Cardica Completes Enrollment In Long-Term Evaluation Study Of Its C-Port®
Distal Anastomosis Systems
REDWOOD CITY, Calif., Jan. 22, 2013
REDWOOD CITY, Calif., Jan. 22, 2013 /PRNewswire/ -- Cardica, Inc. (Nasdaq:
CRDC) today announced that the company has completed enrollment in the
Multicenter Assessment of Grafts in Coronaries (MAGIC) trial, its post market
surveillance study for the long-term evaluation of bypass grafts completed
using C-Port® Distal Anastomosis Systems. Cardica's C-Port systems are
automated stapling devices used to connect graft vessels during a heart bypass
"The long-term evaluation of the C-Port systems is expected to provide solid
data surrounding the use of this device to perform an automated anastomosis
during bypass procedures," said Dr. Husam H. Balkhy, associate professor of
Surgery Medical College of Wisconsin, director, Center for Robotic and
Minimally Invasive Cardiac Surgery at the Wisconsin Heart Hospital and
principal investigator of the trial. "Having used the C-Port systems regularly
over the last several years, I can confidently say that this device allows
surgeons to connect vessels in a reliable, repeatable way, and facilitates the
use of less invasive bypass procedures to minimize recovery time and improve
The study, which enrolled 115 patients at seven primary sites in the United
States, will evaluate the patency, or openness, of bypass graft vessels 12
months following a coronary artery bypass graft (CABG) procedure. The trial is
designed as a prospective, multi-center, open-label study. The graft occlusion
rates for commercialized C-Port devices are being compared to an a priori rate
taken from the published results of the PREVENT IV clinical trial, which
evaluated one year patency in more than 3000 patients following coronary
artery bypass graft procedures.
"We are pleased to complete enrollment in this confirmatory trial for our
C-Port systems, as we believe our automated cardiac devices facilitate less
invasive cardiac procedures, and with increased exposure to the product,
additional surgeons may adopt this unique product to benefit their patients,"
commented Bernard A. Hausen, president and CEO of Cardica.
Cardicadesigns 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 42,900 units throughout the world. In
addition,Cardicais developing the Cardica MicroCutter XCHANGE™ 30, a
cartridge-based microcutter device with a five-millimeter shaft diameter, and
the Cardica MicroCutter XPRESS™ 30, a true multi-fire laparoscopic stapling
device. Both MicroCutter devices are designed to be used in a variety of
procedures, including bariatric, colorectal, thoracic and general surgery. The
Cardica MicroCutter XCHANGE 30 and XPRESS 30 products require 510(k) review
and are not yet commercially available in the U.S.
The statements in this press release regarding Cardica's expectations with
respect to the data to be received from the evaluation of the C-Port systems,
Cardica's belief that its automated cardiac devices facilitate less invasive
cardiac procedures, and that additional surgeons may adopt this product, are
"forward-looking statements." The words "will," "believe," and "may" are
intended to identify these 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
may experience unexpected results in the evaluation of the C-Port systems
which could make the data not reliable for evaluating the C-Port systems and
could also cause additional surgeons not to adopt this product, and that
competing products may be developed that are equally or less invasive for
cardiac procedures than the C-Port systems which could also cause additional
surgeons not to adopt this product, and that the C-Port systems may face
development, regulatory, reimbursement and manufacturing risks; that Cardica's
intellectual property rights may not provide adequate protection of this
product;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 quarter endedSeptember 30, 2012.
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.
Contact: Bob Newell, Vice President, Finance and Chief Financial Officer,
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