DiagnosticsCardica Announces Publication Of Pivotal PAS-Port(R) Proximal Anastomosis System Clinical Trial Results
Cardica, Inc. (Nasdaq: CRDC) announced that the full results of the PAS-Port system multi-center pivotal trial, known as the EPIC trial, were published in the July issue of the peer-reviewed publication The Journal of Thoracic and Cardiovascular Surgery. The PAS-Port system, which received 510(k) clearance from the U.S. Food and Drug Administration (FDA) in September 2008, 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.
"The data published this month confirm that the PAS-Port system produces comparable patency, saves approximately five minutes per connection and eliminates the need to clamp the aorta required for hand-sewn connections," commented John D. Puskas, M.D., chief of cardiac surgery at Emory Crawford Long Hospital in Atlanta and principal investigator of the EPIC trial. "Overall, Cardica"s PAS-Port system provides a safe and reliable alternative to hand-sewing vessels during CABG procedures."
Cardica conducted the 220-patient pivotal, prospective, randomized trial at 12 sites in the United States and Europe. In the trial, two venous bypass grafts were randomly selected in each patient to be connected to the aorta. The PAS-Port system was used for one graft and the conventional hand-sewn technique for the other, for a total of 440 randomized grafts. Patients were scheduled to receive a follow-up angiogram nine months after their index procedure to determine patency (or degree of openness of the vein graft) for both the PAS-Port and control grafts. Over 90 percent of the patients received these angiograms.
The data published show that the PAS-Port system met the primary efficacy endpoint of non-inferiority in patency at nine-month follow up compared to hand-sewn anastomoses. In addition, of the 12 major adverse cardiac events (MACEs) reported that may possibly be related to target vessel revascularization, four (33%) may have been related to the PAS-Port system with eight (67%) potentially related to hand-sewn anastomoses. During the trial, four patients had a stroke. In all cases of stroke, an aortic clamp was used for construction of a hand-sewn anastomosis. The study also demonstrated that the PAS-Port system saves approximately five minutes of operating room time when compared to both side-biting and facilitating hand-sewn anastomoses.
"Used in the United States, Japan and Europe during thousands of CABG procedures to date, the PAS-Port system allows surgeons to perform rapid, safe and effective automated anastomoses either on- or off-pump, with very little manipulation of the aorta," said Bernard A. Hausen, M.D., Ph.D., president and chief executive officer of Cardica, Inc. "Importantly, during the trial there were four cases of stroke, all of which occurred in patients where the aorta was clamped for hand-sewn anastomoses. By eliminating the need to clamp the aorta, we believe the PAS-Port system offers a significant benefit to bypass patients with no increased risk."
The PAS-Port Proximal Anastomosis System Advantage
The innovative design of the PAS-Port system allows a surgeon to load the bypass graft into the system and rapidly complete the anastomosis, typically in approximately two minutes, with little or no injury to the bypass graft vessel or the aorta. As of March 31, 2009, almost 14,000 PAS-Port systems had been sold in the United States, Japan and Europe, and according to Cardica"s distributor, today this product is used in more than 20 percent of all proximal anastomoses performed using a vein bypass graft during CABG surgeries in Japan.
About Cardica
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-Port(R) Distal Anastomosis Systems are marketed in the United States and Europe and its PAS-Port(R) Proximal Anastomosis System is marketed in the United States, Europe and Japan.
Forward-Looking Statements
This press release contains "forward-looking statements," including, without limitation, statements related to Cardica"s therapeutic and commercial potential for its PAS-Port Proximal Anastomosis System. The words "may," "believe" 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, without limitation, that Cardica"s current and any future products may never gain any significant degree of market acceptance, that any future Cardica products face regulatory, reimbursement and manufacturing risks, that Cardica"s intellectual property rights may not provide adequate protection and that Cardica will need substantial additional funding and may be unable to raise capital when needed, which would force Cardica to delay, reduce or eliminate its research and development programs or commercialization efforts, as well as other risks detailed from time to time in Cardica"s reports filed with the SEC, including its Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2009. Cardica expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in the company"s expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.
Cardica, Inc.