American Medical Systems Announces Large-Scale, Physician-Led Registry of Penile Implants

MINNETONKA, Minn., June 15, 2011 /PRNewswire/ --  American Medical Systems® (AMS) (NASDAQ: AMMD), a leading provider of world-class devices and therapies for male and female pelvic health, announced today the commencement of a major global registry of penile prosthetic outcomes.  The registry, entitled PROPPER (Prospective Registry of Outcomes with Penile Prosthesis for Erectile Restoration), is led by a team of prominent urologists seeking to better characterize patient satisfaction associated with modern penile prosthetic implants.

PROPPER is a large-scale observational registry expected to enroll over 1,000 men diagnosed with erectile dysfunction (ED) for whom an AMS penile prosthesis is recommended by their physician.  Initially, over ten sites will be involved in the research.  

Patient enrollment has started and Gerard D. Henry, MD, of Regional Urology in Shreveport, LA, was one of the first investigators to enroll.  "This registry is the first of its kind," he explained.  "I am excited about these outcome measures that will add to the scientific literature and ultimately allow patients and healthcare professionals to continue to make informed choices on treatment options."

The PROPPER registry seeks to better understand real-world outcomes for men undergoing penile implant surgery to treat erectile dysfunction.  Using questionnaires as well as electronic data collection, investigating physicians will prospectively measure patient responses at regular intervals over a one- to five-year period.  The physician researchers have identified key metrics for the study including device effectiveness, durability, complications and patient satisfaction; quality of life will also be analyzed, being defined through several validated patient surveys.

"American Medical Systems is pleased to be making the PROPPER registry possible.  We believe this program will play an important role in both clinical development and physician-patient decision making," said Whitney D. Erickson, Senior Vice President, General Manager Men's Health, American Medical Systems.  "PROPPER demonstrates AMS' commitment to assisting patients and healthcare professionals by working closely with urologists to conduct objective and meaningful research."

Results from the PROPPER registry will be published by the researchers, with the initial outcomes expected to be made public in 2013.

About American Medical Systems:

American Medical Systems, headquartered in Minnetonka, Minnesota, is a diversified supplier of medical devices and procedures to cure incontinence, erectile dysfunction, benign prostatic hyperplasia (BPH), pelvic floor prolapse and other pelvic disorders in men and women. These disorders can significantly diminish one's quality of life and profoundly affect social relationships. In recent years, the number of people seeking treatment has increased markedly as a result of longer lives, higher quality-of-life expectations and greater awareness of new treatment alternatives. American Medical Systems' products reduce or eliminate the incapacitating effects of these diseases, often through minimally invasive therapies. The company's products were used to treat more than 340,000 patients in 2010.

More information about the company and its products can be found at www.AmericanMedicalSystems.com and in the Company's Annual Report on Form 10-K for 2010 and its other SEC filings.

SOURCE American Medical Systems