Medical policy: Permanently Implanted Prostatic Devices for Benign Prostatic Hyperplasia

Número de política: MP 4.055

Fecha de entrada en vigor: 11/1/2026

Política

The use of permanently implanted prostatic stent devices (e.g., ProVee System, Zenflow Spring Implant) is considered investigational as a treatment of lower urinary tract symptoms due to benign prostatic hyperplasia. No hay pruebas suficientes para apoyar una conclusión general con respecto a los resultados o beneficios para la salud asociados con este procedimiento.

Referencias cruzadas

• MP 1.164 Temporarily Implanted Nitinol Device (iTind) for Benign Prostate Hyperplasia
• MP 4.051 Prostate Artery Embolization
• MP 4.053 Transurethral Water Vapor Thermal Therapy and Transurethral Water Jet Ablation (Aquablation) for Benign Prostatic Hypertrophy

Variaciones del producto

Esta política solo se aplica a ciertos programas y productos administrados por Capital Blue Cross y está sujeta a variaciones en los beneficios. Consulte la información adicional a continuación.

FEP PPO - Refer to Section VI of the FEP Medical Policy Manual. The FEP Medical Policy Manual can be found at: FEP Medical Policy Manual.

Descripción/Antecedentes

Benign prostatic hyperplasia

La hiperplasia prostática benigna (BPH) es un trastorno común entre las personas mayores que es provocado por nódulos hiperplásicos en la zona periuretral o transicional de la próstata. Las manifestaciones clínicas de la BPH incluyen aumento de la frecuencia urinaria, nicturia, urgencia o dificultad para orinar y flujo urinario débil. Los síntomas del tracto urinario a menudo progresan con un empeoramiento de la hipertrofia y pueden conducir a retención urinaria aguda, incontinencia, insuficiencia renal y/o infección del tracto urinario. Benign prostatic hyperplasia prevalence increases with age and is present in more than 50% of individuals in their 60s, rising to 90% in their 90s.

Two scores are widely used to evaluate BPH-related symptoms: the American Urological Association Symptom Index (AUASI) and the International Prostate Symptom Score (IPSS). The AUASI is a self-administered 7-item questionnaire assessing the severity of various urinary symptoms. Total AUASI scores range from 0 to 35, with overall severity categorized as mild (≤7), moderate (8-19), or severe (20-35). The IPSS incorporates questions from the AUASI and a quality of life question or a "Bother score."

La hiperplasia prostática benigna no siempre requiere tratamiento. ​​​​​​​La decisión de tratar la HPB se basa en la evaluación del impacto de los síntomas en la calidad de vida del paciente, junto con los posibles efectos secundarios del tratamiento. For patients with moderate-to-severe symptoms (e.g., an AUASI score of ≥8), bothersome symptoms, or both, a discussion about medical therapy is reasonable. Available medical therapies for BPH-related lower urinary tract dysfunction include α-adrenergic blockers (e.g., alfuzosin, doxazosin, tamsulosin, terazosin, silodosin), 5α-reductase inhibitors (e.g., finasteride, dutasteride), combination α-adrenergic blockers and 5α-reductase inhibitors, anti-muscarinic agents, phosphodiesterase-5 inhibitors (e.g., tadalafil), and beta-3 adrenergic receptor agonists (e.g., mirabegron).

Los pacientes que no muestran suficiente respuesta a la terapia médica, o que experimentan efectos secundarios significativos con ella, pueden ser derivados para terapias quirúrgicas o ablativas. The American Urological Association (AUA) recommends surgical intervention for patients who have renal insufficiency secondary to BPH, refractory urinary retention secondary to BPH, recurrent urinary tract infections, recurrent bladder stones or gross hematuria due to BPH, and/or LUTS attributed to BPH refractory to and/or unwilling to use other therapies. La resección transuretral de la próstata (TURP) se considera generalmente el estándar de referencia en las comparaciones de los procedimientos para BPH. Minimally invasive surgical treatments (MISTs) including prostatic urethral lift (PUL), water vapor thermal therapy (WVTT), temporarily implanted nitinol devices (e.g., iTind), and aquablation have been developed as alternatives to TURP with the aim of reducing procedure-related morbidity while preserving sexual function.

Permanently implanted prostatic stent devices

Permanently implanted prostatic stent devices represent a distinct category from temporarily implanted nitinol devices (e.g., iTind, which is removed after 5-7 days). Unlike temporary devices that achieve their therapeutic effect through ischemic tissue remodeling, permanently implanted prostatic stent devices exert continuous radial expansion force against the prostatic lobes to maintain luminal patency indefinitely. These devices are designed to be retrievable at any time if clinically warranted.

