MANSFIELD – Medical device maker Covidien PLC landed 501(k) clearance by the U.S. Food and Drug Administration for its reusable iDrive Ultra powered stapling system.
The system is the only reusable, battery-operated endoscopic surgical stapler in the world, according to Covidien, which announced the approval Tuesday.
The iDrive Ultra system is the second in Covidien’s line of powered stapling devices and the first product completely compatible with the company’s entire portfolio of Endo GIA reloads with Tri-Staple technology.
According to the company, the one-handed, push-button system eliminates the need for manual firing force and improves maneuverability, compared to traditional endomechanical staplers.
“The newest addition to our line of battery-powered devices delivers optimal functionality due to the valuable feedback surgeons have provided,” Paul Hermes, vice president and chief technology officer of Covidien Surgical Solutions, said in a statement.
“We work closely with surgeons to develop products that not only improve patient outcomes, but also make surgery safer, easier and more efficient for surgeons,” added Hermes. “The iDrive Ultra powered stapling system is another example of Covidien’s dedication to innovation and to advancing clinically proven solutions.”
The company is projecting that the system will be available in the United States beginning in the fourth quarter of 2012.