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Other products discussed in this article include a prosthesis for underactive bladder, a prostate cancer test, and an erectile dysfunction drug.
San Diego-Imprimis Pharmaceuticals, Inc. has entered into a license agreement in which it has acquired the U.S. rights to commercially compound a patented combination of alkalized lidocaine and heparin from Urigen Pharmaceuticals, Inc. The compounded drug formulation has been used to treat patients with interstitial cystitis/painful bladder syndrome. Compounded alkalized lidocaine and heparin instillation procedures have been reimbursable under CPT code 51700. The license is for the U.S. market only and covers certain U.S. patent rights that extend through 2026. Imprimis said it will build a dedicated national education and awareness program called Defeat IC, which the company expects to launch in early 2015.
For more information, visit www.ImprimisPharma.com.
Redmond, WA-Vesiflo, Inc. said its direct de novo petition for the inFlow Urinary Prosthesis has been granted by the FDA, allowing the device to be marketed in the United States. The inFlow, a replaceable intraurethral valve pump in a silicone housing, is an alternative to urinary catheters in women with impaired detrusor contractility. The inserted device resides almost entirely in the urethra. To void, the user sits on a toilet, holds a remote control over the lower pelvic area, and presses a button. This magnetically activates the miniature internal pump, which drains the bladder at a normal flow rate.
For more information, visit www.vesiflo.com.
Cambridge, MA-Metamark announced nationwide availability of ProMark, a protein-based biopsy test designed to improve the accuracy of prognosis for men diagnosed with prostate cancer. In men with indeterminate Gleason scores (3+3 and 3+4), ProMark can help identify aggressiveness of the disease, according to the company. ProMark measures the amount of specific protein biomarkers obtained by needle biopsy from regions of prostate tissue where the biomarkers are altered during tumor formation. The molecular data that determine prognosis can be measured at a very early stage of the disease with ProMark, before key treatment choices must be made, Metamark said.
For more information, visit www.metamark.us.
Westborough, MA-United Medical Systems, Inc. unveiled a new initiative to partner with physicians and expand its business model for providing sophisticated, transportable equipment and highly trained personnel for urologic and other procedures. The initiative is aimed at helping physicians reduce costly overhead expenses for servicing and managing outdated or underutilized equipment while gaining access to effective technical staff, according to the company. With the support of private investor New State Capital Partners, United Medical will expand its partnerships with underserved physicians by either buying their old equipment and providing access to modern equipment, providing technicians, or both-depending on physicians’ needs.
For more information, visit www.ums-usa.com.
Dublin, OH-The FDA has approved Navidea Biopharmaceuticals’ supplemental new drug application for the expanded use of technetium Tc 99m tilmanocept (Lymphoseek) injection for lymphatic mapping in solid tumors. The agent is now indicated for lymphatic mapping using a handheld gamma counter to locate lymph nodes draining a primary tumor site in patients with solid tumors for which this procedure is a component of intraoperative management, according to the company. The FDA also allowed expanded utilization of Lymphoseek with or without scintigraphic imaging to enable preoperative imaging and mapping of lymph nodes to facilitate node localization during surgical procedures.
For more information, visit www.navidea.com.
Minneapolis-Medtronic’s FDA-approved Verify Evaluation System is used temporarily to determine if the company’s InterStim System may provide long-term relief for a patient suffering from chronic symptoms of overactive bladder, non-obstructive urinary retention, or bowel incontinence. While an evaluation system has been available previously, the Verify System offers a more discreet and unobtrusive experience to patients during the evaluation period, according to Medtronic.
For more information, visit www.medtronic.com.
Muskegon, MI-StomaCloak ostomy pouch and bag covers from MED 5 LLC significantly reduce human waste odor associated with ostomy procedures. Covers are made of proprietary polyester material impregnated with carbon, zeolite, and antimicrobials to reduce odors. Designed by a urologist, the covers are latex free and have a custom-sized ring for a secure fit for one- and two-piece ostomy appliances. They fit over Hollister, CovaTec, Coloplast, Nu-Hope, and other collection bags.
For more information, visit www.stomacloak.com.
Schaumburg, IL-Sagent Pharmaceuticals, Inc.’s lidocaine HCL jelly USP, 2% (GLYDO) is a topical urologic anesthetic lubricant available in prefilled, ready-to-use, disposable plastic syringes in two sizes: 6 mL and 11 mL. Syringes are packaged individually to allow the product to be used during surgical procedures and maintain the integrity of the sterile field. GLYDO is indicated for prevention and control of pain in procedures involving the male and female urethra, for topical treatment of painful urethritis, and as an anesthetic lubricant for endotracheal intubation.
For more information, visit www.sagentpharma.com.
Mountain View, CA and Chesterbrook, PA-VIVUS and Auxilium Pharmaceuticals announced that the FDA approved a supplemental new drug application for avanafil (Stendra), which is now approved to be taken as early as 15 minutes before sexual activity. An oral phosphodiesterase-type-5 inhibitor, it is available in dosage strengths of 50, 100, and 200 mg and may be taken with or without food and moderate alcohol consumption.
For more information, visit www.STENDRA.com.
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