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Laserscope Announces FDA Approval of New Surgical System
for the Treatment of BPH - San Jose, Calif. (May 10, 2001)
Laserscope (Nasdaq: LSCP) today announced that it has received approval from the U.S. Food and Drug Administration to market its new high power KTP laser system NIAGARA specifically for the treatment of Benign Prostatic Hyperplasia (BPH).
In commenting on the news, Eric Reuter, Laserscope President and CEO said, "We are very excited about the approval and encouraged that the FDA has cleared our new system specifically for this indication in such a short period of time. We now plan to proceed with our marketing launch and expect to begin commercial shipment of the product later this year."
Reuter added, "As I have mentioned in previous communications, we believe that this procedure, known as photo-selective vaporization of the prostate, or PVP, will be ultimately recognized as the best treatment available for this disease. Our three-year follow-up clinical results will be presented by Dr. Reza Malek of the Mayo Clinic in a podium presentation the upcoming American Urology Association (AUA) meeting in Anaheim, California.
These results and the immediate post-operative clinical results show that the two major clinical measurements of effectiveness (flow rate and AUA symptom score improvement) are as good or better than any other treatment available, including those published for the current gold standard procedure, trans-urethral resection of the prostate (TURP).
This by itself is a great accomplishment. Even more exciting, is that in addition to these compelling clinical symptom improvements, our procedure also has demonstrated a far smaller risk of side-effects and patients required limited or no catheterization after they were treated. The procedure is also minimally invasive and can be done on an outpatient basis."
"Essentially, we are offering a "no compromises" solution," continued Reuter. "Other procedures and technologies have been shown to involve significant risks or trade-offs and either the patient or the physician must make concessions in receiving or delivering the best care.
With our treatment solution, we are demonstrating in our clinical trials that neither the patient nor the physician need to compromise. The patients get immediate symptom relief and the physicians have a procedure and system that is fast, easy to learn, has reimbursement codes already established, and most importantly, delivers the best possible treatment for their patients."
Except for historical information presented, the matters discussed in this announcement may contain forward-looking statements that involve risks and uncertainties. These risks are detailed from time to time in the Company's public disclosure filings with the U.S. Securities and Exchange Commission (SEC). Copies of Laserscope's most recent forms 10K and 10Q are available upon request from its Investor Relations Department.
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