Laserscope receives FDA clearance for new higher-power surgical laser system.SAN JOSE, Calif.--(BW HealthWire)--June 11, 1997--Laserscope (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :LSCP LScP left scapuloposterior (position of fetus). ) today announced that it received clearance from the 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. ) to market a new, higher-power version of its 800 Series Dual-Wavelength KTP/YAG(R) Surgical Laser System. "We believe that the new higher-power system will add to the efficiency of a number of surgical procedures. To our knowledge, no one else has been able to technically achieve KTP laser energy at the power levels that our R&D design team has successfully attained," said Robert V. McCormick, Laserscope President & CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. . The new configuration boosts KTP energy levels to 50 watts and delivers 100 watts of Nd:YAG energy. The system has applications in gynecology, plastic surgery, thoracic surgery, and especially in urology. A new study by researchers at the Mayo Clinic using the new higher-power system, reported in the May 1997 issue of the medical journal Urology, concludes: The higher-power KTP laser "allows technically easy, safe, rapid, and hemostatic removal of canine prostatic tissue in vivo. Furthermore, there is no difference in the efficacy of KTP laser vaporization between human and canine cadaver prostates. These findings suggest that KTP laser vaporization may be as effective in living human prostates as it is in living dogs, and thus it may be a useful technique in the surgical treatment of human benign prostatic hyperplasia benign prostatic hyperplasia n. Abbr. BPH A nonmalignant enlargement of the prostate gland commonly occurring in men after the age of 50, and sometimes leading to compression of the urethra and obstruction of the flow of urine. ." The study, entitled "High-Power Potassium-Titanyl-Phosphate Laser Vaporization Prostatectomy Prostatectomy Definition Prostatectomy refers to the surgical removal of part of the prostate gland (transurethral resection, a procedure performed to relieve urinary symptoms caused by benign enlargement), or all of the prostate (radical prostatectomy, in Living Canines and in Human and Canine Cadavers," also noted that the higher-power KTP laser procedure "technically appears to be as simple as electrosurgical techniques and gives the operator excellent visual control over precisely which tissue is removed and which tissue is left intact. In other words Adv. 1. in other words - otherwise stated; "in other words, we are broke" put differently , with KTP laser vaporization, what one sees is very nearly what one gets... (Higher-power KTP laser vaporization) appears to be a very user-friendly laser prostatectomy technique and deserves serious consideration in humans." The study was authored by Randall S. Kuntzman, M.D., Reza S. Malek, M.D., David M. Barrett David M. Barrett is a professor of political science at Villanova University and author of "The CIA and Congress: The Untold Story from Truman to Kennedy" (2005), Lyndon B. , M.D., and David G. Bostwick, M.D. of the Department of Urology and Section of Surgical Pathology at the Mayo Clinic in Rochester, Minn. It has been estimated that more than 25 million men worldwide exhibit some symptoms of BPH BPH abbr. benign prostatic hyperplasia BPH Benign prostatic hypertrophy, a very common noncancerous cause of prostatic enlargement in older men. , of which 3 million will probably seek some form of medical treatment. Laserscope's 800 Series KTP/YAG Surgical Laser System is designed for the hospital market. It is a dual-wavelength system that can surgically cut, vaporize and coagulate coagulate /co·ag·u·late/ (-lat) to undergo coagulation. co·ag·u·late v. To change from the liquid state to a solid or gel; clot. tissue without disruption to adjacent areas. The new higher-power configuration is expected to be available in the fall as a field upgrade to approximately 1,000 installed Laserscope 800 Series Surgical Laser Systems throughout the world. Laserscope designs, manufactures, sells and services on a worldwide basis an advanced line of medical laser systems and related energy delivery devices for the office, outpatient surgical center and hospital markets. Laserscope's Ascent Medical Systems (AMS AMS - Andrew Message System ) family of products includes operating and treatment room lights, ceiling-mounted equipment organizers, video systems, operating room tables and centralized smoke evacuation systems. Statements in this announcement about future results are preliminary and based on partial information and assumptions. Except for the historical information presented, the matters discussed in this announcement contain forward-looking statements that involve risks and uncertainties, including the ability to introduce new products successfully, the development and rate of growth of new and existing procedures and markets, the impact of competitive procedures, technologies and products, and other risks detailed from time to time in the company's public disclosure filings with the U.S. Securities and Exchange Commission (SEC). Copies of the company's most recently filed Forms 10K and 10Q are available from Laserscope's Investor Relations Department. CONTACT: Laserscope Richard Wood (IR/Media), 408/943-0636 Dennis LaLumandiere (Financial), 408/943-0636 or Hilary Kaye Associates Hilary Kaye/Shelle Murach, 714/851-5150 |
|
||||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion