REDWOOD CITY, Calif., Jan. 26, 2012 /PRNewswire/ -- Cardica, Inc. (Nasdaq: CRDC) today announced that it has surpassed 25,000 deployments of its proprietary PAS-Port® Proximal Anastomosis System during on- and off-pump coronary artery bypass graft (CABG) surgeries. The PAS-Port system creates a secure connection, or anastomosis, between a vein graft and the aorta, the main artery in the human body, during CABG procedures and was first shipped to Japan and Europe in 2004 before receiving US FDA market clearance in September 2008.
"I use the PAS-Port System in all cardiac bypass procedures as it saves me time in the operating room and allows me to perform less invasive MIDCAB surgeries," said Darien Bradford, M.D., cardiothoracic surgeon at Texas Healthcare. "Importantly, this is the right tool for my patients as it is reliable and the grafts connected using the PAS-Port device have been shown in clinical studies to produce the same patency as hand sewn sutures."
The PAS-Portsystem allows a surgeon to complete an automated connection of the bypass graft vessel to the aorta (known as a proximal anastomosis) without the need to clamp and manipulate the aorta. The common method of completing a proximal anastomosis in CABG surgery often requires that the aorta be clamped and utilizes time-consuming hand-sewn sutures. When the clamp is released, tiny blood clots or particles from the aortic wall can be released, which can then travel to the brain and cause stroke and other neurologic complications. In addition, the PAS-Port's unique design allows for a comparable take-off angle when compared to hand-sewn sutures, and enables normal blood flow as the PAS-Port's implant design does not introduce metal into the lumen. "Since its international introduction in 2004 and FDA clearance in 2008, our PAS-Port system has been used by hundreds of surgeons to produce consistent, repeatable proximal anastomoses, with excellent clinical results," commented Bernard A. Hausen, M.D., Ph.D., president and chief executive officer of Cardica. "We are pleased to reach this important milestone and to continue to see the promise this product has to make cardiac surgery less invasive."
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 37,000 units throughout the world. In addition, Cardica is developing the Cardica MicroCutter XCHANGE™ 30, a cartridge-based microcutter device with a 5 millimeter shaft diameter, and the Cardica MicroCutter XPRESS 30, a true multi-fire laparoscopic stapling device designed to be used in a variety of procedures, including bariatric, colorectal, thoracic and general surgery. The Cardica MicroCutter products require 510(k) review and are not yet commercially available in the U.S. The Cardica MicroCutter XCHANGE 30 and XPRESS 30 are not currently commercially available.