Results from Large Randomized Trial Support Use of Innovative 180 Watt Laser Therapy as a Viable Treatment Option for More Than 110 Million Men Worldwide with Enlarged Prostate
MINNETONKA, Minn.--(BUSINESS WIRE)-- Data presented at the American Urological Association (AUA) Annual Meeting demonstrate that treatment for Benign Prostatic Hyperplasia (BPH) with GreenLight XPS(R) laser therapy with MoXy(R) fiber, instead of transurethral resection of the prostate (TURP), results in significantly shorter hospitalization, catheterization, and recovery times for patients, while maintaining equivalent safety and efficacy.
"This trial provides important new information that may cause many urologists and patients to choose GreenLightTM laser therapy as an alternative to TURP, which has long been regarded as the standard surgical treatment for BPH," said Professor Alexander Bachmann, M.D., University Hospital Basel, Switzerland, and principal investigator in the GOLIATH study. "With faster recovery times, less time spent in the hospital and less catheterization time than TURP, GreenLightTM is a highly effective therapy for the treatment of BPH."
The findings from the prospective, multicenter, randomized GOLIATH trial, demonstrate the equivalence in safety and effectiveness of the 180W GreenLight XPS(R) system for addressing lower urinary tract symptoms associated with BPH. Manufactured by American Medical Systems, an Endo Health Solutions Inc. (Nasdaq: ENDP) subsidiary, GreenLight XPS(R) is the most widely used BPH laser treatment currently on the market.
"GreenLightTM laser therapy is the leading minimally invasive laser surgical treatment for BPH world-wide, and offers patients a proven innovative option to TURP," said Camille Farhat, president of AMS. "Left untreated, BPH, and the resulting symptoms, can cause permanent damage to the urinary system. We look forward to helping more men who undergo surgery for BPH recover faster and potentially return to their active lifestyles more quickly."
During the GreenLightTM procedure, the physician uses a laser to remove excess prostate tissue, creating a larger channel for urine flow to pass through. The innovative, outpatient procedure is suitable for most patients with enlarged prostates, delivers rapid urine flow improvement, and provides immediate and lasting relief of lower urinary tract symptoms. GreenLightTM is available in 70 countries has been used to treat more than 700,000 patients worldwide. More information is available for physicians at www.amsgreenlight.com and for patients at www.greenlightforbph.com.
GOLIATH Study Trial Design and Results
The GOLIATH study was designed to compare TURP and PVP (Photo-Selective Vaporization of the Prostate) with the 180W GreenLight XPS(R) system using a variety of symptomatic, functional and safety outcome measures. The study evaluated 269 patients from 29 sites in 11 European countries based on 6-month post procedural results. All adverse events were adjudicated and classified by an independent, blinded clinical events committee.
Key trial findings include:
-- Equivalency in safety, as evidenced by the number and rate of adverse
events, and efficacy, as determined by IPSS (International Prostate
Symptom Score) and Qmax (peak urinary flow rate)
-- Superiority of GreenLight XPS(R) in recovery times including shorter
catheterization times, shorter hospital stay, and a faster return to a
stable health status
-- Significantly lower rate of short-term re-intervention with GreenLight
-- Numerically fewer bleeding and dysuric events with GreenLight XPS(R)
-- Comparable prostate tissue volume and PSA (prostate specific antigen)
reduction About BPH
More than 110 million men globally suffer from BPH,1 a condition in which an enlarged prostate presses on the urethra, which can obstruct the flow of urine and cause problems such as frequent urination, pain or burning while urinating, and weak urine flow. If left untreated, BPH can lead to such issues as kidney damage,2 severe urinary tract infections,3 visible blood in the urine,4
chronic renal failure.5 According to the AUA, by 60 years of age, BPH prevalence is greater than 50 percent and by age 85 is as high as 90 percent. BPH is so common it has been said that all men will have an enlarged prostate if they live long enough.6
About GreenLight XPS(R)
The GreenLight(TM) laser system is intended for incision/excision, vaporization, ablation, hemostasis and coagulation of soft tissue, including photoselective vaporization of the prostate for benign prostatic hyperplasia (BPH). The laser system is contraindicated for patients who: are contraindicated for surgery, contraindicated where appropriate anesthesia is contraindicated by patient history, have calcified tissue, require hemostasis in >2mm vessels, have uncontrolled bleeding disorders, have prostate cancer, have acute urinary tract infection (UTI) or severe urethral stricture. Possible risks and complications that include, but are not limited to, irritative symptoms (dysuria, urgency, frequency), retrograde ejaculation, urinary incontinence, erectile dysfunction, hematuria - gross, UTI, bladder neck contracture/outlet obstruct, urinary retention, perforation - prostate, urethral stricture.
About American Medical Systems
American Medical Systems (AMS), headquartered in Minnetonka, Minn., is a diversified supplier of medical devices and procedures to treat incontinence, erectile dysfunction, benign prostatic hyperplasia (BPH), pelvic floor prolapse 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. AMS is an operating company of Endo Health Solutions Inc. (Nasdaq: ENDP), 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 (AMS ppt: Benign Prostatic Hyperplasia, Understanding Market Size and Patient Flow: An Analysis of Census Data and Available Literature 2010)
2 Carter HB. Prostate Disorders: The Johns Hopkins White Papers. Baltimore, MD: Johns Hopkins Medicine; 2010:1-24.
3 Urinary tract infections. US National Library of Medicine, National Institute of Health. http://www.nlm.nih.gov/medlineplus/ency/article/000521.htm. Accessed Oct. 27, 2010.
4 Enlarged prostate. US National Library of Medicine, National Institute of Health. http://www.nlm.nih.gov/medlineplus/ency/article/000381.htm. Accessed Sept. 27, 2010.
5 Aging changes in the male reproductive system: MedlinePlus Medical Encyclopedia. National Institutes of Health. http://www.nlm.nih.gov/medlineplus/ency/article/004017.htm. Accessed Nov 22, 2011.
6 Enlarged prostate. US National Library of Medicine, National Institute of Health. http://www.nlm.nih.gov/medlineplus/ency/article/000381.htm. Accessed Sept. 27, 2010.
American Medical Systems Investors/Media: Blaine Davis (484) 216-7158 or Media: Brian O'Donnell (484) 216-6726 or Investors: Jonathan Neely (484) 216-6645
Source: American Medical Systems
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