Cardica begins clinical trial of PAS-Port anastomosis system in coronary artery bypass graft surgery

By Lisa Kerner

Charlotte, N.C., June 27 - Cardica, Inc. said it started a pivotal clinical trial to evaluate the safety and efficacy of its PAS-Port Proximal Anastomosis System during coronary artery bypass graft (CABG) surgery.

The pivotal, prospective, randomized trial of 220 patients is being conducted at 10 sites in Europe and the United States.

Each patient will receive a PAS-Port, which creates a secure connection between a vein graft and the aorta (anastomosis), as well as a hand-sewn anastomosis.

All patients will receive a follow-up angiogram after nine months to determine the degree of openness of the vein graft (or patency).

"This trial is intended to demonstrate that the PAS-Port system will provide a proximal anastomosis that is at least as good as hand-sewn sutures," the lead investigator of the study, John D. Puskas, said in a company news release.

"The PAS-Port system's ability to facilitate beating heart bypass surgery may reduce the risk of neurological complications and mortality associated with clamping the aorta during beating heart procedures."

Previous clinical trials in Europe demonstrated a six-month patency rate using the PAS-Port system from 87% to 98% compared to the traditional average of 84% for hand-sewn anastomoses.

Redwood City, Calif.-based Cardica designs and manufactures automated anastomosis systems for coronary artery bypass graft surgery.

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