Cardica Inc.(CRDC) announced the suspension of enrollment in its European clinical trial of the MicroCutter XPRESS 30 due to a small subset of deployments where the XPRESS 30 did not perform satisfactorily in thicker tissue.
The company said that it has isolated the underlying cause, which requires modifications to the product. There have been no serious adverse events and all patients have had an uneventful postoperative course as it relates to the use of the MicroCutter.
Cardica noted that it has reprioritized the development activities of its MicroCutter product line to emphasize the development of the MicroCutter XCHANGE 30. In addition to the acceleration of development for the XCHANGE 30, the company intends to pursue modifications of the XPRESS 30 concurrently.
Cardica also noted that it plans to continue the trial with the XCHANGE 30, a cartridge-based microcutter device with a 5 millimeter shaft diameter, by the end of the first calendar quarter of 2012, once this device completes development and design verification, and Cardica is able to apply Conformite Europeenne Mark to the device.
The surgical indications for the trial will not change, with thicker tissue resections and anastomosis intended to be added in the latter part of the trial once the XPRESS 30 modifications have been completed and verified.
In light of Cardica's limited financial resources, Cardica has suspended development of other potential products in its planned microcutter product line until the development of XCHANGE 30 has been completed and additional financial resources have been obtained, the company said.
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