American Medical Systems Announces 500th Patient Enrolled in PROPPER Registry
Largest Prospective, Multi-Year, Physician-Led Registry Advances Understanding of Real-World Satisfaction with Penile Prostheses
MINNEAPOLIS, Nov. 19, 2013 /PRNewswire/ — American Medical Systems(®) (AMS), Inc. an Endo Health Solutions Inc. (Nasdaq: ENDP) subsidiary and leading provider of devices and therapies for male and female pelvic health, today announced the enrollment of the 500th patient in the largest multi-year, prospective global registry study of penile prosthetic outcomes in the world.
The study, entitled PROPPER (Prospective Registry of Outcomes with Penile Prosthesis for Erectile Restoration), is sponsored by AMS and is being conducted by a team of experienced urologists at 14 North American sites. It aims to better characterize real-world patient satisfaction and other outcomes such as device effectiveness and durability among men who are receiving these prosthetic solutions to treat their erectile dysfunction (ED).
Initial results for the first 50 patients implanted with AMS 700 inflatable penile prostheses were presented by Dr. Edward Karpman, El Camino Urology Medical Group, Mountain View, CA, at the 2013 American Urological Association (AUA) Annual Meeting in May. “PROPPER is the first-of-its kind observational registry that captures critical data about real-life outcomes to aid patients and their doctors in making important decisions about their ED treatment options,” said Karpman. “This is an ongoing process, and we expect the database to continue growing as more men, with the support of their partners, consider penile implants.”
Additional data from the PROPPER study will be presented at upcoming medical meetings, including sectional meetings of the AUA and the Sexual Medicine Society of North America (SMSNA) Fall Scientific Meeting. The 14 physician investigators are expected to enroll up to 1,000 men diagnosed with erectile dysfunction (ED) in this registry, and follow up with these patients at regular intervals over 5 years. “We are pleased to be able to partner with these physician investigators in PROPPER and add to the clinical understanding about the safety and performance of our devices in real-life outcomes. While we already have the most number of patients already enrolled in a prospective, multi-year, multi-center, global registry, we intend to continue enrolling patients for the foreseeable future” said Dr. Ronald Morton, Chief Surgical Officer, AMS.
In a variety of clinical studies, the percentage of patients moderately satisfied to very satisfied with penile implants ranged from 75-98%.(1-6) Furthermore, in a study of 200 patients and 120 partners, 92 percent of patients and 96 percent of their partners reported excellent or satisfactory sexual activity.(4)
“American Medical Systems, an established world-leader in treatments for ED and other pelvic health disorders, is committed to advancing the treatment of ED, to give men and their partners highly effective, world-class treatment options,” said Dev Kurdikar, Senior Vice President and General Manager, Men’s Health, American Medical Systems. “We’re very pleased to reach this milestone in the PROPPER registry, as we believe strongly that collecting this data to confirm the benefits of our products is critical to future product development.”
For more information about American Medical Systems solutions for ED, visit www.EDcure.org.
About Erectile Dysfunction
About 1 in 5 American men over the age of 20 experience some degree of ED(8), adding up to an estimated 30 million men.( 9) For many patients, drugs and other therapies are not a satisfying option with treatment discontinuation rates of up to 60%.(10-12)Penile implants, first invented and developed at AMS, have helped more than 300,000 men return to an active and satisfying sex life(13) over the past 40 years.(14)
About the AMS 700((TM)) Series Inflatable Penile Prosthesis Product Line
The AMS 700((TM)) Series Inflatable Penile Prosthesis product line is intended for use in the treatment of chronic, organic, male erectile dysfunction (impotence). These devices are contraindicated in patients who have active urogenital infections or active skin infections in the region of surgery or for the AMS 700((TM)) with Inhibizone((TM)) have a known sensitivity or allergy to rifampin, minocycline, or other tetracyclines. Implantation will make latent natural or spontaneous erections, as well as other interventional treatment options, impossible. Men with diabetes, spinal cord injuries or open sores may have an increased risk of infection, which may lead to device explantation or revision surgery.
