Macroplastique(R) Implantation System
Date: Tue, 22 Feb 2000 17:17:57 EST
Uroplasty, Inc. Receives CE Mark Authorization for Macroplastique(R) Implantation System
MINNEAPOLIS, Feb. 22 /PRNewswire/ — Uroplasty, Inc. (OTC Bulletin Board: UROP.OB) and its European subsidiaries have recently received notification that they have successfully demonstrated compliance with the Medical Devices Directive 93/42/EEC for a newly developed set of instruments for the non-endoscopic delivery of Macroplastique(R) named the Macroplastique Implantation System (MIS). Uroplasty is therefore authorized to use the CE mark on the MIS. CE mark authorization entitles the Company to market and
sell the MIS throughout the European Community countries. Uroplasty has also obtained proper approval to market and sell the MIS in Canada, and believes that similar approvals in other countries where its products are being sold will be readily obtainable when needed.
The Macroplastique Implantation System is a simple yet technically designed instrument intended for use by urologists, gynecologists, and uro-gynecologists to deliver Macroplastique Implants for the minimally invasive treatment of female stress urinary incontinence (SUI). The novel and patented design of the MIS provides for implantation of the Company’s soft tissue bulking material into the wall of the urethra without the use of an endoscope. The Company believes that the MIS will make Macroplastique available %