The Food and Drug Administration granted marketing clearance Tuesday for Power Medical Interventions Inc.’s new surgical instrument, which will be used in computer-assisted medical procedures.
The Langhorne, Pa., medical-device company said the i60RL is the first FDA-approved reverse pivot linear cutter, which is designed to improve medical outcomes by providing surgeons with greater access to key anatomical sites that are currently difficult to reach. The device was approved for surgical applications throughout the digestive tract.
Power Medical (NASDAQ:PMII) intends to launch the product in April 2009.
In addition, Power Medical received approval from an independent institutional review board to conduct a study on the effectiveness of the i60RL in the treatment of gastroesophageal reflux disease The study will be conducted at the University of Chicago and will led by Dr. John Alverdy, a professor of surgery and head of the minimally invasive lab at the college.
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