Power Medical Interventions Inc. said the FDA cleared its 510(k) application for marketing its intelligent iDrive surgical devices, which includes a suite of reusable, self-contained, hand-held devices that can be used to power and control PMI�s existing suite of Digital Loading Units.
The Digital Loading Units include a linear cutter, right-angle linear cutter, and circular staplers. The company�s first generation of technology, the SurgASSIST, required the use of an external power console, flexible drive shaft and separate remote control unit. The company says these functions can now be performed by a single hand-held iDrive unit. The iDrive has been cleared for a broad range of applications in open and endoscopic surgery.
PMI�s Intelligent Surgical Instruments are computer-assisted, power-actuated endomechanical instruments that surgeons use for cutting, stapling and tissue manipulation in a variety of procedures in open surgery and minimally invasive surgery. Compared to conventional endomechanical devices, PMI believes its Intelligent Surgical Instruments offer greater precision and consistency, superior compressive force, improved access to anatomical sites and enhanced ease of use.
The iDrive is the latest addition to the Intelligent Surgical Instruments family and follows the recently launched i60, a 60mm articulating endoscopic linear cutter. These products are controlled by direct-drive motors, motor-control circuits and clinician-feedback technology that have been miniaturized and integrated into a self-contained, hand-held unit. These instruments are operated with digital controls located in the handle and do not require an AC power source. They are powered by proprietary lithium ion batteries.
January 2008