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Cardica Suspends Enrollment


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Surgical devices maker Cardica reported that it has halted enrollment in the European clinical trial for its endoscopic stapling device MicroCutter XPRESS 30 as the device failed to perform satisfactorily in thicker tissue.

The trial has been designed to evaluate the safety outcomes of the MicroCutter XPRESS 30. The company noted that it has isolated the underlying cause which requires changes to the device to boost its performance.

Separately, Cardica stated that it plans to begin clinical study for MicroCutter XCHANGE 30, a cartridge based microcutter device, by the end of first-quarter 2012. While the company is prioritizing the development of this device, it will also make the necessary changes to MicroCutter XPRESS 30 concomitantly. The MicroCutter XPRESS 30 was initially planned as the first product in the microcutter product line which Cardica intended to commercialize. 

Cardica has also mentioned that, given limited financial resources, it has suspended the development of other potential products in the planned microcutter family until it completes the development of MicroCutter XCHANGE 30 and secures additional financial resources. 

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 that require cutting and stapling.

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.

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 - Free Report) and Covidien in the laparoscopic stapling and sealing devices market.

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