anastomosis between a saphenous vein and the aorta during either on- or off-pump CABG surgery. The PAS-Port system has received 510(k) clearance in the United States and is approved for sale and marketed in Europe and Japan.

The PAS-Port system is designed to:

• Allow the surgeon to load the bypass graft and rapidly complete the anastomosis, typically in approximately one minute;
• Eliminate aortic clamping and manipulation. Eliminating clamping may greatly reduce the risk of particle release and ensuing neurocognitive events;
• Provide one-turn aortotomy and anastomosis;
• Reduce time required for anastomosis; 
• Produce consistent, reproducible anastomoses, largely independent of surgical technique and skill set;
• Ensure secure graft attachment allowing for variable take-off angles;
• Leave no metal within the graft lumen;
• Be loaded into the system without damaging endothelial cells while maximizing the orifice, which is especially important in small grafts; and
• Allow mechanically governed repeatability and reduced procedural complexity.

Pull Through		Eversion		Poke Through
The bypass vessel graft is pulled through the PAS-Port system in preparation for deployment.		The graft vessel is everted in preparation for deployment.		The vessel is prepared and ready to attach to the aorta.

PAS-Port System Met All Endpoints in Pivotal Trial

Cardica conducted a 220-patient, prospective, pivotal, randomized trial of the PAS-Port^® system at 12 sites in the United States and Europe. The trial compared venous bypass grafts to the aorta made using the PAS-Port system versus those made using conventional hand-sewn sutures. Results showed that the study met its primary endpoint of non-inferiority to hand-sewn anastomoses, as well as all other primary and secondary endpoints. 

The results of the EPIC trial have been published in the July 2009 issue of The Journal of Thoracic & Cardiovascular Surgery.  To request a copy of the published report, click here.  Follow the links below to read some of the press on this announcement or view the abstract.

The Journal of Thoracic and Cardiovascular Surgery

Cardica, Inc. Press Release

Diagnostic & Invasive Cardiology Magazine

For more information about Cardica products,
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