The prosthesis utilizes natural-feeling dual-layer silicone and includes a Nitinol core to optimize comfort, rigidity, and durability for effective penetration and concealment, according to Boston Scientific.
Penile prosthesis offers durability, natural feel
Boston Scientific recently launched the Tactra Malleable Penile Prosthesis in the U.S. for the treatment of erectile dysfunction. Approved by the FDA earlier this year, the prosthesis utilizes natural-feeling dual-layer silicone and includes a Nitinol core to optimize comfort, rigidity, and durability for effective penetration and concealment, the company says. The implant is manually lifted up for intercourse and manually pushed down when not in use. New design features of the Tactra Penile Prosthesis allow physicians to provide patients unable to take oral medications or who are ineligible/uninterested in an inflatable penile prosthesis with a device to help restore their sexual function with excellent rigidity and dependable concealment in a device that is easy to use and natural to the touch, according to Boston Scientific.
For more information, visit www.bostonscientific.com.
Next: Enteric-coated formulation of cystinuria Tx approved
Enteric-coated formulation of cystinuria Tx approved
Retrophin, Inc. recently announced the FDA approval of 100-mg and 300-mg tablets of tiopronin (THIOLA EC), a new enteric-coated formulation of tiopronin (THIOLA) to be used for the treatment of cystinuria. The recommended initial dosage of tiopronin in adult patients is 800 mg per day, and in clinical studies the average dose of tiopronin was approximately 1,000 mg, or 10 pills per day, according to the company. The original formulation of THIOLA 100 mg is recommended to be administered at least one hour before or two hours after meals. THIOLA EC 100-mg and 300-mg tablets are recommended to be administered with or without food. THIOLA EC tablets were approved through the 505(b)(2) regulatory pathway, which allows the FDA to reference previous findings of safety and efficacy for an already-approved product, combined with reviewing findings from further studies of the product.
For more information, visit www.retrophin.com.
FDA approves new combination antibacterial for UTI
The FDA has approved imipenem, cilastatin, and relebactam (RECARBRIO) for injection, 1.25 grams, a new combination antibacterial. The treatment is indicated in patients 18 years of age and older who have limited or no alternative treatment options for the treatment of complicated urinary tract infections, including pyelonephritis, caused by the following susceptible Gram-negative microorganisms: Enterobacter cloacae, Escherichia coli, Klebsiella aerogenes, Klebsiella pneumoniae, and Pseudomonas aeruginosa.
For more information, visit www.merck.com.
Urologist-hosted podcast focuses on men’s health
“The Original Guide to Men’s Health” is a podcast hosted by urologist Richard S. Pelman, MD. It consists of 25- to 60-minute episodes that serve as a gateway and resource for men of all ages to learn what they should know about their biology and health, how and when to access the health care system, and what they can do to achieve and manage good physical, mental, and reproductive health. Notable episodes include “Testosterone–Myths, Facts, and Everything in-Between;” “BPH– Three Letters that Impact Every Guy;” and “Understanding and Navigating the Health Insurance System.”
For more information, visit bit.ly/menshealthpod.