The FDA has given 510(k) clearance to Power Medical Interventions (Langhorne, Pennsylvania) for the firm’s iDrive Intelligent Power Unit, detachable Intelligent Surgical Instruments and iConsole device. The company believes that its powered tools, that sport a high level of articulation, can make a lot of difficult laparoscopies much easier to perform.
More about the components from PMI:
A first-of-its-kind breakthrough in operating room instrumentation, the iDrive is designed to support a variety of minimally invasive procedures by offering surgeons a broad range of cutting and stapling configurations combined with increased flexibility, access and precision. The iDrive is a novel hand-held, computer-controlled power unit to which any of the company’s Intelligent Surgical Instruments can be attached. This innovation allows all of PMI’s Intelligent Surgical Instruments to be driven by a single power unit. As a result, hospitals will be able to acquire PMI’s advanced technology platform at less than half of the current cost, which may lead to significant savings for hospitals. The potential now exists for a comprehensive surgical solution that may be significantly less expensive than manual surgical stapling devices. In addition, the iDrive is reusable, easy to use, cost effective, and less wasteful, potentially leading to savings for hospitals and health networks.
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. 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 iDrive and iConsole combination represents a dynamic technology solution which is designed to enable the incorporation of important functional enhancements. PMI intends to aggressively pursue and implement a variety of key enhancements, which ultimately could lead to offering surgeons the world’s first wireless computer mediated platform with unprecedented capabilities such as wireless video processing, Internet access, a patient record interface and controlled tissue compression software.