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News

Cardica submits 510(k) notification for PAS-Port cardiac bypass system

Cardica : 30 April, 2008  (New Product)
Cardica’s PAS-Port Proximal Anastomosis System has achieved its primary endpoint in a large, prospective, randomised pivotal clinical trial comparing graft vessel connections made using the PAS-Port system to conventional hand-sewn sutures during coronary artery bypass graft (CABG) procedures.
Based on the positive data from the trial, Cardica submitted a 510(k) premarket notification to the US FDA for the PAS-Port system. The PAS-Port system, which is commercially available in Japan and Europe, creates a secure connection, or anastomosis, between a vein Graft and the aorta, the main artery in the human body, during bypass procedures.

'The innovative design of the PAS-Port system allows surgeons to consistently and reliably attach a Graft vessel to the aorta, generally in about two minutes,' said Bernard A Hausen, MD, PhD, president and chief executive officer of Cardica. 'The PAS-Port system complements our marketed C-Port system, and subject to receiving clearance of the PAS-Port system from the FDA, we will be able to provide surgeons with a complete suite of reliable automated revascularization systems for use in CABG procedures.'

Cardica conducted the 220-patient pivotal, prospective, randomised trial at 12 sites in the USA and Europe. The primary endpoint of the trial was non-inferiority of the patency of the PAS-Port Graft compared to the hand-sewn Graft nine months following the CABG procedure. The PAS-Port system met the primary efficacy endpoint of non-inferiority in patency at nine-month follow up compared to hand-sewn anastomoses. Trial results will be presented at future medical meetings.

In the trial, two venous bypass grafts were randomly selected in each patient to be connected to the aorta. The PAS-Port system was used for one Graft and the conventional hand-sewn technique for the other, for a total of 440 randomised grafts. Patients were scheduled to receive a follow-up angiogram nine months after their index procedure to determine patency (or degree of openness of the vein graft) for both the PAS-Port and control grafts. Over 90 percent of the patients received these angiograms.

The trial design and endpoints reflect guidance received following the April 2005 FDA panel meeting regarding the PAS-Port system. The analysis and endpoints of the clinical trial results are consistent with the FDA approved protocol and statistical analysis plan. During the pivotal trial, the customary FDA inspections validated Cardica's good clinical practices and data collection methods under FDA guidelines.

'I would like to thank the investigators and patients who participated in this landmark trial for their excellent compliance in follow-up angiographies,' continued Dr Hausen. 'We believe the robust data generated in this trial help to further establish the long-term safety and efficacy of our PAS-Port system.'

The innovative design of the PAS-Port system allows a surgeon to load the bypass Graft into the system and rapidly complete the anastomosis, typically in approximately two minutes, with little or no injury to the bypass Graft vessel or the aorta. Importantly, the PAS-Port system eliminates the need to clamp the aorta during CABG procedures.

More than 8,000 PAS-Port systems had been sold in Japan and Europe, and according to Cardica's distributor, today this product is used in more than 20 percent of all proximal anastomoses performed using a vein bypass Graft during CABG surgeries in Japan.
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