Cardica touts 1st US use of MicroCutter Xchange 30 after winning expanded indication

Cardica (NSDQ:CRDC) said today its MicroCutter Xchange 30 surgical stapler designed for thoracic surgery procedures was used in the 1st U.S. in-human case after winning expanded 510(k) clearance in January.

The treatment with the stapler was performed by Dr. Robert Cerfolio at the University of Alabama at Birmingham’s Comprehensive Cancer Center, the Redwood City, Calif.-based company said.

“The MicroCutter Xchange 30 represents an important advancement in stapling that has the potential to change the landscape of thoracic surgery as we work to make it less invasive to our patients. With its small size and increased articulation, the MicroCutter Xchange 30’s unique design enables surgeons to maneuver around vessels more easily, potentially reducing dissection while achieving good hemostasis, all through a tiny five-millimeter port,” Dr. Cerfolio said in prepared remarks.

The device was used successfully during robotically assisted cancer surgeries to remove portions of the lung, including lobectomy and segmentectomy procedures, Cardica said. The company claims that the MicroCutter Xchange 30 is the world’s smallest-profile articulating stapler on the market.

“We are proud to support leading thoracic surgeons like Dr. Cerfolio as they constantly strive towards less-invasive approaches and better patient outcomes in thoracic surgery. We are pleased that, with this expanded FDA indication, the MicroCutter XCHANGE 30 is providing new options for surgeons, and enabling the continued progression toward these less-invasive approaches,” CEO Julian Nikolchev said in a prepared release.

In February, Cardica said it pulled the trigger on a 1-for-10 reverse split of its common stock.

Company stockholders approved a series of alternate amendments to effect a reverse stock split that was approved by the company’s board of directors in late January, according to an SEC filing.

In January, Cardica said it re-upped a licensing deal with Intuitive Surgical (NSDQ:ISRG) to include the evaluation and possible development of a cartridge stapler for Intuitive’s da Vinci robot-assisted surgery platform.

In late 2014, Cardica saw shares plunge more than 22% after it suspended the launch of its MicroCutter Xchange 30 surgical stapler so it can focus on improving the product, a move that may also result in a realignment of its operations.

The company said about 220 units of the product were distributed as part of a “controlled commercial launch” to solicit feedback on its performance. Cardica said expects surgeons to continue using the approximately 100 units that remain in the field.

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