iDrive Intelligent Power Unit™ With iConsole™ FDA Approved
LANGHORNE, Pa., (GLOBE NEWSWIRE) — Power Medical Interventions®, Inc. (OTCBB:PMII), a developer of Intelligent Surgical Instruments™, announces that the U.S. Food and Drug Administration (FDA) has cleared its 510(k) application for marketing its iDrive Intelligent Power Unit™, detachable Intelligent Surgical Instruments and iConsole™. Based on the marketing clearance by the FDA, Power Medical Interventions (PMI) intends to launch the iDrive, Intelligent Surgical Instruments and iConsole products for commercial sale, effective immediately.
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.
"The iDrive and iConsole are the latest examples of Power Medical Interventions' commitment to pioneering continued innovation in the surgical arena. These 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 (NOTES)," said Michael Whitman, president and chief executive officer of PMI.
"At the same time, these new instruments are designed to reduce healthcare costs and improve hospitals' operational efficiency. Our hospital customers will now be able to acquire PMI's advanced stapling technology at a greatly reduced cost. The iDrive/iConsole combination offers a single power unit to drive all of our Intelligent Surgical Instruments, eliminating the need to purchase multiple power units. The cost savings is passed along to our hospital customers. Furthermore, the reusable and autoclavable nature of these instruments plays a key role in helping to reduce medical waste, offering additional meaningful benefits to our hospital customers."