Power Medical InterventionsÂ®, Inc. (PMII.OB), the world’s only provider of computer-assisted, power-actuated surgical cutting and stapling products, announced yesterday that the company has received clearance from the U.S. Food and Drug Administration (FDA) for its 510(k) application for marketing iDrive Intelligent Power Unitâ„¢, a detachable Intelligent Surgical Instruments and iConsoleâ„¢. As a leader in developing and commercializing Intelligent Surgical Instrumentsâ„¢, Power Medical Interventions intends to launch the iDrive, Intelligent Surgical Instruments and iConsole products for commercial sale, effective immediately.
The iDrive is designed to support a variety of minimally invasive procedures by offering surgeons a broad range of cutting configurations and is a first-of-its-kind breakthrough in operating room instrumentation. The iConsole is a proprietary wireless device that communicates directly with the iDrive during surgical procedures to output specific auditory and visual reference information via its speaker and liquid crystal display. In addition to its broad functionality, the iDrive is reusable, easy to use, cost effective, and less wasteful, potentially leading to savings for hospitals and health networks.
Michael Whitman, president and chief executive officer of Power Medical Innovations, stated, â€œThe iDrive and iConsole are the latest examples of Power Medical Interventionsâ€™ commitment to pioneering continued innovation in the surgical arena.â€ He added, â€œThese instruments will deliver critical advantages to surgeons offering single handed use, flexibility, and access to remote anatomical sites. PMI’s Intelligent Surgical Instruments have applications in open surgery, minimally invasive surgery and the emerging field of natural orifice translumenal endoscopic surgery.â€