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News

Cardica completes enrollment in long-term study of distal anastomosis systems

Cardica : 24 January, 2013  (Company News)
Cardica completes enrollment in the Multicentre Assessment of Grafts in Coronaries (MAGIC) trial, the company's post market surveillance study for the long-term evaluation of bypass grafts completed using C-Port Distal Anastomosis Systems.


Cardica's C-Port systems are automated stapling devices used to connect graft vessels during a heart bypass procedure.



"The long-term evaluation of the C-Port systems is expected to provide solid data surrounding the use of this device to perform an automated anastomosis during bypass procedures," said Dr Husam Balkhy, Associate Professor of Surgery Medical College of Wisconsin, director, Center for Robotic and Minimally Invasive Cardiac Surgery at the Wisconsin Heart Hospital and principal investigator of the trial. "Having used the C-Port systems regularly over the last several years, I can confidently say that this device allows surgeons to connect vessels in a reliable, repeatable way, and facilitates the use of less invasive bypass procedures to minimize recovery time and improve outcomes."



The study, which enrolled 115 patients at seven primary sites in the United States, will evaluate the patency, or openness, of bypass graft vessels 12 months following a coronary artery bypass graft (CABG) procedure. The trial is designed as a prospective, multi-centre, open-label study. The graft occlusion rates for commercialized C-Port devices are being compared to an a priori rate taken from the published results of the PREVENT IV clinical trial, which evaluated one year patency in more than 3000 patients following coronary artery bypass graft procedures.



"We are pleased to complete enrollment in this confirmatory trial for our C-Port systems, as we believe our automated cardiac devices facilitate less invasive cardiac procedures, and with increased exposure to the product, additional surgeons may adopt this unique product to benefit their patients," commented Bernard Hausen, President and Chief Executive Officer of Cardica.


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