Coherent Inc. Announces FDA Clearance of Holmium Laser Prostatectomy with the VersaPulse Select Holmium Laser.SANTA CLARA, Calif.--(BW HealthWire)--May 28, 1998-- Coherent, Inc.(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 :COHR COHR Congolese Observatory of Human Rights ) announced today that it has received 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 of Holmium holmium (hōl`mēəm) [Lat.,=Stockholm], metallic chemical element; symbol Ho; at. no. 67; at. wt. 164.9304; m.p. about 1,474°C;; b.p. about 2,425°C;; sp. gr. 8.78 at 25°C;; valence +3. Laser Resection of the Prostate (HoLRP) for 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. (BPH BPH abbr. benign prostatic hyperplasia BPH Benign prostatic hypertrophy, a very common noncancerous cause of prostatic enlargement in older men. ) with the VersaPulse(R) Select(TM) holmium laser. BPH is a condition that affects 18.5 million men in the U.S., Europe and Asia-Pacific. BPH is an enlargement of the prostate gland that occurs with aging, creating an obstruction and making urination urination Process of excreting urine from the bladder (see urinary system). Nerve centres in the spinal cord, brain stem, and cerebral cortex control it through involuntary and voluntary muscles. The need to void is felt when the bladder holds 3. difficult. The current "gold standard" for treatment of BPH, transurethral resection of the prostate Transurethral resection of the prostate (TURP) Surgical removal of a portion of the prostate through the urethra, a method of treating the symptoms of an enlarged prostate, whether from BPH or cancer. Mentioned in: Prostate Cancer (TURP TURP transurethral resection of the prostate. TURP abbr. transurethral resection of the prostate Transurethral resection of the prostate (TURP) ), uses an electrical loop to carve out to make or get by cutting, or as if by cutting; to cut out. - Shak. See also: Carve the obstructing tissue. TURP is performed approximately 250,000 times a year in the United States alone and, while TURP is effective in removing tissue and providing a good surgical result, it is associated with significant morbidity. Current literature indicates that 20-30% of TURP patients will have some complication, including 5-10% requiring blood transfusions. Dr. Bernard Couillaud, President and Chief Executive Officer of Coherent, said, "During the FDA clinical trial, which lasted two years, 60 men were treated for BPH with the VersaPulse Select laser system and 60 were treated with the traditional TURP method. The results are impressive. We believe that the HoLRP procedure provides surgical results equivalent to TURP with clear benefits for the surgeon and the patient. HoLRP is virtually bloodless, reducing the risk of transfusion and post-operative catheter time. The procedure can be done as a day case or in a 23-hour facility. Recovery time is significantly reduced and patients report greater satisfaction with the procedure. We are proud to be the first company to have FDA clearance for this treatment using a holmium laser." "The HoLRP has replaced standard TURP completely and unreservedly in our hospital. There is nothing out there that has been shown to be better," said Peter Gilling, MD, Consulting Urologist at Tauranga Hospital, Tauranaga, New Zealand. HoLRP offers significant advantages over other currently available treatments for BPH. Drug therapy, while effective in some cases, must be continued indefinitely and may lose effectiveness over time. Also, because patients may be using other drugs, potential interaction is a concern. Other new minimally invasive devices using energy sources such as radio frequency, interstitial diode and microwave, essentially cook the prostate tissue and allow it to slough over time. This process causes lengthy post-operative irritation and prolonged catheter time. Often the end result cannot be evaluated until months following the procedure. Holmium laser 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, provides immediate objective surgical results identical to TURP with significant improvement in complication rate. "The Holmium laser represents the pinnacle of laser technology in urology as of 1998. This is the only operation for BPH that I am doing", says John Kabalin, MD, Scottsbluff Urology Associates, Scottsbluff, Nebraska, formerly Assistant Professor of Urology, Stanford University School of Medicine Stanford University School of Medicine is affiliated with Stanford University and is located at Stanford University Medical Center in Stanford, California, adjacent to Palo Alto and Menlo Park. , and a recognized expert on surgical laser technology and applications. The VersaPulse Select Holmium laser is also cleared for other urologic procedures including treatment of tumors, strictures and urinary lithotripsy. It can be used in other surgical specialties for procedures involving vaporization vaporization, change of a liquid or solid substance to a gas or vapor. There is fundamentally no difference between the terms gas and vapor, but gas is used commonly to describe a substance that appears in the gaseous state under standard conditions of , ablation, incision, excision and coagulation coagulation (kōăg'y lā`shən), the collecting into a mass of minute particles of a solid dispersed throughout a liquid (a sol), usually followed by the precipitation or of soft tissue."I would envision that every significant urology department will have a Holmium laser at their disposal. It is a basic tool for stones and BPH, two of the most common conditions urologists treat", remarks James Lingeman, MD, Director of Research, Methodist Hospital Institute for Kidney Stone Disease, Indianapolis, Indiana. Dr. Couillaud concluded, "This is undoubtedly good news for our medical group in the long term. Our experience is that there is always a lead-time for new medical laser applications, as doctors need time to become familiar with the procedure and be properly trained. As a result, we do not expect sales in the short term to be significantly affected as a result of the FDA clearance." "Safe Harbor" Statement Under the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and The statements in this press release that relate to future plans, events or performance are forward-looking statements that involve risks and uncertainties, including risks associated with uncertainties related to currency adjustments, contract cancellations, manufacturing risks, competitive factors, uncertainties pertaining to customer orders, demand for products and services, development of markets for the Company's products and services and other risks identified in the Company's SEC filings. Actual results, events and performance may differ materially. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The Company undertakes no obligation to release publicly the result of any revisions to these forward-looking statements that may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. Readers are encouraged to refer to the risk disclosures described in the Company's reports on Form 10-K, 10-Q and 8-K, as applicable. Founded in 1966, Coherent, Inc. is a Standard & Poor's SmallCap 600 company and a world leader in the design and manufacture of lasers and systems for medical, scientific and commercial applications. Please direct any questions to Robert J. Quillinan, Executive Vice President and Chief Financial Officer at 408/764-4168. For more information about Coherent, visit our Web site at http://www.cohr.com for product and financial updates. To receive a full text copy of this press release by fax, please call 800/549-0676.
CONTACT: Coherent Inc.
Robert J. Quillinan, 408/764-4168
|
|
||||||||||||||||||

lā`shən)
Printer friendly
Cite/link
Email
Feedback
Reader Opinion