Healthcare Industry News: C-Port
News Release - January 9, 2014
Cardica Receives 510(k) Clearance For MicroCutter XCHANGE(TM) 30 Cutting/Stapling DeviceREDWOOD CITY, Calif., Jan. 9, 2014 -- (Healthcare Sales & Marketing Network) -- Cardica, Inc. (CRDC) today announced it obtained 510(k) clearance of the MicroCutter XCHANGE™ 30 device and blue staple cartridge for medium thickness tissue from the U.S. Food and Drug Administration for use in multiple open or minimally-invasive surgical procedures for the transection, resection and/or creation of anastomoses in small and large intestine, as well as the transection of the appendix. The XCHANGE 30 is the smallest diameter cutting and stapling device available today, with articulation up to 80 degrees and single-handed operation.
"We are extremely pleased to achieve this important corporate milestone, allowing us to market the MicroCutter XCHANGE 30 in the United States," said Bernard A. Hausen, M.D., Ph.D., president and CEO of Cardica. "We have been working with leading European surgeons in a commercial setting over the past year to optimize this device for use in both open and laparoscopic procedures. We look forward to implementing a selective commercial launch in the United States in the months ahead to address the growing need for a smaller surgical stapling device. Looking beyond the initial introduction, we plan to submit our 510(k) premarket notification for the white stapling cartridge for thin tissue and blood vessels also used with the XCHANGE 30 device, in the current quarter, to further expand the device's applicability in surgical procedures."
The clearance of the XCHANGE 30 and the blue stapling cartridge for medium thickness tissue is based on data submitted from Cardica's European clinical trial to evaluate the XCHANGE 30 in a variety of gastrointestinal surgical procedures. The XCHANGE 30, with a 5-millimeter shaft diameter, met the primary endpoint of non-inferiority to a 12-millimeter stapler, with only one device-related event in 160 enrolled patients with 423 deployments.
"Over the course of the last decade, surgical tool size has trended down substantially to allow for less invasive surgical procedures with better patient outcomes," said Juan-Carlos Verdeja, M.D., F.A.C.S., associate professor of surgery and director of laparoscopy and minimally invasive surgery at Florida International University Herbert Wertheim College of Medicine. "The MicroCutter XCHANGE 30 meets the need for increasingly smaller surgical tools, and provides a significant and needed innovation. This device can now be used with a smaller trocar, particularly important during surgical procedures where multiple angles are helpful for an approach to an organ."
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 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 and is currently indicated to fire up to six times per device.
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 manufactures and markets its MicroCutter XCHANGE™ 30, a cartridge-based surgical stapling device with a five-millimeter shaft diameter, for use in a variety of gastrointestinal procedures and appendectomies in the United States and 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 47,700 units throughout the world.
The statements in this press release regarding Cardica's intent to implement a selective commercial launch of the XCHANGE 30 in the United States in the months ahead and to submit a 510(k) clearance application for its white stapling cartridge in the current quarter 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 the XCHANGE 30 may face unanticipated development, regulatory, or manufacturing delays; that the timing of 510(k) applications and receipt of clearance for such applications may be delayed by unanticipated events, 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 September 30, 2013, under the caption "Risk Factors." 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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