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New Products & Services
Alpha-blocker safe, effective in managing BPH symptoms
Corona, CA-Watson Pharmaceuticals has announced FDA approval of the alpha-blocker silodosin (RAPAFLO) for treatment of the signs and symptoms of BPH. Approval was predicated on data from two phase III, randomized, double-blind, placebo-controlled studies of 923 men. After 12 weeks, those who received silodosin, 8 mg once daily, demonstrated significant relief of BPH symptoms compared with placebo, using the International Prostate Symptom Score (mean reduction of –6.4 points vs. –3.5 points, respectively, p<.0001). Qmax improved as quickly as 2 hours after the first dose (p<.0001). A 40-week, open-label study in 661 men reported drug-related adverse events in 28.4%, but no significant changes in blood pressure or meaningful prolongation of the QT interval.
For more information, visit http://www.watson.com/.
Raynham, MA-Mpathy Medical's Restorelle Y is a surgeon-developed solution for vaginal vault prolapse repair using an abdominal, laparoscopic, or robotic approach. It uses physiologically compatible Smartmesh, which weighs 19 grams/square meter and conforms to the vault shape for easy placement and draping during fixation. Its 1.8-mm pores make the graft nearly transparent during laparoscopic surgery and enable suture passage through the mesh without needles. In one series, Smartmesh showed a 99% cure rate and no de novo dyspareunia; another series showed one vaginal mesh erosion in 360 mesh implants.
For information, visit http://www.mpathymedical.com/.
New fiber expands laser Tx to multiple urologic conditions
Minnetonka, MN-American Medical Systems' new GreenLight High Performance System (HPS) Extended Applications (EA) fiber is designed to extend the capabilities of the system beyond treatment of BPH to treatment of other urologic conditions, such as ureteral strictures and bladder tumors, on an outpatient basis. The new laser fiber features optimal energy output and precise depth of penetration to minimize collateral tissue injury. The fibers can be inserted through a scope smaller than that used for traditional surgeries to minimize patient discomfort.
For more information, visit http://www.AmericanMedicalSystems.com/.
Subcutaneous drug relieves hypogonadism symptoms
Durham, NC-Slate Pharmaceuticals' Testopel pellets are FDA-approved for use as hormone replacement therapy in men with deficient or absent endo-genous testosterone manifested as congenital or acquired primary or hypogonadotrophic hypogonadism. Implanted subcutaneously in an office-based procedure at dosages of 150 mg to 450 mg, the pellets release a measured dose of hormone over a 3- to 6-month period. Side effects may include gynecomastia, risk of prostatic hypertrophy or carcinoma, edema, and liver diseases. The product is contraindicated in men with breast or prostate cancers.
For information, visit http://www.slatepharma.com/.
Surgical shields ensure sterility of OR instrument trays
For more information, visit http://www.spectrumsurgical.com/.