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news.Power Medical Interventions, a developer of surgical instruments, has announced that the FDA has cleared its 510(k) application for marketing its patented i60RL Intelligent Surgical Instrument.
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According to the company, the i60RL Intelligent Surgical Instrument is the world’s first reverse pivot linear cutter, designed to improve medical outcomes by providing surgeons with greater access to important anatomical sites that are currently difficult to reach.
The i60RL will be available for applications throughout the digestive tract. The company intends to launch the product in April 2009.
In addition, Power Medical Interventions (PMI) received approval from an Institutional Review Board to conduct a study on the effectiveness of the i60RL in the treatment of gastroesophageal reflux disease.
Michael Whitman, president and CEO of PMI, said: “The i60RL is a unique and proprietary addition to PMI’s line of Intelligent Surgical Instruments and further validates the possibility for PMI’s technology to facilitate the creation of new clinical indications in minimally invasive surgery.”