The Spanner™ Prostatic Stent is designed to hold open an obstructed prostatic urethra to help patients maintain urine flow and permit volitional voiding by reducing urethral resistance within the prostate. FDA and CE Mark approved for men with BPH, enlarged prostate, suspected bladder problems, urination problems, or similar urology symptoms.
History of Prostatic Stenting
In ancient Greece, urination problems were treated with catheters (tubes) made of bronze. (300 BC). In modern times, the Foley Catheter has been the standard of care for men who cannot urinate. Prostatic stents have been designed to provide an improvement from Foleys for some patients by allowing volitional voiding without external paraphernalia.
References
Fast Facts
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Introduced in
2003 worldwide, 2006 in USA
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Developed by
AbbeyMoor Medical, Inc.
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Certifications
FDA approved, CE Mark
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FDA Indication for Use
The Spanner™ Temporary Prostatic Stent is intended for temporary use (up to 30 days) to maintain urine flow and allow voluntary urination in patients following minimally invasive treatment for benign prostatic hyperplasia (BPH) and after initial post-treatment catheterization.
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CE Mark Indication for Use
The Spanner is indicated for temporary use (up to 90 days) in men with bladder outlet obstruction (BOO) to reduce elevated post void residual (PVR) and improve voiding symptoms.
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Quality Manufacturing Info
AbbeyMoor Medical’s Quality System is in accordance with Good Manufacturing Practices (GMP) per Quality System Regulations (QSR) 21 CFR Part 820, ISO 13485:2003, and Council Directive 93/42/EEC, Annex II.
