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This article was originally published in The Gray Sheet

Executive Summary

AMERICAN SURGICAL TECHNOLOGIES' 3DSCOPE LAPAROSCOPE SHIPMENTS to begin by late April, according to the company. ASTC, which unveiled the laparoscope system at the March 31-April 3 Society for American Gastrointestinal Endoscopic Surgeons annual meeting in Phoenix, Arizona, says that the product will be the first commercially available three- dimensional medical video system for laparoscopic surgery. 3DSCOPE received FDA 510(k) marketing clearance on Dec. 10. Priced at between $60,000-$70,000, the system will cost approximately 1.5 to 2 times more than traditional two- dimensional laparoscopic systems. ASTC currently is establishing a national sales force to market the product and, as a first step, has brought on four to five managers to oversee regional distribution. The firm also intends to hire approximately 40 field sales personnel. The primary component of the system, the 3DSCOPE Stereolaparoscope, "derive[s] two separate images of the object being viewed" from cameras on the left and right sides of the scope. The images are then converted into video signals that are transmitted to the system's image controller. Subsequently, a signal processor "synchronizes, stabilizes and sequentially processes the two video signals" and transfers them to one or more display monitors, which have "specially polarized screens." According to ASTC, the signal processor "precisely synchronizes these transmissions with rapidly switching polarizations of the monitor screen, ensuring that the left polarized images enter the viewer's left eye and right polarized images enter the viewer's right eye." The firm explains that "this is analogous to the way in which the optic nerve presents signals from the left and right eyes." The left-right images alternate so quickly "that the brain experiences them, from second to second, as a single, flicker-free image, just as it integrates the signals from the left and right eyes in natural binocular vision. The single, merged 3-D image is comprised of two separate images, each derived from a different angle of view." The surgeon, who must wear special polarized eyewear, sees "with the same sense of depth perception that he/she would have in open surgery," ASTC claims. The company maintains that the 3DSCOPE "provides a high resolution, full-color...three-dimensional video image of the surgical field" that "speeds procedures, is easier to use and is more accurate than conventional 2-D systems." According to the company, the 3DSCOPE system "differs significantly from proposed 'pseudostereo' approaches in which a single image is merely split into two channels." The 3DSCOPE is ASTC's first product. The firm says it is developing similar systems for arthroscopic and endoscopic indications. The Chelmsford, Massachusetts-based startup's staff has expanded from two to 32 since it was founded in 1991. ASTC's president and chief executive officer, Kenneth Fallon III, previously was president of U.S. operations for Stryker. Chairman and founder Gerald Brecher was a founder and vice president of Norwood, Massachusetts-based Acufex Microsurgical. ASTC has received venture capital funding from groups including Pioneer Capital, Accel Partners, Domain Associates, Oak Investment Partners and Boston University.

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