Clamp-Free Anastomosis Device for Vein Grafts

An innovative handheld device creates an anastomosis between a vein graft and the aorta during coronary artery bypass graft (CABG) surgery, without conventional sutures or the need for arterial clamping.

The PAS-Port proximal anastomosis system is a fully automated device used to join a saphenous vein and the aorta during either on- or off-pump CABG surgery. The system is designed to allow the surgeon to load the bypass graft and rapidly complete the anastomosis, typically in approximately one minute, and eliminate aortic clamping and manipulation, which greatly reduces the risk of particle release and ensuing neurocognitive events. The system also provides one-turn aortotomy and anastomosis, reducing the time required for the procedure, and producing consistent, reproducible results largely independent of surgical technique and skill set. The system also ensures secure graft attachment, allowing for variable take-off angles; leaves no metal within the graft lumen; and can be loaded into the system without damaging endothelial cells while maximizing the orifice, especially important in small grafts.

To complete a proximal anastomosis, the cardiac surgeon loads the bypass graft vessel into the PAS-Port system, places the end of the delivery device against the aorta and turns the knob on the opposite end of the delivery tool. The device first creates an opening in the aorta and subsequently securely attaches the bypass graft to the aortic wall, using a medical grade stainless steel implant that is formed into its final shape by the delivery tool. The system allows the surgeon to load the bypass graft and complete the anastomosis in approximately three minutes, with little or no injury to the bypass graft vessel or the aorta. The PAS-Port system is a product of Cardica (Redwood City, CA, USA), and has been approved by the U.S. Food and Drug Administration (FDA). The system is also approved for sale and marketed in the European Community and in Japan.

"The PAS-Port system is associated with significant patient benefits compared with hand-sewn anastomoses,” said John Puskas, M.D., of Emory University (Atlanta, GA, USA). "Because the PAS-Port device can be used to create a proximal anastomosis without needing to clamp the aorta, it may ultimately improve patient outcomes by shortening surgery times and hospital stays and reducing complications associated with aortic clamping.”

Related Links:
Cardica
Emory University