Covidien's iDrive powered stapling system granted FDA 510(k) clearance

Covidien (NYSE: COV), a leading global provider of healthcare products and recognized innovator in surgical stapling applications, today announced 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the iDrive™ powered stapling system. This reusable stapling platform is battery-powered, enabling one-handed push-button operation of all primary controls and a reduction in the required firing force when compared to traditional endomechanical surgical staplers. The iDrive system also incorporates design features intended to minimize the effect on the environment by scaling back the size of hospital inventories and reducing medical waste.

“Covidien will lead the evolution of the intelligent surgical tools category by advancing innovative products that improve patient outcomes, reduce costs and offer environmentally-friendly benefits.”

"Clearance of the iDrive system launches a new era of intelligent devices that deliver superior ergonomics and improved access,¹" said Ralph Corradi, Franchise Vice President, Endomechanical Devices, Covidien. "Covidien will lead the evolution of the intelligent surgical tools category by advancing innovative products that improve patient outcomes, reduce costs and offer environmentally-friendly benefits."

The iDrive system consists of the powered handle - a rechargeable battery-powered, multi-patient reusable, hand-held stapler - and the right-angle linear cutter (RALC). The RALC is a single-use reload, combining stapling and cutting functionality. When fired, it deploys 32 titanium DST Series™ staples in two double-staggered rows and an integrated knife bisects the underlying tissue. With the push of a single button, the handle's high-speed brushless motor delivers 90 pounds of firing force at an angle that is perpendicular to a curved shaft. This geometry helps gain deeper access to, and better visibility within, the pelvis during low anterior resections. The roll out of the iDrive system, Covidien's initial offering in its Power Devices portfolio, is scheduled for the first calendar quarter of 2011 at specific surgical sites that focus on low anterior resection procedures.

"At Covidien, we develop products and technologies designed to enable healthcare institutions to achieve clinical excellence while simultaneously meeting healthcare economic goals," said Dr. Richard Toselli, Chief Medical Officer, Surgical Devices, Covidien. "The iDrive system is a reusable platform that can safely and reliably serve the needs of patients, while improving operating room inventory management efficiencies and reducing medical waste generated from disposable products."