About American Medical Systems
American Medical Systems (AMS), headquartered in Minnetonka, Minn., is a diversified supplier of medical devices and procedures to treat benign prostatic hyperplasia (BPH), incontinence, sexual dysfunction, and other pelvic disorders in men and women. AMS continues to develop new therapies to restore bodily functions and to enable people to regain control of their lives. These therapies provide new options for patients, providers and payers, and are often inspired by the urologists, gynecologists and urogynecologists who choose AMS as their solutions partner. AMS is part of Endo, a diversified healthcare company that is dedicated to improving care through a combination of branded products, generics, devices, technology and services. Learn more at www.endo.com.
Safe Harbor Statement
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements including words such as “believes,” “expects,” “anticipates,” “intends,” “estimates,” “plan,” “will,” “may,” “look forward,” “intend,” “guidance,” “future” or similar expressions are forward-looking statements. Because these statements reflect our current views, expectations and beliefs concerning future events, these forward-looking statements involve risks and uncertainties. Investors should note that many factors, as more fully described under the caption “Risk Factors” in Endo Health Solutions’ Form 10-K, Form 10-Q and Form 8-K filings with the Securities and Exchange Commission and as otherwise enumerated herein or therein, could affect our future financial results and could cause our actual results to differ materially from those expressed in forward-looking statements contained in the Endo Health Solutions Annual Report on Form 10-K. The forward-looking statements in this press release are qualified by these risk factors. These are factors that, individually or in the aggregate, could cause our actual results to differ materially from expected and historical results. We assume no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.
1. Rajpurkar A, Dhabuwala CB. Comparison of satisfaction rates and erectile function in patients treated with sildenafil, intracavernous prostaglandin E1 and penile implant surgery for erectile fysfunctions in urology practice.. J Urol. 2003;170:159-163.
2. Levine LA, Estrada CR, Morgantaler A. Mechanical reliability and safety of, and patient satisfaction with the Ambicor inflatable penile prosthesis: results of a 2 center study. J Urol. 2001; 166(3); 932-937.
3. Lux M, Reyes-Vallejo L, Morgentaler A, et al. Outcomes and satisfaction rates for the redesigned 2-piece penile prosthesis. J Urol. 2007;177(1):262-266.
4. Montorsi F, Rigatti P, Carmignani G, et al. AMS three-piece inflatable implants for erectile dysfunction: a long-term multi-institutional study in 200 consecutive patients. Eur Urol. 2000;37(1):50-55.
5. Natali A, Olianas R, Fisch M. Penile implantation in Europe: successes and complications with 253 implants in Italy and Germany. J Sex Med. 2008;5(6):1503-1512.
6. Ferguson KH, Cespedes RD. Prospective long-term results and quality-of-life assessment after Dura-II penile prosthesis placement. Urology. 2003;61(2);437-441.
7. Hellstrom WJ, Montague DK, Moncada I, et al. Implants, mechanical devices, and vascular surgery for erectile dysfunction. J Sex Med. 2010;7(1 Pt 2):501-523.
8. Selvin E, Burnett A, Platz E. Prevalence and risk factors for erectile dysfunction in the U.S. Am J Med. 2007;(120):151-157
9. Erectile dysfunction. http://kidney.niddk.nih.gov/KUDiseases/pubs/ED/ErectileDysfunction_508.pdf. National Kidney and Urologic Diseases Information Clearinghouse Web site. Downloaded January 21, 2013.
10. VIAGRA(®) Prescribing Information. Pfizer Inc. Revised January 2010:8-9.
11. CIALIS(®) Prescribing Information. Lilly USA, LLC. Revised 2011:18-20.
12. LEVITRA(®) Prescribing Information. Bayer HealthCare Pharmaceuticals Inc. 2011:19-20.
13. Penile prosthesis. http://www.essm.org/society/esha/malesd/oraltreatments/penileprosthesis.html.European Society for Sexual Medicine (ESSM) Web site. Downloaded January 1, 2013.
14. Scott FB, Bradley WE, Timm GW. Management of erectile impotence: use of implantable inflatable prosthesis. Urology. 1973;2(1):80-82.
SOURCE American Medical Systems