Legacy permanent prostatic stents

Earlier permanent prostatic stents, including the UroLume Wallstent (American Medical Systems; discontinued) and Memokath/Memotherm devices, were introduced in the 1990s but were subsequently abandoned due to high complication rates. A 2025 systematic review by Cerrato et al encompassing 2,618 patients across 38 studies reported an overall complication rate of 30.8% for legacy permanent stents, including encrustation rates of 12.6%, failure requiring removal or repositioning in 14.8%, urinary tract infection in 17.2%, and epithelial hyperplasia with tissue ingrowth. Importantly, these complications, particularly encrustation, tissue ingrowth, and migration, emerged predominantly beyond the first year of implantation, with progressive accumulation over years of follow-up. This temporal pattern is clinically significant: initially acceptable short-term outcomes did not predict long-term device performance, and the UroLume was ultimately removed from the market by its manufacturer due to these delayed safety concerns. A newer generation of permanent prostatic stent devices has been developed with design features intended to address these historical failure modes, including non-crossing strut configurations to minimize encrustation, nitinol superelasticity for atraumatic radial force, and retrievability via standard endoscopic equipment.

Comparative landscape

A 2026 network meta-analysis by Shin et al (N=21,078 across 103 RCTs) compared the efficacy and safety of MISTs for BPH, confirming TURP as the highest-ranked treatment for symptom improvement and the lowest for surgical reintervention. Neither the ProVee System nor the Zenflow Spring Implant was included in the analysis. The results provide landscape context for established alternatives, but do not allow direct comparison with the devices under review.

ProVee System

The ProVee System for BPH (ProVerum Limited, Dublin, Ireland) consists of the ProVee Expander and Generation II Delivery System. The ProVee Expander is a permanent nitinol implant with 3 apices intended to correspond with the 3 dominant lobes of the prostate (2 lateral lobes and the median lobe). The device applies radial expansion force to the dominant lobes and is available in one universal size. The Generation II Delivery System is a 16 Fr single-use steerable device with integrated imaging (CMOS sensor) and irrigation, facilitating targeted deployment under direct visualization via a transurethral approach. The system allows for staged deployment, enabling the user to visualize the partially deployed expander relative to anatomical landmarks prior to full deployment.

Zenflow Spring Implant

The Zenflow Spring Implant and Delivery System (Zenflow, Inc., South San Francisco, CA) consists of a permanent nitinol spring coil implant constructed from a single wire strand formed into ring elements connected by spine sections. The implant is available in multiple sizes (15-21 mm length) to accommodate prostate lengths between 25 and 45 mm. The device is delivered via a proprietary single-use flexible cystoscope (Spring Scope) with an 11.5 Fr delivery catheter and balloon-anchored positioning system. The ends of the implant have rounded balls to assist in grasping for potential retrieval.

Situación reglamentaria

In December 2025, the ProVee System for BPH (ProVerum Limited) was approved by the U.S. Food and Drug Administration (FDA) through the premarket approval (PMA) process (P250011; product code: MER). The ProVee System is indicated for the treatment of obstructive lower urinary tract symptoms secondary to BPH in men with prostatic urethral lengths greater than or equal to 3.75 cm and prostatic volumes between 30 cc and 80 cc.

In December 2025, the Zenflow Spring Implant and Delivery System (Zenflow, Inc.) was approved by the FDA through the PMA process (P250007; product code: MER). The Zenflow Spring Implant is indicated for the treatment of obstructive lower urinary tract symptoms secondary to BPH in men with prostatic urethral lengths between 25 and 45 mm and prostate volumes between 25 and 80 cc.

Both devices received PMA approval, the highest regulatory bar requiring demonstrated safety and effectiveness through clinical trial data. Neither device has been previously marketed in the United States or any foreign country. The FDA required 60-month post-approval studies for both devices, explicitly citing the precedent that a prior device of this type was removed from the market by its manufacturer due to long-term safety concerns.

