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U.S. Department of Health and Human Services

Product Classification

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Device implantable transprostatic tissue retractor system
Definition The treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (bph) in men age 50 and above.
Physical State Comprises two main components, the delivery device and implant. Each delivery device comes pre-loaded with one I\implant. The delivery device is inserted into a 20F cystoscopy sheath which has been placed in the male urethra with the sheath tip located within the bladder. After insertion into the sheath, the tip of the device is positioned in the prostatic urethra and used to retract an obstructing prostatic lobe. An implant is then deployed transversely through the urethra into the prostatic tissue. The implant is secured to maintain the retracted position of the lobe. Implants are deployed thereby maintaining an expanded urethral lumen.
Technical Method Delivered transurethrally using a rigid delivery device which is used to displace the urethra towards the prostatic capsule. The implants then maintain the approximated position of the inner (urethral) tissue and the outer (capsular) tissue of the prostate thereby reducing fluid obstruction and improving LUTS. The displaced urethra then provides increased urethral opening. The biological mechanism of action is localized transient tissue compression leading to lobular atrophy. Once lobular atrophy has been obtained, the static implant imparts no further mechanical stimulation on the tissue, and tissue remodeling is complete.
Target Area Prostate
Regulation Medical Specialty Gastroenterology/Urology
Review Panel Gastroenterology/Urology
Product CodePEW
Premarket Review Office of Device Evaluation (ODE)
Division of Reproductive, Gastro-Renal, and Urological Devices (DRGUD)
Urology and Lithotripsy Devices Branch (ULDB)
Submission Type 510(k)
Regulation Number 876.5530
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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