Healthcare Industry News: anastomosis system
News Release - June 8, 2006
Cardica's Automated Anastomosis Systems Featured at Major Cardiac Surgery ConferenceCases and Data Presented Today at the International Society for Minimally Invasive Cardiothoracic Surgery (ISMICS) Annual Meeting
SAN FRANCISCO, June 8 (HSMN NewsFeed) -- Cardica, Inc. (Nasdaq: CRDC ) today announced that leading cardiothoracic surgeons are presenting oral and video cases and data demonstrating the safety and efficacy achieved with the Company's automated C-PortŪ and PAS-PortŪ anastomosis systems, which facilitate coronary artery bypass graft (CABG) procedures. Surgeons are reviewing experiences and data using these novel systems at their respective institutions at the International Society for Minimally Invasive Cardiothoracic Surgery (ISMICS) annual meeting being held here from June 7-9.
"The C-Port Distal anastomosis system offers unique advantages over traditional hand-sewn sutures, including automated reliability, ease of use and consistent performance," said Husam H. Balkhy, M.D., Chairman, Department of Cardiothoracic Surgery at the Wisconsin Heart Hospital and Clinical Assistant Professor at the Medical College of Wisconsin in Milwaukee, who presents a video case study using the system today. "Use of the C-Port system enables improved patient care by providing more compliant anastomoses than could be achieved by standard hand-sewn suture techniques. We have observed excellent flow and pulsatility indexes, two of the early predictors of graft patency, in more than 80 beating and non-beating heart surgeries. Our early experience with this new device would indicate that the patency rates of the resulting compliant anastomosis should prove to be better than traditional hand-sewn suture techniques (as shown in previous European trials), and that it has great potential in facilitating future closed chest coronary bypass."
The C-Port Distal anastomosis system, which can be used in either on or off-pump CABG procedures, is a fully-automated device designed to perform an end-to-side distal anastomosis by attaching the end of a bypass vein graft to a coronary artery downstream of an occlusion or narrowing. The device is approved for use in the United States and Europe.
In a separate presentation at ISMICS, Drs. Tomita, Watanabe, Iino, Higashidani and Ujiie will present positive data on Cardica's PAS-Port Proximal anastomosis system in an oral presentation titled "Angiographic Evaluation of PAS-Port Proximal Vein Graft Anastomoses System." In this presentation, Dr. Tomita will present graft patency data from more than 150 PAS-Port anastomoses showing a patency rate of 96.6% at patient discharge. These results compare favorably to historical control data from the medical literature.
The PAS-Port system is a fully-automated device used to perform an end-to-side proximal anastomosis between a saphenous vein and the aorta, the most common element of a CABG surgery. The PAS-Port system is approved for sale in Europe and Japan. Cardica expects to begin a prospective, randomized, multi-center clinical trial with the PAS-Port system to support an application for U.S. regulatory approval of this device.
"These presentations help validate the utility and reliability of our systems to an international audience of cardiac surgeons," said Bernard A. Hausen, M.D., Ph.D., President and Chief Executive Officer of Cardica. "By enabling consistent and reliable anastomoses of the vessels, we believe that our automated systems can improve patient results while reducing time and cost. In bowel surgery, automated anastomosis systems have already become standard of care, and we are seeking to duplicate this for vascular surgery."
About CABG Surgery
Coronary heart disease causes one out of every five deaths in the United States, making it the single largest killer of Americans. While other treatment alternatives exist, studies show that CABG surgery achieves the best long-term patient outcome for coronary heart disease as measured by survival rate and need for re-intervention. In 2006, an estimated 250,000 CABG procedures will be performed in the United States, each requiring approximately five anastomoses, often considered the most critical step of the surgery. The current method of performing an anastomosis in a CABG procedure utilizes technically demanding, tedious and time-consuming hand sewn sutures to connect a bypass graft vessel to the aorta and to small diameter coronary vessels.
About Cardica, Inc.
Cardica designs and manufactures automated anastomosis systems for coronary artery bypass graft (CABG) surgery. By replacing hand-sewn sutures with easy-to-use automated systems, Cardica provides cardiovascular surgeons with rapid, reliable and consistently reproducible anastomoses, or connections of blood vessels, the most critical aspect of the CABG procedure.
The C-PortŪ Distal anastomosis system is marketed in Europe and the United States. The PAS-PortŪ Proximal anastomosis system is marketed in Europe and Japan. Cardica also is developing additional devices to facilitate vascular and other surgical procedures. Go to www.cardica.com for more information.
Forward Looking Statements
This press release contains "forward-looking" statements, including statements relating to planned clinical trials, the efficacy, clinical acceptance and future use of Cardica's C-Port Distal anastomosis system and PAS-Port Proximal anastomosis system and other matters. Any statements contained in this press release that are not historical facts may be deemed to be forward-looking statements. The words "believe," "plan," "expect," "estimate," "intend" and "will" or 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 risks associated with the clinical performance and market acceptance of Cardica's anastomosis system and the timing and success of the planned multi-national clinical trial using Cardica's PAS-Port system, as well as other risks detailed from time to time in Cardica's SEC reports, including its Quarterly Report on Form 10-Q for the quarter ended March 31, 2006. Cardica does not undertake any obligation to update forward-looking statements. You are encouraged to read the Company's reports filed with the U.S. Securities and Exchange Commission, available at www.sec.gov.
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