Other surgical applications that may benefit from the availability of the MicroCutter include vascular transaction, all forms of (inaudible) surgery including liver, kidney, spleen and lung resection. It is probably safe to assume that with this significant change in size and articulation, stapling may find its way into procedures where stapling is currently not an option today.In the ongoing clinical study, four sites have enrolled patients to date. Initially, our clinical plan is to limit the number of enrolling sites with approximately 30 surgeons trained to deploy the MicroCutter XCHANGE 30. Depending on the enrollment rate and the adequacy of patients of follow-up, according to the study protocol we have the ability to expand the number of enrolling sites to a total of ten. The study protocol calls for the enrollment of 160 patients followed for 30 days after their procedure. We expect to complete the clinical trial enrollment for protocol by the end of the calendar year. We may expand the sample size to approximately 200 patients to increase statistical power of the study.
Cardica's CEO Discusses F4Q12 Results - Earnings Call Transcript
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