Bovie Medical Corporation Announces FDA Clearance to Market the BovieButton(TM).MELVILLE, N.Y. -- Bovie Medical Corporation (the "Company") (Amex: BVX BVX Bulk Viscosity of Xenon ), a manufacturer and marketer of electrosurgical products, today announced that it has received U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) clearance to market the BovieButton(TM) Remote Handswitch (BovieButton(TM)). The BovieButton(TM) is a device designed to eliminate the foot pedal and cables associated with standard electrosurgical generators found in all GI labs. The ergonomically designed button was developed after a review of time-motion studies of physicians and nurses during GI procedures. Dr. Peter Pardoll, a member of Bovie's Scientific Advisory Board, led focus groups of gastroenterologists and GI lab assistants whose main complaint was the myriad of foot pedals and cables which can result in contamination of the nurses hands in moving the pedals, difficulty in placement of the pedal in a darkened dark·en v. dark·ened, dark·en·ing, dark·ens v.tr. 1. a. To make dark or darker. b. To give a darker hue to. 2. To fill with sadness; make gloomy. 3. room as well as resultant safety problems of the physician and nurse taking their eyes off the lesion on the video screen to find the pedal and losing sight of the polyp polyp, in medicine, a benign tumor occurring in areas lined with mucous membrane such as the nose, gastrointestinal tract (especially the colon), and the uterus. Some polyps are pedunculated tumors, i.e. to be removed. The device eliminates the need for a footswitch, which can be both expensive and contaminated contaminated, v 1. made radioactive by the addition of small quantities of radioactive material. 2. made contaminated by adding infective or radiographic materials. 3. an infective surface or object. . The BovieButton(TM) is disposable and attached where the physician feels most comfortable for activation of the generator. This is the first of several products being developed by Bovie for the GI market. "It made sense to move the pedal to the scope by placing the activating buttons on the scope head, comparable to a surgeon's use of an electrosurgical pencil," said Dr. Pardoll. "Using our GI Advisory Team, the buttons were modified to improve safety and comfort in the GI lab and ensure that the active cord will not disconnect from the snare snare (snar) a wire loop for removing polyps and tumors by encircling them at the base and closing the loop. snare n. or hot biopsy forceps biopsy forceps Surgery A disposable forceps used during minimally invasive GI and urologic endoscopy for collecting biopsies . The BovieButton(TM) is compatible with all snares and eliminates the need for the generator's active cord, which is another area of safety concern for inadvertent disconnection." Andrew Makrides, president of Bovie Medical, stated, "We are optimistic op·ti·mist n. 1. One who usually expects a favorable outcome. 2. A believer in philosophical optimism. op about the potential of the BovieButton(TM). The BovieButton(TM) is another example of an innovative device created by our engineers in collaboration with doctors, nurses and technicians. Developing proprietary products for niche markets that improve the efficiency and safety of surgeons continues to be Bovie's main emphasis. As previously disclosed, Bovie is directing significant effort and resources towards the expansion of its family of products in order to meet the needs of the rapidly changing medical industry." This document may contain some forward looking statements, particularly regarding operational prospects in 2006 and beyond, which involve a number of risks and uncertainties that could cause actual results to differ materially. These risks are listed from time to time in the Company's SEC filings. |
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