Dear Dick: For the convenience of the readers I am posting the press release here. Good news, just hope I never need it!! JDN
Thursday May 28, 5:52 pm Eastern Time
Company Press Release
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:COHR - news) announced today that it has received FDA clearance of Holmium Laser Resection of the Prostate (HoLRP) for benign prostatic hyperplasia (BPH) 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 difficult. The current ''gold standard'' for treatment of BPH, transurethral resection of the prostate (TURP), uses an electrical loop to carve out 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 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, 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, ablation, incision, excision and coagulation 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.'' Thursday May 28, 5:52 pm Eastern Time |
