Cardica Receives European CE Mark for Initial Microcutter(TM) Surgical Cutting and Stapling Device
REDWOOD CITY, Calif., March 4, 2011 /PRNewswire/ — Cardica, Inc. (Nasdaq: CRDC) today announced that an initial Microcutter(TM) surgical cutting and stapling device developed by Cardica has received CE Mark certification. As an integral part of the multi-step CE marking process, Cardica has obtained a Full Quality Assurance certification for its Microcutter design and manufacturing processes. With this certification, after successful completion of development, Cardica can apply the CE Mark to the first Microcutter product that Cardica expects to commercialize, the Microcutter XPRESS 30(TM), and will be able to apply the CE Mark to future devices within the Microcutter product line that comply with the certified design and manufacturing processes in the same manner.
“Receiving the CE Mark for an initial Microcutter device is a significant milestone in our progress towards the commercialization of Cardica’s innovative and proprietary staple-on-a-strip technology,” said Bernard A. Hausen, M.D., Ph.D., president and chief executive officer of Cardica. “Moving forward, we expect to successfully complete development of the Microcutter XPRESS 30(TM) and begin using it in selected European surgical centers to gain initial experience with the product. Integrating feedback from our initial experience in Europe, we intend to conduct a limited market release of our XPRESS 30(TM) product to approximately 20 to 30 leading surgeons in the United States in mid-2011, subject to U.S. Food and Drug Administration clearance under a 510(k) process.”
CE marking indicates that Cardica’s design and manufacturing processes for the initial Microcutter device comply with certain manufacturing and design standards under the European Directive concerning medical devices. As an integral step in obtaining the CE Mark for an initial Microcutter device, Cardica successfully extended the scope of its existing ISO 13485:2003 and Medical Device Directive certifications, confirming the company’s compliance with globally recognized quality management and quality assurance systems.
About Cardica’s Microcutter Product Line
Cardica’s Microcutter surgical cutting and stapling product line is designed to provide true multi-fire endoscopic stapling in a variety of procedures, including colorectal, thoracic and general surgery. The Microcutter line is designed to cut and staple continuously, allowing a surgeon to complete successive deployments without removing the device for a cartridge reload. The first device in the Microcutter product line that Cardica expects to commercialize, the Microcutter XPRESS 30(TM), is 8 mm in diameter, compared to commercialized stapling products that are at least 12 mm in diameter. The smaller diameter of the anticipated Microcutter line allows access through smaller, less-invasive ports and, importantly, through trocars used for the other surgical tools required for laparoscopic procedures. All of Cardica’s anticipated Microcutter devices are designed to articulate to a greater degree than currently commercially available staplers. Additional planned iterations of the Microcutter product line include the Microcutter XCHANGE 30(TM), with a shaft diameter of 5 mm, and the Microcutter FLEXCHANGE 30(TM), with a flexible shaft, and are designed to enable port-access surgeries, including robot-assisted surgery, Natural Orifice Transluminal Endoscopic Surgery (NOTES) and Single-Incision Laparoscopic Surgery (SILS) interventions, all emerging surgical fields. All of Cardica’s Microcutter products under development require regulatory clearance through the 510(k) or other process with the U.S. Food & Drug Administration and are not yet commercially available in the U.S.
Cardica designs and manufactures proprietary stapling and anastomotic devices for cardiac and endoscopic 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-PortÃ‚® Distal Anastomosis Systems and PAS-PortÃ‚® Proximal Anastomosis System, for coronary artery bypass graft (CABG) surgery and has shipped over 33,000 units throughout the world. In addition, Cardica is developing the Cardica Microcutter XPRESS 30(TM), a true multi-fire endoscopic stapling device designed to be used in a variety of procedures, including bariatric, thoracic and general surgery. The Cardica Microcutter XPRESS 30(TM) requires regulatory clearance through the 510(k) or other process with the U.S. Food & Drug Administration and is not yet commercially available in the U.S.
This press release contains “forward-looking” statements, including all statements regarding the future development, potential surgical uses, regulatory approval and commercialization of products in Cardica’s proposed Microcutter product line, including the Cardica Microcutter XPRESS 30(TM), and the timing thereof. Any statements contained in this press release that are not historical facts may be deemed to be forward-looking statements. The words “can,” “expect,” “intend,” “will,” “anticipated,” “planned” and similar expressions are intended to identify 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 the Microcutter device as to which Cardica has received CE Mark certification is not a device that Cardica expects to commercialize; Cardica may not be successful in its efforts to develop the Cardica Microcutter XPRESS 30(TM) or any other microcutter products and to expand its product portfolio; that the Microcutter XPRESS 30(TM) may not be subject to a 510(k) rather than longer Premarket Approval application process or otherwise may not obtain U.S. regulatory approval on Cardica’s anticipated timeline, if at all; that Cardica’s current and any future products may never gain any significant degree of market acceptance; that any future Cardica products face development, regulatory, reimbursement and manufacturing risks; that Cardica’s intellectual property rights may not provide adequate protection; that Cardica’s sales, marketing and distribution strategy and capabilities may not be sufficient or successful; and that general business and economic conditions may impair Cardica’s ability to market and develop products, 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 fiscal quarter ended December 31, 2010. 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.