Navigation Links
Cardica Receives European CE Mark for Initial Microcutter™ Surgical Cutting and Stapling Device
Date:3/4/2011

REDWOOD CITY, Calif., March 4, 2011 /PRNewswire/ -- 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.

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™, 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™, with a shaft diameter of 5 mm, and the Microcutter FLEXCHANGE 30™, 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.

About Cardica

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-Port® Distal Anastomosis Systems and PAS-Port® 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™, 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™ 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.

Forward-Looking Statements

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™, 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™ or any other microcutter products and to expand its product portfolio; that the Microcutter XPRESS 30™ 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.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Cardica Announces Fiscal 2011 Second Quarter Financial Results
2. Cardica Announces $10 Million At-The-Market Common Stock Financing Agreement
3. Cardica Announces Fiscal 2011 First Quarter Financial Results
4. Cardicas Automated Anastomosis Systems Featured at Advances In Robotic And Hybrid Coronary Revascularization Meeting
5. Cardica Announces Fiscal 2010 Fourth Quarter and Year End Financial Results
6. Cardica and Intuitive Surgical Enter Into License Agreement
7. Cardica to Announce Fiscal 2010 Fourth Quarter and Year End Financial Results on Tuesday, August 17, 2010
8. Cardica to Present at 9th Annual Needham Healthcare Conference on Wednesday, June 9, 2010
9. Cardica to Announce Fiscal 2010 Third Quarter Financial Results on Tuesday, May 4, 2010
10. Cardica Announces Fiscal 2010 Second Quarter Financial Results
11. Cardica Announces Fiscal 2010 First Quarter Financial Results and Business Progress
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/10/2017)... --  West Pharmaceutical Services, Inc. (NYSE: WST), a ... today shared the results of a study highlighting the ... administration of polio vaccines. The study results were presented ... by Dr. Ondrej Mach , Clinical Trials and ... and recently published in the journal Vaccine. i ...
(Date:10/5/2017)... 5, 2017  In response to the nationwide ... Maxillofacial Surgeons (AAOMS) released prescribing recommendations that urge ... used as a first-line therapy to manage a ... Recognizing the value and importance ... "Opioid Prescribing: Acute and Postoperative Pain Management" stresses ...
(Date:10/4/2017)... Oct. 4, 2017  According to the Centers for Disease Control and ... October . PhysicianOne Urgent Care is helping communities across Massachusetts ... , by offering no-cost* flu shots through the end of the ... certain health insurance regulations. ... time to get a flu shot is by the end of October, ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... ... Yisrayl Hawkins, Pastor and Overseer at The House of Yahweh, has released ... understood books in the Holy Scriptures, Revelation. The Book of Revelation paints a picture ... Many have tossed it off as mere rubbish, but Yisrayl Hawkins says that is ...
(Date:10/13/2017)... ... October 13, 2017 , ... “America On The Brink”: the Christian history of ... Brink” is the creation of published author, William Nowers. Captain Nowers and his ... veteran, he spent thirty years in the Navy. Following his career as a ...
(Date:10/12/2017)... WAUSAU, Wis. (PRWEB) , ... October 12, 2017 ... ... formulated standard products to meet the demand of today’s consumer and regulatory authorities ... team of probiotic experts and tested to meet the highest standard. , ...
(Date:10/12/2017)... ... October 12, 2017 , ... ... system that we intend to develop to enable prevention of a major side ... severe hearing loss, especially in pediatric patients. For cisplatin, hearing loss is FDA ...
(Date:10/12/2017)... ... October 12, 2017 , ... On Saturday, October 21, the Health & ... by Moonlight to raise money for the American Heart Association Heart Walk. Teams of ... will work together to keep their treadmills moving for 5 hours. Treadmills will start ...
Breaking Medicine News(10 mins):