Ethicon, Inc. has announced the availability of the GYNECARE TVT EXACT™ Continence System in the United States. GYNECARE TVT EXACT™ is a new minimally invasive surgical tool used in an outpatient setting for the treatment of stress urinary incontinence (SUI), a condition that affects one in three women in the U.S. The product’s integrated system offers an ergonomically designed handle to improve physician control during surgery.

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American Medical Systems has announced that the U.S. Food and Drug Administration (FDA) has approved the company’s MiniArc Precise single-incision sling system for the treatment of female stress urinary incontinence (SUI). MiniArc Precise is the successor to American Medical’s original MiniArc sling system (launched in 2007), the largest selling single-incision sling in the U.S. having been implanted in more than 75,000 patients.

The European Medicines Agency (EMEA) and the European Commission (EC) have formally designated Tengion Inc.’s Neo-Bladder Augment™ as an Orphan Medicinal Product.  The product has been given this status for the treatment of neurogenic bladder related to spinal cord injury. It had been previously granted this designation for use in the treatment of neurogenic bladder in spinal bifida patients. The new grant provides it regulatory incentives such as eligibility for protocol assistance and reductions in certain fees, along with 10 years of marketing exclusivity in EU. Neurogenic bladder is a critical condition that can cause kidney failure.