post compared to hand suturing. Results indicated non-inferiority of the PAS-Port system compared to hand sewn systems.
September 12, 2008 Related topics: Product Approval & Certification, New Technology & Innovation, Cardiology