Cardica announced it has filed regulatory documents with the U.S. Food and Drug Administration to obtain marketing clearance for the MicroCutter XCHANGE 30, a cutting and stapling device designed for use in multiple open and minimally invasive surgical procedures. The device features a cross-sectional area that is six times smaller than conventional surgical staplers and articulates up to 80 degrees in each direction. Greater access is provided by the lower profile through a 5 mm trocar.
Cardica’s submission to the FDA includes results from the company’s recently completed MicroCutter European Trial (MET1). The MicroCutter XCHANGE 30 met the primary endpoint in the MET1 study, which was freedom from MicroCutter-related severe adverse events when compared with historical controls from the medical literature; only one event occurred out of 160 patients and 423 deployments.
Pending FDA market clearance, Cardica plans to introduce the MicroCutter XCHANGE 30 in the United States, which is the world’s largest surgical stapling market. The device is currently available in select centers in Europe.
Cardica is a designer and manufacturer of proprietary stapling and anastomotic devices for cardiac and laparoscopic surgical procedures. The company’s technology portfolio is intended to minimize operating time and enable minimally invasive and robot-assisted surgeries.
For more information, visit www.cardica.com
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