Cardica Completes Enrollment In Long-Term Evaluation Study Of Its C-Port® Distal Anastomosis Systems
REDWOOD CITY, Calif., Jan. 22, 2013 /PRNewswire/ -- Cardica, Inc. (Nasdaq: CRDC) today announced that the company has completed enrollment in the Multicenter Assessment of Grafts in Coronaries (MAGIC) trial, its 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 H. 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-center, 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 A. Hausen, president and CEO of Cardica.
Cardica designs and manufactures proprietary stapling and anastomotic devices for cardiac and laparoscopic surgical procedures. Cardica's technology portfolio is intended to minimize operating time and enable minimally-invasive and robot-assisted surgeries. Cardica manufactures and markets its automated anastomosis systems, the C-Port® Distal Anastomosis Systems and PAS-Port® Proximal Anastomosis System for coronary artery bypass graft (CABG) surgery, and has shipped over 42,900 units throughout the world. In addition, Cardica is developing the Cardica MicroCutter XCHANGE™ 30, a cartridge-based microcutter device with a five-millimeter shaft diameter, and the Cardica MicroCutter XPRESS™ 30, a true multi-fire laparoscopic stapling device. Both MicroCutter devices are designed to be used in a variety of procedures, including bariatric, colorectal, thoracic and general surgery. The Cardica MicroCutter XCHANGE 30 and XPRESS 30 products require 510(k) review and are not yet commercially available in the U.S.
The statements in this press release regarding Cardica's expectations with respect to the data to be received from the evaluation of the C-Port systems, Cardica's belief that its automated cardiac devices facilitate less invasive cardiac procedures, and that additional surgeons may adopt this product, are "forward-looking statements." The words "will," "believe," and "may" are intended to identify these forward-looking statements. There are a number of important factors that could cause Cardica's results to differ materially from those indicated by these forward-looking statements, including that Cardica may experience unexpected results in the evaluation of the C-Port systems which could make the data not reliable for evaluating the C-Port systems and could also cause additional surgeons not to adopt this product, and that competing products may be developed that are equally or less invasive for cardiac procedures than the C-Port systems which could also cause additional surgeons not to adopt this product, and that the C-Port systems may face development, regulatory, reimbursement and manufacturing risks; that Cardica's intellectual property rights may not provide adequate protection of this product; as well as other risks detailed from time to time in Cardica's reports filed with the U.S. Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the quarter ended September 30, 2012. Cardica expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein. You are encouraged to read Cardica's reports filed with the U.S. Securities and Exchange Commission, available at www.sec.gov.
SOURCE Cardica, Inc.
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