SAN JOSE, Calif., May 10 -- Laserscope said that it has received approval from the US Food and Drug Administration to market its new high power KTP laser system specifically for the treatment of Benign Prostatic Hyperplasia (BPH). 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 at 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."