Studies show effectiveness, safety of laser PVP for prostate treatment

May 22, 2008 -- American Medical Systems, Inc. (AMS) presented a range of studies on its GreenLight laser system at the 2008 annual meeting of the American Urological Society (AUA), which is taking place this week in Orlando. Among the 20 abstracts presented, two were randomized studies, conducted by international teams of researchers, concluding that Photoselective Vaporization of the Prostate (PVP) performed with the GreenLight laser is safer than, and as effective as, the invasive Transurethral Resection of the Prostate (TURP) procedure, which is the most common type of surgery for Benign Prostatic Hyperplasia (BPH).

"These studies support AMS' belief that GreenLight is the best treatment for men suffering from BPH," said Ross Longhini, Chief Operating Officer at American Medical Systems. "For nearly 10 years, medical researchers from around the world have exhaustively examined the usage, indications, outcomes and safety of the GreenLight system. The clinical papers presented at AUA provide perhaps the most compelling set of evidence yet for the efficacy and safety of the GreenLight PV and GreenLight High Performance System (HPS) for a wide range of patients."

In addition to the randomized studies, research data presented included:
-- Findings that GreenLight laser therapy is safe, effective and durable out to 5 years for the treatment of men with BPH
-- Studies demonstrating that GreenLight HPS is significantly faster than the GreenLight PV system, but is just as safe and effective
-- Evidence that GreenLight HPS quickly and safely treats patients with prostate glands over 80g
-- Additional evidence that GreenLight may be the most safe and effective treatment for BPH in most patients

GreenLight laser therapy, with over 300,000 procedures performed worldwide, has become a favored alternative to TURP due to it being a minimally invasive outpatient procedure, its high tissue removal efficiency, quick recovery time, and rapid flow rate improvement with minimal side effects. The patented 532nm wavelength laser provides efficient vaporization of prostatic tissue, due to the wavelength's high absorption in oxyhemoglobin, and low absorption in water - ensuring laser energy is not lost in the procedural irrigation medium.

GreenLight HPS is a newer version of its predecessor, the GreenLight PV system that removes tissue more rapidly resulting in shorter procedure times and the ability to treat larger glands more efficiently. The physical properties of HPS yield safety and efficacy outcomes consistent with GreenLight PV.

Of the 20 GreenLight PVP studies presented at AUA 2008, 17 were independently conducted whereas three were funded through AMS research grants. Titles and authors include:

-- "80W PVP versus TURP: results of a randomized prospective study at 12 months of follow-up" (Skolarikos A, Alivizatos G, Chalikopoulos D, Papachristou C, Varkarakis IM, Chrisofos M, Kastriotis I, Deliveliotis C)

-- "A randomised trial of photoselective vaporization of the prostate (PVP) using the GreenLight laser versus transurethral prostatectomy (TURP) with one year follow-up" (Bouchier-Hayes D, Van Appledorn S, O'Malley PJ, Bugeja P, Costello AJ)

-- "Comparison of vaporization efficiency of the 80W potassium-titanyl-phosphate (KTP) GreenLight laser and the 120W GreenLight high performance system (HPS) laser for photoselective vaporization of the prostate" (Schwartz MJ, Wysock JS, Wang GJ, Lee RK, Kim RY, Tabatabaei S)

-- "Photoselective vaporization of the prostate first 5 years follow-up study" (MA Hai)

-- "Comparative evaluation of high power 532nm laser systems, 120 watt (HPS) vs. 80 watt (KTP), for photoselective vaporization of the prostate (PVP) of large glands with vaporization incision technique (VIT)" (Zoltan E, Lee RK, Saini R, Egan CA, Kaplan SA, Te AE)

-- "International multicenter experience of the GreenLight HPS 120W laser in patients with benign prostatic obstruction" (Tabatabaei S, Reich OM, de la Rosette J, Collins EJ, Bachmann A, Choi BB, Muir GH, Gomez Sancha F, Woo HH)

-- "One and two year pressure-flow/uro-dynamic results of photoselective vaporization of prostate using local anaesthesia with light sedation" (Arum CJ, Romundstad PR, Mjones J)

-- "Efficiency of lithium triboride (LBO) laser photoselective vaporization prostatectomy (PVP): kinetic performance study" (Wong C, Spaliviero M, Culkin DJ)

-- "A randomized, placebo-controlled, double-blind
study of the use of dutasteride for improving operative outcomes of photoselective vaporization of the prostate (DOP trial)" (Bepple JL, Barone B, Eure G)

-- "Measurement of the power output during photoselective vaporisation of the prostate with the 80W-KTP-GreenLight laser. Need for better quality laser fibres" (Hermanns T, Sulser T, Baumgartner MK, Fatzer M, Sigrist MW, Seifert H)

-- "Does lithium triboride (LBO) laser photoselective vaporization prostatectomy (PVP) affect sexual function?" (Araki M, Spaliviero M, Wong C)

-- "Catheter free lithium triboride (LBO) laser photoselective vaporization prostatectomy (PVP)" (Spaliviero M, Araki M, Wong C)

-- "Lithium triboride (LBO) laser photoselective vaporization prostatectomy (PVP) for symptomatic benign prostatic hyperplasia (BPH): initial outcomes" (Wong C, Spaliviero M, Araki M)

-- "Lithium triboride (LBO) laser photoselective vaporization prostatectomy (PVP) for large volume benign prostatic hyperplasia (BPH)" (Spaliviero M, Araki M, Wong C)

-- "Photoselective vaporization of the prostate for the treatment of benign prostatic hyperplasia: initial experience in 250 Japanese patients" (Kuwahara Y, Horiba M, Otsuki H, Nagakubo I)

-- "Impact of hemoglobin levels on the efficiency of GreenLight laser (CTP 80W) vaporization of the prostate" (Buse S, Gilfrich C, Hatiboglu G, Huber J, Pfitzenmaier J, Haferkamp A, Hohenfellner M)

-- "Clinical evaluation on sexual function of BPH patients after photoselective vaporization of the prostate" (Shan XY)

-- "International multicenter experience of the GreenLight HPS 120W laser in patients with benign prostatic obstruction, in urinary retention, on anticoagulants and with large prostates" (Woo HH, Reich OM, de la Rosette J, Collins EJ, Bachmann A, Choi B, Muir GH, Gomez Sancha F, Tabatabaei S)

-- "Octogenarians with symptomatic benign prostatic hyperplasia (BPH) have similar outcomes after photoselelctive laser vaporization of the prostate(PVP) compared to a younger cohort despite increased comorbidities" (Gonzalez RR, Soni SD, Reddy B, Madhu M, Kaplan SA, Te AE)

-- "High-power potassium-titanyl-phosphate (KTP/532) laser vaporization prostatectomy: 4 years later" (Ruszat R, Wyler s, Rieken M, Abe C, Gasser T, Bachmann, A)

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