First Peer-Reviewed Publication Validating Cardica’s C-Port(R) Systems Efficacy in Beating-Heart Bypass Procedures Using Arterial Grafts
REDWOOD CITY, Calif., April 15 /PRNewswire-FirstCall/ — Cardica, Inc. (Nasdaq: CRDC) today announced the publication of a study demonstrating that the use of its anastomosis (stapling) devices provides a safe and effective means to connect arterial grafts during beating-heart coronary artery bypass graft (CABG) procedures. The study, which was published in the March/April issue of the official journal of the International Society of Minimally-Invasive Cardiothoracic Surgery, Innovations, evaluated the safety and efficacy of Cardica’s C-Port xAÃ‚® Distal and Flex-AÃ‚® Anastomosis Systems (C-Port xA and Flex-A) during beating-heart coronary artery bypass graft (CABG) procedures. Results showed that Cardica’s anastomosis systems connected arterial grafts consistently and effectively during bypass procedures performed on a beating heart without the use of a heart-lung machine, and that these grafts remained open in short and mid-term follow-up.
According to the study, the C-Port xA and Flex-A stapling devices consistently and reproducibly connected an arterial graft with the push of a button in approximately two minutes. The specific connection of the internal mammary artery (IMA) to the left anterior descending artery (LAD) studied in the publication is considered the optimal connection for coronary bypass procedures. In follow-up analysis, 24 of the 25 total grafts were open (patent) as determined by 64 slice computerized tomography. In comparison, a meta analysis of 28,000 grafts completed with hand suturing showed that approximately 84% of those anastomoses remained patent at six months.
“This publication in Innovations validates the value of using an automated stapling device on the internal mammary artery graft when working on a beating heart, as it connects the artery with similar patency results to traditional hand-sewn anastomoses,” said study author Husam H. Balkhy, M.D., director of the Center for Minimally Invasive Cardiac and Robotic Surgery for The Wisconsin Heart Hospital, who also practices at several other hospitals in Milwaukee. “With the dynamic technologies available today, sternum-sparing, robotic cardiac surgery can provide direct benefits to the patient in reduced recovery time and better outcomes and to the hospital in substantial cost savings.”
Since the introduction of Cardica’s automated anastomosis systems in the United States, Dr. Balkhy has deployed more than 800 devices in over 400 patients, and has emerged as a world leader in the field of coronary connector surgery. “Primarily due to Cardica’s device, I have been able to move quickly from open beating-heart bypass procedures to single-vessel robotic CABG surgery and now to double and triple vessel bypasses using small pencil-diameter incisions,” continued Dr. Balkhy.
Earlier this year, Dr. Balkhy achieved a milestone, completing over 100 connector totally endoscopic coronary artery bypass (TECAB) procedures using the Cardica Flex-A systems in less than two years. Dr. Balkhy is one of the few surgeons in the United States performing multi-vessel TECAB surgeries using Cardica’s Flex-A system to attach blood vessels during closed-chest, completely robotic bypass procedures.
Patients have come to Milwaukee from across the country to undergo multi-vessel connector TECAB procedures performed by Dr. Balkhy. During the procedure, Dr. Balkhy guides Intuitive Surgical, Inc.’s da VinciÃ‚® Surgical System to perform precise movements through micro incisions in the chest area similar to the procedure used for minimally invasive abdominal surgery, while the heart continues to beat. In contrast, conventional “open-chest” CABG surgeries are performed by cutting the sternum. Minimally-invasive direct coronary artery bypass, or “MIDCAB” procedures, are performed by cutting an opening between ribs, and then spreading the rib cage.
On average, patients who receive open-chest CABG procedures stay in the hospital five to seven days and may require up to three to four months to return to normal activities. Dr. Balkhy’s patients undergoing multi-vessel connector TECAB procedures may be discharged in 48 to 72 hours following surgery, and often return to normal activity levels within two to three weeks. Shortened intensive care unit and overall hospital stays result in cost savings for both the patient and the hospital.
“Dr. Balkhy pioneered the multi-vessel connector TECAB procedure using the da Vinci robot together with our C-Port Flex-A system,” said Bernard A. Hausen, M.D., Ph.D., president and chief executive officer of Cardica. “While other surgeons are using the robot to take down the mammary artery in preparation for bypass surgery, the actual procedure generally is still performed through either a MIDCAB or open chest procedure. In contrast, Dr. Balkhy’s experience and expertise performing the entire multi-vessel procedure without opening the chest is setting new standards for the future of robotic bypass surgery. As our automated anastomosis systems continue to facilitate minimally-invasive cardiac surgery, surgeons like Dr. Balkhy are instrumental in driving change to help improve patient outcomes through these novel technologies.”
Cardica designs and manufactures proprietary stapling devices for cardiac and endoscopic surgical procedures. Cardica’s stapling technology minimizes operating time and enables minimally-invasive and robot-assisted surgeries. Cardica manufactures and markets its automated anastomosis systems, the C-Port(R) Distal Anastomosis Systems and PAS-Port(R) Proximal Anastomosis System, for coronary artery bypass graft (CABG) surgery and has shipped over 27,000 units throughout the world.. In addition, the company is developing the Cardica Microcutter ES8, a true multi-fire endoscopic stapling device designed to be used in a variety of procedures, including bariatric, thoracic and general surgery.
This press release contains “forward-looking” statements, including all statements regarding the potential benefits of using Cardica’s distal anastomosis systems. Any statements contained in this press release that are not historical facts may be deemed to be forward-looking statements. The words “can,” “result,” “improve,” and similar expressions are intended to identify 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’s current and any future products may never gain any significant degree of market acceptance, that patient outcomes are variable and may not reflect results demonstrated in the study, 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 fiscal quarter ended December 31, 2009. 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.