Cardica Announces Positive Results of Long-Term Evaluation of Company’s C-Port® System for Vein Grafts in CABG Procedures
May 17 2016 - 12:00PM
Positive results of a clinical study of the C-Port® Distal
Anastomosis System from Cardica, Inc. (Nasdaq:CRDC) were presented
today at the Annual Meeting of the American Association for
Thoracic Surgery (AATS) by Husam Balkhy, M.D., associate professor
of Surgery and director of Robotic and Minimally Invasive Cardiac
Surgery at The University of Chicago’s Medicine & Biological
Sciences Division.
The MAGIC (Multicenter Assessment of Grafts in Coronaries)
Study, a long-term post-market evaluation of the C-Port device,
examined acute-to-mid-term and long-term vein graft occlusion rates
for coronary revascularization using the C-Port compared to
hand-sewn anastomoses. Patients receiving at least one C-Port
anastomosis during coronary artery bypass grafting (CABG) surgery
were enrolled at eight sites in the United States.
Results of the study indicated that the C-Port device is safe
and effective when used to create the distal anastomosis in CABG
surgery, with equivalent patency rates to hand-sewn grafts at 12
months. “When compared to hand-sewn anastomoses in a comparable
population in a recent large prospective trial, the C-Port device
demonstrated a statistically significant reduction in long-term
graft occlusion rates,” Dr. Balkhy said.
Dr. Balkhy has performed an extraordinary number of robotic
beating-heart, totally endoscopic coronary artery bypass, sometimes
known at TECAB, procedures completed with Cardica’s C-Port Flex-A®
– almost 500 since 2008. During these procedures, Dr. Balkhy has
completed over 800 endoscopic anastomoses on the beating heart with
the C-Port Flex-A device. “About 65 percent of my cases have
been multi-vessel procedures, and this would not be possible on the
beating heart if it were not for the Flex-A device,” he said.
“C-Port is a breakthrough approach to performing coronary bypass
surgery.”
Of the 117 patients enrolled in the MAGIC study (intent to treat
population: ITT), 78 patients with 104 C-Port vein grafts completed
the study to patency assessment via CT scanning (per protocol
population: PP). Clinical follow-up and index graft patency were
performed at least 12 months following surgery. The primary
efficacy endpoint was graft patency compared to a performance goal
established using the peer-reviewed results from the PREVENT IV
trial, which studied the efficacy and safety of the E2F
transcription factor decoy edifoligide. The primary safety endpoint
was MACE (death, myocardial infarction or target vessel
revascularization) rate at mid-term and long-term (12 months).
The ITT group had an overall mortality at 12 months of 0.8%
(1/117) and a MACE rate of 4.3% (5/117). Only two of these MACE
events occurred in patients who were included in the PP population,
and both patients had patent grafts. The C-Port vein graft
occlusion rate was 16.3% (PP population), compared to 26.6% in the
PREVENT IV trial. The C-Port arterial graft occlusion rate was
equivalent to the PREVENT IV trial. There were no significant
differences in the occlusion rate between the C-Port vein grafts,
16.3%, and the hand-sewn vein grafts, 14.9%, within the MAGIC
study.
“The results of The Magic Study confirm the innovative success
of C-Port, even in very small coronary arteries,” said Julian
Nikolchev, president and CEO of Cardica. “We applaud Dr. Balkhy’s
dedication to innovation for the benefit of his patients and are
thrilled that C-Port has played an important role in hundreds of
his totally endoscopic coronary artery bypass procedures.”
About the C-Port® Distal Anastomosis Systems (C-Port
systems)The C-Port systems – the C-Port xA system and the
Flex-A® system – can be used on- or off-pump and create compliant
anastomoses that expand and contract with blood flow. With
miniature stainless steel staples to secure the bypass graft to the
coronary artery, C-Port reduces time required for anastomosis,
which can be completed in two minutes. The C-Port systems work on
coronary arteries as small as 1.25 millimeters in internal diameter
and work with grafts of various diameters and wall thicknesses less
than 1.4 millimeters. The Flex-A system allows surgeons to position
the device to create a secure connection even in the most difficult
to reach areas of the heart.
About CardicaCardica designs and manufactures
proprietary stapling and automated 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 56,500 units throughout the world. In
addition, Cardica’s MicroCutter XCHANGE® 30, the world’s
smallest-profile articulating stapler, is manufactured and cleared
for use in the U.S. for transection and resection in multiple open
or minimally invasive urologic, thoracic and pediatric surgical
procedures, as well as application for transection, resection
and/or creation of anastomoses in the small and large intestine and
the transection of the appendix.
Forward-Looking StatementsThe statements in
this press release regarding Cardica’s beliefs as to the
confirmation of the innovative success of C-Port Flex-A in very
small coronary arteries are "forward-looking statements." There are
a number of important factors that could cause such results to
differ materially from those indicated by these forward-looking
statements, including: that the C-Port Flex-A may be unsuccessful
if used in very small coronary arteries as well as the 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 ended December 31, 2015, under
the caption “Risk Factors,” filed on February 10, 2016. 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.
Contact:
Investors:
Bob Newell
Vice President, Finance and Chief Financial Officer
(650) 331-7133
investors@cardica.com
Media:
Jessica Volchok
(310) 849-7985
jessica@nicoleosmer.com