Cardica's C-Port(R) Flex A(R) Anastomosis System Facilitates Groundbreaking Port Only Robotic Beating Heart Bypass Surgery
REDWOOD CITY, Calif., May 5 /PRNewswire-FirstCall/ -- Cardica, Inc.
(Nasdaq: CRDC) today announced that Husam H. Balkhy, M.D., chairman of the
department of cardiothoracic surgery at The Wisconsin Heart Hospital in
Milwaukee Wis., is one of the first cardiovascular surgeons in the United
States to have performed several revolutionary closed-chest coronary artery
bypass graft (CABG) procedures on a beating heart with the aid of the
da Vinci(R) Surgical System. Applying his extensive experience with the
C-Port(R) Flex A(R) Anastomosis System to robotic chest surgery, Dr. Balkhy
has completed eight closed-chest beating heart CABG procedures on patients,
all of whom were discharged an average of two days following surgery and were
able to return to normal daily activities within two weeks.
During the procedure, Dr. Balkhy guides the da Vinci Surgical System to
perform precise movements through fingertip-size incisions in the chest area,
using a high definition camera and scope to facilitate visualization inside
the chest. The off-pump, or "beating heart," bypass surgery is performed
robotically without cutting the sternum and without the use of a traditional
heart-lung machine.
"With the availability of the C-Port Flex A system and the recent
introduction in the United States of Intuitive Surgical's EndoWrist(R)
Stabilizer, we are seeing a convergence of technology that I expect will
change the future of coronary bypass procedures and provide significant
benefit to patients," said Dr. Balkhy.
"Multiple studies have shown that beating heart coronary bypass surgery
has several benefits over traditional arrested heart coronary bypass surgery,
in which the heart-lung machine is used. We have incorporated the beating
heart approach in our practice for many years. I believe the newfound ability
to 'spare the sternum' and perform bypass surgery using an all-port approach
on the beating heart, with innovations such as the C-Port Flex A system and
the da Vinci Surgical System, will further shorten recovery times and improve
patient outcomes. As more surgeons become proficient performing this surgery,
I believe that coronary bypass surgery may ultimately become a procedure
requiring a relatively short hospital stay, a quicker return to activity and
excellent outcomes for the majority of patients."
The C-Port Flex A system automates the attachment of the bypass graft to
the coronary artery, eliminating the need to sew the graft using traditional
suture and thread. "Just as a sewing machine can improve the reproducibility
and speed of clothing production, I believe that this automated stapling
device offers similar benefits by improving the reproducibility and speed of
attaching the graft vessel during CABG surgery," added Dr. Balkhy, who has
used the C-Port Flex A system more often than any other cardiovascular surgeon
in the United States.
"These landmark procedures represent a significant advance for the field
of cardiothoracic surgery. While the theory of beating heart robotic cardiac
bypass surgery has been around for many years, the availability of the C-Port
Flex A system is helping to enable robotic surgery on a beating heart to
become a reality in cardiac surgery," said Bernard A. Hausen, M.D., Ph.D.,
president and chief executive officer of Cardica. "The C-Port Flex A device
improves quality, reliability and consistency of bypass graft connections and
can connect grafts at the back of the heart where it would be difficult or
impossible to hand sew."
New Alternatives to Traditional Coronary Artery Bypass Surgery
In the majority of CABG procedures in the United States, the patient's
sternum is split so the chest can be opened, and the heart is stopped
temporarily while surgeons hand sew vessels together to bypass the blockages
while a mechanical pump keeps the blood circulating through the body.
Patients who receive on-pump CABG procedures stay in the hospital an average
of five to seven days, and it can take up to two to three months for the
patient to return to normal activity.
During a traditional "beating heart" bypass procedure, the patient's
sternum is split, but the patient's heart continues to beat while a surgeon
stabilizes the area of the heart to be bypassed. Eliminating the use of the
heart-lung machine has been shown to reduce complications such as stroke,
increased need for blood transfusions, and kidney and lung complications.
By using the robot together with the C-Port Flex A system, the beating
heart procedure can be performed on a closed chest. Patients undergoing
closed-chest CABG procedures may be discharged in 24 to 48 hours following
surgery, and often return to normal activity levels within one to two weeks.
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 Europe and the United States. The PAS-Port(R) Proximal Anastomosis System
is marketed in Europe and Japan, and Cardica has submitted a 510(k) premarket
notification for clearance to market the PAS-Port system in the United States.
Cardica also is developing additional devices with Cook Medical to facilitate
vascular closure and other surgical procedures.
Forward-Looking Statements
This press release contains forward-looking statements, including, without
limitation, statements related to the potential improved patient outcomes and
expanded accessibility of closed-chest CABG procedures from future use of
C-Port Flex-A systems and the potential of C-Port Flex-A systems in the field
of cardiothoracic surgery. The words "believe," "may," "will," "expect" and
similar expressions are intended to identify forward-looking statements.
These forward-looking statements are based upon Cardica's current
expectations. Forward-looking statements involve risks and uncertainties.
Cardica's actual results and the timing of events could differ materially from
those anticipated in such forward-looking statements as a result of these
risks and uncertainties, which include, without limitation, risks associated
with the long-term patency of graft vessels connected using the C-Port Flex-A
system, market acceptance of Cardica's C-Port Flex-A system, manufacturing of
the C-Port Flex-A system and its suppliers, and Cardica's sales, marketing and
distribution strategy and capabilities. These and other risk factors are
discussed under "Risk Factors" in Cardica's Quarterly Report on Form 10-Q for
the fiscal quarter ended December 31, 2007. 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 the
Company's reports filed with the U.S. Securities and Exchange Commission,
available at http://www.sec.gov.
SOURCE Cardica, Inc.