Cardica of Redwood City, California is now releasing its MicroCutter XCHANGE 30 cutting/stapling device to the European market. The dual use device, intended for use in laparoscopic and thoracoscopic procedures, allows surgeons to deliver multiple staples without needing to reload cartridges.
The company received European CE Mark clearance back in March and is starting with a slow rollout beginning with hospitals in Switzerland and Austria.
Approximately 60 surgeons have used the XCHANGE 30 in over 220 laparoscopic and thoracoscopic procedures with more than 600 deployments over the last eight months. The MicroCutter XCHANGE 30 has been used in a wide variety of surgical procedures including appendectomies, gastric bypasses, hemicolectomies, gastrectomies, parenchymal or soft organ surgeries (operations on the liver and kidney), lobectomies, and other thoracic and lung surgeries. Recently, it has been used in hysterectomies as well.
Based on the performance of the MicroCutter XCHANGE 30 to date, Cardica believes the XCHANGE 30 is ready to be sold commercially. Cardica is initiating European commercial sales in a well-controlled, focused sales effort in parallel with data collection for a planned US regulatory submission. Cardica will continue to make enhancements and improvements to the MicroCutter XCHANGE 30 based on feedback from surgeons.
Product page: MicroCutter XCHANGE 30…