REDWOOD CITY, Calif., April 28, 2014 /PRNewswire/ -- Cardica, Inc. (Nasdaq: CRDC) today announced that its MicroCutter® XCHANGE 30 surgical stapler was selected as a finalist in the surgical Equipment, Instruments and Supplies category of the Medical Design Excellence Awards (MDEA), one of the highest honors in the medical technology industry. The MicroCutter XCHANGE 30 is the world's smallest articulating surgical stapler, with a five millimeter shaft diameter and reloadable cartridges. Winners of the awards will be announced on June 11 in New York.
"The MicroCutter XCHANGE 30, with its small shaft diameter and increased articulation gives surgeons the ability to maneuver in small spaces, and represents the first significant reduction in stapler size and improved functionality in more than a decade," said Mike Chen, M.D., professor of surgery at University of Alabama School of Medicine and director, Division of Pediatric Surgery at UAB and Children's Hospital of Alabama. "As we pursue less invasive surgical options to reduce risk and recovery time for patients, I believe this device will be instrumental in our ability to perform even less invasive gastrointestinal procedures. It will be especially useful in infants and children."
The Medical Design Excellence Awards (MDEA) competition is the MedTech Industry's Premier Awards Program. Since its inception in 1998, the mission of the MDEA has been to recognize significant advances in medical product design and engineering that improve the quality of healthcare delivery and accessibility. Designed to focus attention upon the complexity of product development and to showcase examples of what can be achieved when it is well done, the MDEA celebrates the achievements of medical product manufacturers, their suppliers, and the many people behind the scenes—engineers, scientists, designers, and clinicians—who are responsible for the groundbreaking products that are saving lives, improving patient healthcare, and changing the face of MedTech.
"We are extremely honored to be named as a finalist for this prestigious award, as we believe it validates the design, innovation and unique features offered by the MicroCutter stapler," said Bernard A. Hausen, M.D., Ph.D., president and chief executive officer of Cardica. "We continue to innovate with the goal to provide surgeons with the tools they need to perform even less invasive procedures than they are today. We look forward to building on our portfolio of MicroCutter products to introduce a wide range of small, flexible staplers for a wide variety of surgical procedures."
The MicroCutter XCHANGE 30 is a cartridge-based, minimally-invasive stapling system with a 5-millimeter shaft diameter and cross sectional area significantly smaller than 12-millimeter conventional staplers, and with greater articulation. The size and degree of articulation enhances the surgeon's access and visualization at the surgical site. Combining several new technologies, this device is designed to mitigate limitations on surgical procedures created by larger stapling devices. As the smallest profile articulating stapler available today, the device may reduce the amount of tissue dissection and handling to get the stapler in proper position to fire. The XCHANGE 30 uses reloadable cartridges with a 30mm staple line length and an integrated knife.
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 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) review 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 49,000 units throughout the world.
The statements in this press release regarding the benefits expected for patients from Cardica's MicroCutter XCHANGE 30 and cartridges are "forward-looking statements." There are a number of important factors that could cause Cardica's results to differ materially from those indicated by this forward-looking statement, 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 in the United States may not perceive the benefits of the XCHANGE 30 to be sufficient to warrant its purchase; that prospective customers in the United States 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 December 31, 2013, under the caption "Risk Factors," filed on February 5, 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.
SOURCE Cardica, Inc.