Surgical devices maker Cardica Inc has reportedly completed the key internal design verification process necessary for applying the European CE Mark to its Microcutter XPRESS 30 surgical cutting and stapling device.
Cardica’s internal verification process is aimed at meeting all regulatory requirements in the U.S. and Europe. Successful completion of this phase represents a key step in the commercialization of the Microcutter XPRESS 30 device in Europe. The California-based company intends to begin the first human use of the device in select European centers starting July 2011.
Cardica's Microcutter product line has been geared to offer genuine multi-fire endoscopic stapling for a number of procedures, such as thoracic, colorectal as well as general surgery. The Microcutter line-up is expected to cut and staple on a continuous basis, thereby permitting the surgeon to complete consecutive deployments without removing the device to reload the cartridge.
The Microcutter XPRESS 30 is the first product in the Microcutter family which Cardica intends to market. The company, in March 2011, stated that it plans to conduct a partial release of the device to about 20 to 30 surgeons in the U.S. in mid-2011, contingent upon the 510(k) clearance from the Food and Drug Administration (“FDA”).
The Microcutter XPRESS 30 has a diameter of only 8 millimeters (mm), compared to other commercialized stapling products, which have a diameter of 12 mm or more. The smaller diameter of the expected Microcutter lineup permits access through smaller-sized, less-intrusive ports and through trocars used for other surgical tools needed for laparoscopic surgery.
Cardica makes stapling devices for endoscopic and cardiac surgery procedures. Its proprietary technology is designed to reduce operating time and enable minimally-invasive and robot-assisted surgeries.
The company markets its automated anastomosis systems for coronary artery bypass graft (“CABG”) surgery and has sold over 34,500 units globally. Cardica competes with larger players such as Johnson & Johnson (JNJ - Free Report) and Covidien in the laparoscopic stapling and sealing devices market.