AbbeyMoor Medical Inc has received the CE Mark approval for The Spanner Temporary Prostatic Stent for temporary use, 30 days or less in men with bladder outlet obstruction (BOO) to reduce elevated post void residual (PVR) and improve voiding symptoms.
AbbeyMoor Medical plans to launch The Spanner over the next 90 days in a number of European countries, where men suffering BOO are on waiting lists prior to surgery. In addition, The Spanner will be targeted for men experiencing a worsening of voiding symptoms after under going a minimally invasive therapy (MIT) for prostate disease. The company currently plans to launch the product in the United States once FDA approval has been received, anticipated in the second half of next year.
"This is an historic day for our company and for the urologists responsible for the management, assessment and treatment of bladder outlet obstruction in men," said John Reid, Chairman of AbbeyMoor Medical. "We are elated The Spanner is now approved for sale in Europe."
CE Mark approval of The Spanner was issued by the British Standards Institution (BSI). This European regulatory approval was based on a comprehensive review of pre-clinical data, the company's Quality Management System, functional test data, and clinical results.
The Spanner (Patent Pending) is an innovative prostatic stent design that provides ease of insertion and removal, stability in the prostatic urethra and improvements in the wearer's voiding efficiency and symptoms associated with prostatic obstruction.