BALTIMORE, May 17, 2016 (GLOBE NEWSWIRE) -- Positive results of a clinical study of the C-Port® Distal Anastomosis System from Cardica, Inc. (Nasdaq:CRDC) were presented today at the Annual Meeting of the American Association for Thoracic Surgery (AATS) by Husam Balkhy, M.D., associate professor of Surgery and director of Robotic and Minimally Invasive Cardiac Surgery at The University of Chicago’s Medicine & Biological Sciences Division.
The MAGIC (Multicenter Assessment of Grafts in Coronaries) Study, a long-term post-market evaluation of the C-Port device, examined acute-to-mid-term and long-term vein graft occlusion rates for coronary revascularization using the C-Port compared to hand-sewn anastomoses. Patients receiving at least one C-Port anastomosis during coronary artery bypass grafting (CABG) surgery were enrolled at eight sites in the United States.
Results of the study indicated that the C-Port device is safe and effective when used to create the distal anastomosis in CABG surgery, with equivalent patency rates to hand-sewn grafts at 12 months. “When compared to hand-sewn anastomoses in a comparable population in a recent large prospective trial, the C-Port device demonstrated a statistically significant reduction in long-term graft occlusion rates,” Dr. Balkhy said.
Dr. Balkhy has performed an extraordinary number of robotic beating-heart, totally endoscopic coronary artery bypass, sometimes known at TECAB, procedures completed with Cardica’s C-Port Flex-A® – almost 500 since 2008. During these procedures, Dr. Balkhy has completed over 800 endoscopic anastomoses on the beating heart with the C-Port Flex-A device. “About 65 percent of my cases have been multi-vessel procedures, and this would not be possible on the beating heart if it were not for the Flex-A device,” he said. “C-Port is a breakthrough approach to performing coronary bypass surgery.”
Of the 117 patients enrolled in the MAGIC study (intent to treat population: ITT), 78 patients with 104 C-Port vein grafts completed the study to patency assessment via CT scanning (per protocol population: PP). Clinical follow-up and index graft patency were performed at least 12 months following surgery. The primary efficacy endpoint was graft patency compared to a performance goal established using the peer-reviewed results from the PREVENT IV trial, which studied the efficacy and safety of the E2F transcription factor decoy edifoligide. The primary safety endpoint was MACE (death, myocardial infarction or target vessel revascularization) rate at mid-term and long-term (12 months).
The ITT group had an overall mortality at 12 months of 0.8% (1/117) and a MACE rate of 4.3% (5/117). Only two of these MACE events occurred in patients who were included in the PP population, and both patients had patent grafts. The C-Port vein graft occlusion rate was 16.3% (PP population), compared to 26.6% in the PREVENT IV trial. The C-Port arterial graft occlusion rate was equivalent to the PREVENT IV trial. There were no significant differences in the occlusion rate between the C-Port vein grafts, 16.3%, and the hand-sewn vein grafts, 14.9%, within the MAGIC study.
“The results of The Magic Study confirm the innovative success of C-Port, even in very small coronary arteries,” said Julian Nikolchev, president and CEO of Cardica. “We applaud Dr. Balkhy’s dedication to innovation for the benefit of his patients and are thrilled that C-Port has played an important role in hundreds of his totally endoscopic coronary artery bypass procedures.”
About the C-Port® Distal Anastomosis Systems (C-Port systems)
The C-Port systems – the C-Port xA system and the Flex-A® system – can be used on- or off-pump and create compliant anastomoses that expand and contract with blood flow. With miniature stainless steel staples to secure the bypass graft to the coronary artery, C-Port reduces time required for anastomosis, which can be completed in two minutes. The C-Port systems work on coronary arteries as small as 1.25 millimeters in internal diameter and work with grafts of various diameters and wall thicknesses less than 1.4 millimeters. The Flex-A system allows surgeons to position the device to create a secure connection even in the most difficult to reach areas of the heart.
Cardica designs and manufactures proprietary stapling and automated 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 56,500 units throughout the world. In addition, Cardica’s MicroCutter XCHANGE® 30, the world’s smallest-profile articulating stapler, is manufactured and cleared for use in the U.S. for transection and resection in multiple open or minimally invasive urologic, thoracic and pediatric surgical procedures, as well as application for transection, resection and/or creation of anastomoses in the small and large intestine and the transection of the appendix.
The statements in this press release regarding Cardica’s beliefs as to the confirmation of the innovative success of C-Port Flex-A in very small coronary arteries are "forward-looking statements." There are a number of important factors that could cause such results to differ materially from those indicated by these forward-looking statements, including: that the C-Port Flex-A may be unsuccessful if used in very small coronary arteries as well as the 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 December 31, 2015, under the caption “Risk Factors,” filed on February 10, 2016. 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.