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SOURCE Cardica, Inc.
-- Smaller-Sized Stapler Gives Pediatric Surgeons the Size They Have Been Waiting for --
REDWOOD CITY, Calif., June 18, 2014 /PRNewswire/ -- Cardica, Inc. (Nasdaq: CRDC) today announced that its MicroCutter XCHANGE® 30, the world's first and only five-millimeter surgical stapler that articulates to 80 degrees, was featured as part of the Endosurgical Simulation Course at the 45th Annual Meeting of the American Pediatric Surgical Association (APSA) in Phoenix, Arizona.
"I am very pleased that a new surgical stapler has been developed that provides pediatric surgeons with another option for our patients, and we no longer need to adapt the larger surgical staplers designed for adult patients for pediatric procedures," said Carroll M. Harmon, M.D., Ph.D., chief of the Division of Pediatric Surgery at the University of Buffalo School of Medicine and Biomedical Sciences and pediatric surgeon-in-chief at Women & Children's Hospital of Buffalo "I believe this device will enable the conversion of open gastrointestinal procedures to minimally invasive approaches, as less invasive procedures have been clinically proven to reduce pain and complications, such as infection. I believe that this device will accelerate the advancement of pediatric minimally invasive techniques for this special patient population."
Cardica was invited to participate in the APSA conference and support the Endosurgical Simulation Course to make pediatric surgeons aware of the latest techniques in minimally-invasive surgery. Led by program directors, Katherine A. Barsness, M.D., M.S., director of surgical simulation and surgical outcomes research, and attending physician at the Ann & Robert H. Lurie Children's Hospital of Chicago, and Carroll McWilliams "Mac" Harmon, M.D., Ph.D., chief of the division of pediatric surgery and director of the pediatric surgery fellowship at the University of Buffalo School of Medicine and Biomedical Sciences and pediatric surgeon-in-chief at Women & Children's Hospital of Buffalo, this hands-on training course enabled pediatric surgeons from around the U.S. to develop skills under the guidance of the leading minimally invasive pediatric surgeons in the world. Attendees performed simulated minimally-invasive procedures to hone their skills in this lab.
"The MicroCutter XCHANGE 30 is the smallest articulating surgical stapler available in the United States today," commented Bernard A. Hausen, M.D., Ph.D., president and CEO of Cardica. "We appreciate the opportunity to engage with and support the development of a large group of pediatric surgeons, who clearly appreciate the fact that the MicroCutter has a cross sectional area six times smaller than conventional staplers. We believe that the XCHANGE 30 fits directly with the organization's mission to ensure optimal pediatric surgical care of patients and their families, to promote excellence in the field."
Cardica designs and manufactures proprietary stapling and anastomotic devices for cardiac and laparoscopic surgical procedures. Cardica's technology portfolio is intended to reduce operating time and facilitate minimally-invasive and robot-assisted surgeries. Cardica's MicroCutter XCHANGE® 30, a cartridge-based articulating surgical stapling device with a five-millimeter shaft diameter, is manufactured and cleared for use in a variety of gastrointestinal procedures and appendectomies in the United States, and is marketed for a wide range of surgical procedures in Europe. Cardica is developing the Cardica® MicroCutter XCHANGE® 45, a cartridge-based microcutter device that is being designed with an eight-millimeter shaft to be used in a variety of procedures, including bariatric, colorectal, thoracic and general surgery. The Cardica MicroCutter XCHANGE 45 product requires 510(k) clearance and CE Mark and is not yet commercially available in the U.S. or internationally. In addition, 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 50,000 units throughout the world.
The statements in this press release regarding the belief that the XCHANGE 30 will enable the conversion of open gastrointestinal procedures to minimally invasive approaches, and that the XCHANGE 30 will accelerate the advancement of minimally invasive techniques for the pediatric patient population, are "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 not be successful in its efforts to commercialize the XCHANGE 30 due to unanticipated technical or other difficulties; that prospective customers may not perceive the benefits of the XCHANGE 30 to be sufficient to warrant its purchase; that prospective customers may be constrained by pricing pressures or purchasing requirements in the hospitals and facilities in which they work, which could prevent them from purchasing the XCHANGE 30; 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 ended March 31, 2014, under the caption "Risk Factors," filed on May 7, 2014. 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.
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