Abstract
BackgroundBenign prostatic hyperplasia (BPH) is an affliction of the aging male population that contributes to bothersome and disruptive lower urinary tract symptoms (LUTS). The UroLift® implant has been developed as a mechanical means of widening the prostatic urethra and providing relief from lower urinary tract symptoms (LUTS) through a minimally invasive procedure.MethodsIn the current study, we utilize histological results from canine tissue, resected tissue from human subjects treated with the UroLift System and post-market surveillance data collected by the manufacturer in order to elucidate the long-term biological mechanism of action of the UroLift implant.ResultsThe delivery of the implant causes tissue compression, likely resulting in focal ischemia that causes observed local atrophy and minimal-mild chronic inflammation that ultimately remodels tissue to produce a widened prostatic urethra.ConclusionsThese studies reveal the lack of impact the device has on systemic tissue, providing evidence that the UroLift System is benign and biocompatible, and offering histologic explanation for the clinically observed durability.
Highlights
Implantable medical devices are widely used in the therapeutic management of a broad range of medical conditions
Urinary flow rates improve without reaching levels that are associate with cavitating procedures where most or all prostate glandular tissue is removed
Over 200,000 patients worldwide have been treated with Prostatic Urethral Lift (PUL) conducted with the UroLift System, the first implantable medical device to demonstrate safe and effective improvement of lower urinary tract symptoms (LUTS)/ Benign prostatic hyperplasia (BPH) without the complications associated with permanent prostatic stents
Summary
Implantable medical devices are widely used in the therapeutic management of a broad range of medical conditions. In the US, nearly four million artificial intra-ocular lenses [2], 8000 cochlear implants [3], and 16,000 stent grafts for abdominal aortic aneurysms are implanted into patients each year [4]. These devices serve to reduce risks of mortality, improve quality of life by returning sight and hearing, and avoid the risks of open cavity surgery. The UroLift® implant has been developed as a mechanical means of widening the prostatic urethra and providing relief from lower urinary tract symptoms (LUTS) through a minimally invasive procedure.
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