Covidien plc (NYSE:COV) won 510(k) clearance from the Food & Drug Administration for its iDrive surgical stapling system.
The Mansfield, Mass.-based medical products maker designed the device to give doctors better access to the body during colorectal surgery.
The open* surgery system sports a "right-angle linear cutter," which enables a surgeon to cut and staple at a perpendicular angle to the device, and push-button delivery enabled by battery power, according to the company.
“Clearance of the iDrive system launches a new era of intelligent devices that deliver superior ergonomics and improved access," said endomechanical devices franchise vice president Ralph Corradi in prepared remarks.
The company said it plans to launch the device as the first offering in its "Power Devices" portfolio in the first quarter of 2011.
Rick Wise, an analyst for Leerink Swann wrote in a note to investors that this product is "relatively small" for Covidien — possibly generating about $5 million to $10 million of incremental revenue per year — but the overall powered product line is "perhaps one of the most important new product lines that COV will introduce over the next few years."
"Over time, as the various ‘powered’ products are introduced in all the required varieties and sizes, they should help substantially differentiate COV’s offering from the competition and possibly drive some market share gains in what is COV’s ‘bread and butter’ laparoscopic surgery franchise," Wise said.
The 20-year-old laparoscopy market is still dominated by manually operated devices, he said.