Prosurg Inc Receives U.S. Food and Drug Administration (FDA) clearance for LaserTx- Diode Laser System and Single use fiber optic delivery device for the treatment of Urological & Gynecological disorders in the physician's office.
San Jose, Calif. June 9, 2006--Prosurg Inc announced receipt of marketing clearance from the U.S. Food and Drug Administration (FDA) of LaserTx-- Diode Laser system and single use fiber optic delivery device products for the treatment of Urological & Gynecological disorders in the physician's office.
The LaserTx Diode laser system consists of a small, portable laser system emmitting 805nm or 980nm wavelength for selective absorption in the target tissue designed for controlled tissue coagulation and ablation procedures in physician's office.The Laser System with 980nm wavelength is ideal for endoscopic surgical procedures to ablate soft target tissue due to its high absorption in water. The LaserTx Diode laser system with 805nm wavelength is specifically designed to enhance the laser energy effect and selective absorption in the target tissue by using of photosensitizing agents and dyes. The photosensitizing agents with known absorption peak wavelength profile of 805 -810nm range can be administered in the target tissue. The photosensitizing agent can then be excited using laser light of matching wavelength to achieve selective ablation in the target tissue. The selective laser energy absorption into target tissue infliterated with photosensitizing agent is extreamley efficient and requires low power laser system , ideal for physician's office.The use of diode laser in conjunction with photosensitizing agents for tissue ablation has potential application for treatment of enlarged Prostate, Urethral Strictures, Bladder tumors , Breast tumors, Uterine fibroids, Liver tumors, GI tumors & skin disorders.The fluorescence property of photosensitizing agents and dyes is also benefitial in diagnosis of abnormal tissue growth during endoscopic treatment.
"The LaserTx - Diode laser system emmitting 805 nm wavelength is designed to maximize the tissue ablation effect by carefully matching the peak absorption wavelength profile of photosensitizing agent and wavelength of diode laser light. The low power 805 nm laser energy or photosensitizing agent alone does not have any appreciable tissue ablation effect. The photosensitizing agent is safe, biocompatible and remains inactive in the target tissue, until excited by laser light of specific wavelength. The selective absorption of laser light by the photosensitizing agent in the target tissue, minimizes the risk of accidental tissue damage and loss of laser energy to the surrounding tissue. The use of low power Diode laser in conjunction with photosensitizing agent represents an ideal endoscopic tissue ablation treatment in the physician's office."commented Ashvin Desai President and Chief Executive Officer of Prosurg, Inc." The LaserTx system can be used to diagnose and identify the abnormal tissue growth target , by imaging the fluorescence of photosensitizing agent, followed by selective laser ablation treatment of the target tissue using Diode laser, delivered endoscopically via fiberoptic, under imaging guidance."
The LaserTx - Diode laser system is available in 15 Watts & 25 watts models. The LaserTx - Diode Laser system is also available with Single use, sterile fiber optics delivery device. The single use 400 / 600 micron fiber optics devices are designed with proprietary laser coupler to minimize potential risk of cross contamination from reuse and reprocessing. The LaserTx- Diode laser system is lightweight, portable and compatible with endoscopic delivery devices. The LaserTx system can be used for minimally invasiveendoscopic procedures for treatment of Prostate, Bladder, Uterus, Fibroids , Breast & GI disorders.
About Prosurg, Inc
Founded in 1989, Prosurg, Inc is dedicated to develop, manufacture and market innovative products based on the state of the art technology for treatment of Urological, Uro-Gynecological & gynecological dieases and disorders. Prosurg inc is comitted to provide cost effective treatment options for men's and women's health. For additional information, please visit www.Prosurg.com