Home » Cardica Halts Enrollment in EU Trial of Surgical Device
Cardica Halts Enrollment in EU Trial of Surgical Device
Cardica announced Monday it is suspending 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 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.
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