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CE Mark Awarded for Male Urinary Health Device

CE MarkAmerican Medical Systems (AMS) of Minnetonka, Minnesota, announced today it has received the Conformité Européenne (CE) Mark for AdVance XP, an implant for the treatment of male stress urinary incontinence (SUI). The CE marking certifies that a product has met EU health, safety, and environmental requirements, which ensure consumer safety.

Male SUI is a common side effect of prostate cancer and benign prostatic hyperplasia treatments, such as radical prostatectomy and transurethral resection of the prostate.

The company says enhancements in AdVance XP include a redesigned sling that incorporates a new mesh designed to improve procedural reproducibility, longer arms that are easier to use in larger patients and distinct tissue anchors that increase holding power during the critical healing period, following implantation.

AMS anticipates a full-scale launch of the product in Europe by the end of the year. The company has also filed for U.S. Food and Drug Administration clearance.

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