SRS Medical Receives CE Mark for the In-Flow Device.Business Editors BILLERICA, Mass.--(BUSINESS WIRE)--Nov. 6, 2002 SRS SRS, SRS-A see slow-reacting substance. Medical Systems, Inc. today announced it had received certification of CE marking for the In-Flow(TM) device, a urethral urethral pertaining to or emanating from urethra. urethral agenesis, urethral atresia failure of development of all or part of the urethra: characterized by complete urine retention. A rare cause of neonatal uremia. 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 European Community: see European Union. European Community (EC) Organization formed in 1967 with the merger of the European Economic Community, European Coal and Steel Community, and European Atomic Energy Community. .) An estimated 400,000 U.S. women and their counterparts worldwide suffer from atonic bladder atonic bladder n. A large dilated urinary bladder that does not empty, usually due to disturbance of innervation or to chronic obstruction. , usually as a consequence of spina bifida, multiple sclerosis, stroke, spinal cord injury Spinal Cord Injury Definition Spinal cord injury is damage to the spinal cord that causes loss of sensation and motor control. Description Approximately 10,000 new spinal cord injuries (SCIs) occur each year in the United States. , etc. In order to void, these individuals must use intermittent or indwelling indwelling /in·dwell·ing/ (in´dwel-ing) pertaining to a catheter or other tube left within an organ or body passage for drainage, to maintain patency, or for the administration of drugs or nutrients. (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 PMA (papillary-marginal-attached), n a system of epidemiologic scoring of periodontal disease devised by Schour and Massler in which the symbols denote the areas involved in gingival inflammation. PMA Progressive muscular atrophy application to the Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) 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. |
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