SRS Medical Receives CE Mark for the In-Flow Device
11/6/2002 8:00:00 AM









BILLERICA, Mass., Nov 6, 2002 (BUSINESS WIRE) -- SRS Medical Systems, Inc. today announced it had received certification of CE marking for the In-Flow(TM) device, a urethral stent with a remote-controlled valve-pump mechanism that provides bladder drainage for women who cannot void on their own. (The CE Mark is the symbol used to indicate that a particular product complies with the relevant European regulatory requirements and has achieved a satisfactory level of safety, and thus may be freely marketed throughout the European Community.)

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An estimated 400,000 U.S. women and their counterparts worldwide suffer from atonic bladder, usually as a consequence of spina bifida, multiple sclerosis, stroke, spinal cord injury, etc. In order to void, these individuals must use intermittent or indwelling (Foley) urinary catheters, although their use restricts activity and causes numerous medical problems. There is no cure for atonic bladder, however, the In-Flow device is designed to allow its users to use a toilet again. Unlike catheters, which rely on gravity to passively drain the bladder, the In-Flow device has an advanced turbine pump that spins at 10,000 RPM and actively empties urine.

The In-Flow device was originally developed by Influence Medical Technologies, an Israeli manufacturer, with funding from Medtronic, Johnson & Johnson and others. Key design aspects, including its magnetic activation, are patented worldwide. The In-Flow device has been used by women in Europe and the Pacific Rim since 1997. In the U.S., it is classified as an investigational device and is not currently available for sale, however, clinical trials have been completed and SRS Medical expects to submit a PMA application to the Food and Drug Administration (FDA) shortly.

Now that it has received a CE mark, SRS Medical will reintroduce the In-Flow device in France, Germany, Australia and Canada. In mid-2003, SRS Medical plans to expand its distribution to include Italy, Spain, Korea, Japan and certain other countries in the Pacific Rim. In order to better support prescribing physicians and their patients, SRS Medical is working with MedResources, a Brookline MA consulting firm, to develop a disease management program based on information from successful users worldwide.

SRS Medical Systems, Inc. is a privately held Delaware corporation with facilities in Billerica MA and Redmond WA. For information about SRS Medical and its products, visit http://www.srsmedical.com.

SRS Medical Systems
Jane Stansbury, Product Manager
jstansbury@srsmedical.com
800/345-5642, 425/882-1101
Fax: 425/882-1935


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