Healthcare Industry News: Cook
News Release - September 9, 2008
Cardica Receives 510(k) Clearance to Market PAS-Port(R) Proximal Anastomosis System for Use in Cardiac Bypass SurgeryConference Call/Webcast Today at 11:00 a.m. Eastern Time
REDWOOD CITY, Calif., Sept. 9 (HSMN NewsFeed) -- Cardica, Inc. (Nasdaq: CRDC ) today announced that the U.S. Food and Drug Administration (FDA) has granted the company 510(k) clearance to market its PAS-PortŪ Proximal Anastomosis System for use in cardiac bypass surgery. 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 coronary artery bypass grafting (CABG) procedures. Currently available in Japan and Europe, where it has been used more than 8,800 times, the PAS-Port system is now commercially available by Cardica in the United States.
The current method of connecting a bypass graft vessel to the aorta (known as 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. The PAS-Port system allows a surgeon to complete an automated proximal anastomosis without the need to clamp and manipulate the aorta. Eliminating the clamp may greatly reduce the risk of particle release and ensuing neurocognitive events.
The PAS-Port system offers surgeons, hospitals, payors and patients several other advantages over traditional, technically demanding and often tedious to perform hand-sewn anastomoses:
-- An integrated tool that is fully automated. The PAS-Port system's innovative design allows surgeons to load the bypass graft into the system and rapidly complete the anastomosis, typically in approximately one minute. This reduces the time required for the anastomosis while providing a consistent, reliable connection.(1)
-- The bypass graft is loaded into the system without damaging endothelial cells while maximizing the orifice, which is especially important with a small graft.
-- No metal is within the lumen of the graft vessel.
-- According to results from the pivotal clinical trial of the PAS-Port system, anastomosis surgical time is significantly reduced compared with hand-sewn anastomoses.
-- Patient outcomes may be improved due to shortening of surgery times and hospital stays and reducing complications associated with aortic clamping.
"The PAS-Port system is associated with significant patient benefits compared with hand-sewn anastomoses," said John Puskas, M.D., chief of cardiothoracic surgery at Emory Crawford Long Hospital, associate chief of cardiothoracic surgery at Emory University, and principal investigator of the PAS-Port pivotal clinical trial. "Because the PAS-Port device can be used to create a proximal anastomosis without needing to clamp the aorta, it may ultimately improve patient outcomes by shortening surgery times and hospital stays and reducing complications associated with aortic clamping."
Cardica conducted a 220-patient, prospective, pivotal, randomized trial of PAS-Port at 12 sites in the United States and Europe. The trial compared venous bypass graft vessel connections to the aorta made using the PAS-Port system versus those made using conventional hand-sewn sutures. Results showed that the study met its primary endpoint of non-inferiority to hand-sewn anastomoses, as well as all other primary and secondary endpoints.
"With the introduction of the PAS-Port system in the United States, cardiothoracic surgeons are now provided with a complete package of reliable, automated revascularization systems for use in CABG procedures," said Bernard A. Hausen, M.D., Ph.D., president and chief executive officer of Cardica. "We believe that by replacing hand-sewn sutures, our automated proximal and distal anastomoses systems can help cardiovascular surgeons perform consistent, reliable anastomoses with even the smallest of vessels, giving surgeons greater ability to use minimally invasive techniques for cardiac surgery. We plan on launching PAS-Port in the U.S. in the next several weeks with a systematic and deliberate roll-out to surgeons and look forward to training 50 to 60 surgeons per quarter, as we previously have discussed."
As of June 30, 2008, more than 8,800 PAS-Port systems had been sold worldwide, with the vast majority of units deployed in Japan. According to Cardica's Japanese distributor, the PAS-Port system is used today in more than 20 percent of all proximal anastomoses performed using a vein bypass graft during CABG surgeries in Japan.
Cardica has launched a new website that will provide detailed information about the PAS-Port system, including animation video, clinical articles, a product brochure, product images and information about training sessions. The website can be accessed at http://www.goclampless.com.
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. The National Center for Health Statistics estimates that in 2005 approximately 260,000 patients had CABG surgeries in the United States. Each CABG procedure requires approximately five anastomoses, often considered the most critical step of the surgery.
Conference Call Details
To access the live conference call via phone, please dial 866-713-8395 in the United States and Canada or +1-617-597-5309 internationally. The conference ID is 57153283. Please dial in approximately 10 minutes prior to the start of the call. A telephone replay will be available beginning approximately one hour after the call through September 16, 2008, and may be accessed by dialing 888-286-8010 from the United States and Canada or +1-617-801-6888 internationally. The replay passcode is 32640672. To access the live and subsequently archived webcast of the conference call, go to the Investor Relations section of Cardica's website at http://www.cardica.com. Please connect to the website at least 15 minutes prior to the call to allow for any necessary software downloads.
The webcast is also being distributed through the Thomson StreetEvents Network. Individual investors can listen to the call at http://www.earnings.com, Thomson's individual investor portal, powered by StreetEvents. Institutional investors can access the call via Thomson StreetEvents (http://www.streetevents.com), a password-protected event management site.
Cardica is a leading provider of automated anastomosis systems for coronary artery bypass graft (CABG) surgery. By replacing hand-sewn sutures with easy-to-use automated systems, Cardica's products provide cardiovascular surgeons with rapid, reliable and consistently reproducible anastomoses, or connections of blood vessels, often considered the most critical aspect of the CABG procedure. Cardica's C-PortŪ Distal Anastomosis Systems are marketed in Europe and the United States. The PAS-PortŪ Proximal Anastomosis System is marketed in Europe, Japan and the United States. Cardica also is developing additional devices with Cook Medical to facilitate vascular closure and other surgical procedures.
This press release contains "forward-looking" statements, including statements relating to the commercial availability and adoption of Cardica's PAS-Port system in the United States. Any statements contained in this press release that are not historical facts may be deemed to be forward-looking statements. The words ""will" and "believe" 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 obtaining third party coverage and reimbursement for the PAS-Port system, the lack of long-term data regarding the safety and efficacy of Cardica's products, the need for Cardica's products to gain market acceptance and Cardica's limited experience as a company in the sales, marketing and distribution of its products, 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 fiscal quarter ended March 31, 2008. Cardica does not undertake any obligation to update forward-looking statements. You are encouraged to read the Cardica's reports filed with the U.S. Securities and Exchange Commission, available at http://www.sec.gov.
(1) Data on file at Cardica, Inc.
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