Surgical devices maker Cardica (CRDC) has commenced enrolling patients in a European clinical trial designed to evaluate its Microcutter product line. The company is developing the Microcutter line of novel endoscopic stapling devices for use in a variety of surgeries that require cutting and stapling.
Cardica noted that the first batch of patients have been enrolled and discharged from the first two investigational sites. The company plans to enroll up to 200 patients across up to 10 European sites and evaluate patients at the time of discharge and after 30 days following surgery.
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 is also developing the MicroCutter XCHANGE 30, a cartridge based microcutter device.
The single-arm, multi-center trial is evaluating safety outcomes of the MicroCutter XPRESS 30 and the MicroCutter XCHANGE 30 devices. The MicroCutter devices will be used for transections, resections and anastomoses during gastrointestinal procedures.
Data from this study will be compared with historical adverse results (including events such as staple line leakage, bleeding and infections) for similar procedures executed with existing stapling devices. Cardica plans to include the results of this trial in its application to the U.S. Food and Drug Administration (“FDA”) for the commercialization of the MicroCutter devices.
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 CABG surgery and has sold over 37,000 units globally. Cardica competes with larger players such as Johnson & Johnson (JNJ) and Covidien (COV) in the laparoscopic stapling and sealing devices market.
Cardiac, in September 2011, cut a distribution deal with Century Medical, a leading supplier of medical equipment in Japan, for its Microcutter product line. The agreement provides Century Medical with exclusive rights to distribute the Microcutter products in Japan.
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