Cardica, Inc. (Nasdaq: CRDC) today announced that an initial Microcutter™ 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™, 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™ 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™ 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.
Source : Cardica, Inc.