Jan 7 2008
Vision-Sciences, Inc., announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration ("FDA") to market its new advanced digital, video-based flexible Cystoscope, which is used in conjunction with an integrated “built-in” light source, eliminating the need for a separate camera head, light guide cable and optical coupler.
Following the ENT (Ear, Nose and Throat) and TNE (Transnasal Esophagoscopy) endoscopes that were recently unveiled, the Cystoscope is the third in the series of uniquely advanced digital endoscopy platforms introduced by Vision-Sciences. These lightweight videoscopes facilitate diagnostic and therapeutic procedures with the introduction of the world’s smallest diameter videoscope insertion tube containing a high resolution, miniature CCD (charge coupled device) camera at the tip of the insertion tube, offering a sharp, high definition, vibrant, full screen image.
Moreover, these videoscopes are also the first in the world that do not contain difficult-to-clean operating channels that are associated with scopes from other manufacturers. Instead, Vision-Sciences’ scopes are used in combination with the Company’s patented, disposable, sterile Slide-On® EndoSheath® technology that covers the entire scope. The proprietary EndoSheath® technology not only isolates the endoscope from the patient, but contains a disposable operative channel. This prevents instrumentation and patient tissue biopsies from coming in contact with the reusable scope, unlike when passed through the built-in channel of conventional scopes from other manufacturers. The EndoSheath® Technology eliminates the need for elaborate high-level disinfection between procedures, leading to rapid equipment turnover, limiting capital investment for additional scope inventory, reducing staff exposure to toxic chemicals, and dramatically lowering repair and maintenance costs.
The CST-5000 flexible video cystoscope provides vivid images of the internal structures of the bladder.
“We believe this is a breakthrough in endoscope technology,” stated Vision-Sciences' CEO, Mr. Ron Hadani. “Our new digital video Cystoscope with the EndoSheath® technology is poised to ultimately replace the pervasive old, fiber-optic technology. While gastroenterologists have used costly conventional video endoscopes for years, high conversion costs forced other specialties to use the old ‘eye-to-the-eyepiece’ fiber-optic technology. This is the first time urologists will have the opportunity to use the world’s best videoscope, which is uniquely combined with the practice-efficiency of the EndoSheath® Technology. We plan to aggressively promote this revolutionary product, and drive rapid adoption of video technology throughout the global urology community.”
Vision-Sciences remains focused on delivering the best in endoscopy infection control, specifically designed for a demanding health care environment. Several months ago, Vision-Sciences successfully completed viral microörgranism “barrier testing” in accordance with FDA’s guidance for the videoscope EndoSheath® Technology, proving that the EndoSheath® barrier is effective to microörganisms as small as 27 nanometers – the FDA’s benchmark for barriers. Dangerous microorganisms such as the AIDS virus (80-120 nanometers), Hepatitis-C (30-60 nanometers) or Herpes Simplex Virus (150-200 nanometers) are significantly larger.
“With increasing global vigilance on the prevention of hospital acquired infections, we believe our EndoSheath technology offers unique and relevant advantages to multitudes of patients and healthcare practitioners,” stated Mr. Carlos Babini, Executive Vice President of Vision-Sciences. “We tested this innovative EndoSheath® barrier with nano-level scrutiny, and we remain committed to continue research on the clinical efficacy of EndoSheath® Technology, such as the recent study concluded by Dr. Alvarado at the University of Wisconsin.”
“We leave incremental endoscope improvements to others,” stated Mr. Hadani. “At Vision-Sciences we are transforming video-based endoscopy with meaningful integration of enabling components, to provide extraordinary vision and superior endoscopic systems, facilitating quality healthcare.”