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news.Power Medical Interventions, a provider of computer-assisted, power-actuated surgical cutting and stapling products, has filed a 510k application with the FDA requesting marketing clearance for the company's iDrive Intelligent Power Unit detachable Intelligent Surgical Instruments and iConsole monitor. The company plans to launch the iDrive and iConsole products once 510k clearance is received from the FDA.
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According to Power Medical Interventions (PMI), the iDrive Intelligent Power Unit (IPU), a first-of-its-kind breakthrough in operating room instrumentation, is designed to support a variety of minimally invasive procedures.
The iDrive IPU is a novel hand-held, computer-controlled power unit to which any of the company’s intelligent surgical instruments can be attached, offering surgeons a broad range of cutting and stapling configurations by providing increased flexibility, access and precision. In addition, the iDrive IPU is reusable, providing important efficiencies and cost savings for hospitals and health networks, the company claimed.
The iConsole is a proprietary wireless device that communicates directly with the iDrive IPU during surgical procedures to output specific auditory and visual reference information via its speaker and liquid crystal display. Outputs provide surgeons with important information regarding calibration, firing, and instrument and reload type, allowing surgeons to make real-time, critical decisions that may ultimately lead to an improved patient outcome, the company said.
Furthermore, the iConsole can serve as a valuable data collection and reporting system with the potential to be integrated with inventory management systems and electronic medical records to improve operational performance for healthcare organizations, surgery centers and hospitals, the company added.
Michael Whitman, president and CEO of PMI, said: “We believe that the iDrive IPU and iConsole are two of the most powerful and sophisticated surgical instruments to be developed worldwide. Once commercially available, we expect these instruments to contribute significantly to the company’s sales growth as they offer unique capabilities to support minimally invasive surgical procedures that are currently difficult, or not possible, with existing instruments.
“Additionally, we are excited about the potential role that the iDrive IPU, Intelligent Surgical Instruments and iConsole may play in enabling the emergence of natural orifice translumenal endoscopic surgeries which are conducted through the body’s natural openings, minimizing incisions, pain and recovery time.”