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SRS Medical Receives CE Mark Approval for Spanner Prostate StentSRS Medical Systems, Inc., today announced that it has received CE mark approval for use of its Spanner® Temporary Prostatic Stent across the European Economic Area (EEA). The Spanner is an alternative to both indwelling (Foley) and intermittent urinary catheters for male patients with bladder outlet obstruction (BOO). This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20160629005808/en/ The Spanner is an alternative to both indwelling (Foley) and intermittent urinary catheters for male patients with bladder outlet obstruction (BOO). (Photo: Business Wire). "The Spanner is proven to have significant impact on medical outcomes, and often has a transformational impact on patient quality of life," said Lee Brody, CEO of SRS Medical. "We are excited to receive this approval, and we look forward to working with our European partners to deliver The Spanner to the ptients that will benefit from it the most." The Spanner is a completely internal device that alleviates BOO while maintaining continence. It allows patients to naturally fill and empty their bladders, often without device awareness. The Spanner has many clinical applications for treating BOO, including:
In the United States, The Spanner is approved by the Food and Drug Administration (FDA) for a single 30-day period in a limited patient population. In January 2016, SRS Medical received FDA investigational device exemption (IDE) approval for a confirmatory safety study to expand the labeling of The Spanner. The CE mark is a result of notified body transfer to Intertek (News - Alert) Semko AB.
About The Spanner Stent
About SRS Medical
View source version on businesswire.com: http://www.businesswire.com/news/home/20160629005808/en/ |