Fundamento

Summary of evidence

For individuals who have moderate-to-severe benign prostatic hyperplasia (BPH) with lower urinary tract symptoms who receive a permanently implanted prostatic stent device (e.g., ProVee System, Zenflow Spring Implant), the evidence includes 2 manufacturer-sponsored randomized controlled trials (RCTs) with sham controls, multiple single-arm pilot studies, and systematic reviews of legacy prostatic stents and minimally invasive surgical treatments (MISTs) for BPH. Relevant outcomes are symptoms, functional outcomes, health status measures, quality of life, sexual function, treatment-related morbidity, and long-term device complications. One double-blind, sham-controlled RCT of the ProVee System (N=221) met both co-primary effectiveness endpoints, demonstrating a mean IPSS improvement of 9.5 versus 5.6 for sham at 3 months (p=.001) and a mean percent IPSS improvement of 38.3% from baseline at 12 months (p=.002), with no device- or procedure-related serious adverse events (SAEs). One single-blind, sham-controlled RCT of the Zenflow Spring Implant (N=205 randomized) failed to meet either co-primary effectiveness endpoint in the intent-to-treat (ITT) population; FDA approval was based on a post-hoc modified ITT/intended use (mITT/IU) population that retrospectively excluded 38 erroneously enrolled participants with obstructive median lobe anatomy, in which the responder rate was 59.6% versus 33.3% for sham at 3 months and the mean percent IPSS change was -37.2% at 12 months. One systematic review of prostatic stents (N=2,618 across 38 studies) found high complication rates for legacy permanent stents including encrustation (12.6%), failure requiring removal or repositioning (14.8%), and urinary tract infection (17.2%). No studies have directly compared permanently implanted prostatic stent devices to active treatment alternatives such as TURP or prostatic urethral lift. Both devices received FDA PMA approval in December 2025 with required 60-month post-approval studies, explicitly citing the historical precedent of a prior permanent prostatic stent removed from the market due to long-term safety concerns. Las pruebas son insuficientes para determinar que la tecnología da lugar a una mejora en el resultado neto para la salud.

Definiciones

N/D

Exención de responsabilidad

Las políticas médicas de Capital Blue Cross se utilizan para determinar la cobertura de tecnologías, procedimientos, equipos y servicios médicos específicos. Estas políticas médicas no constituyen un consejo médico y están sujetas a cambios según lo permita la ley o la evidencia clínica aplicable de las pautas de tratamiento independientes. Los proveedores que brindan tratamiento son individualmente responsables de los consejos médicos y el tratamiento de los miembros. Estas políticas no son una garantía de cobertura o pago. El pago de las reclamaciones está sujeto a la determinación del programa de beneficios del miembro y la elegibilidad en la fecha del servicio, y a la determinación de que los servicios son médicamente necesarios y apropiados. El procesamiento final de una reclamación se basa en los términos del contrato que se aplican al programa de beneficios de los miembros, incluidas las limitaciones y exclusiones de beneficios. Si un proveedor o miembro tiene alguna pregunta sobre esta política médica, debe comunicarse con Servicios para proveedores o Servicios para miembros de Capital Blue Cross.

Información de codificación

Nota: esta lista de códigos puede no ser exhaustiva y los códigos están sujetos a cambios en cualquier momento. La identificación de un código en esta sección no denota cobertura, ya que la cobertura está determinada por los términos de la información de beneficios del miembro. Además, no todos los servicios cubiertos son elegibles para un reembolso por separado.

Investigational; therefore, not covered

Referencias

1. Lepor H. Pathophysiology, epidemiology, and natural history of benign prostatic hyperplasia. Rev Urol. 2004; 6 Suppl 9(Suppl 9): S3-S10. PMID 16985922
2. Cerrato C, Antoniou V, Somani BK. Prostatic stents: a systematic review and analysis of functional outcomes and complication rate. Prostate Cancer Prostatic Dis. Jun 2025; 28(2): 318-327. PMID 39516581
3. Shin BNH, Maksoud R, Tan S, et al. Efficacy and Tolerability Outcomes of Minimally Invasive Surgical Treatments for Benign Prostatic Hyperplasia: A Random-Effects Network Meta-Analysis. World J Mens Health. Enero de 2026; 44(1): 49-63. PMID 40759591
4. Administración de Medicamentos y Alimentos de Estados Unidos. Premarket Approval: ProVee System for BPH (P250011). December 9, 2025. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm?id=P250011.
5. Administración de Medicamentos y Alimentos de Estados Unidos. Premarket Approval: Zenflow Spring Implant and Delivery System (P250007). December 11, 2025. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm?id=P250007. Último acceso el 18 de abril de 2026.
6. Barry MJ, Fowler FJ, O'Leary MP, et al. The American Urological Association symptom index for benign prostatic hyperplasia. The Measurement Committee of the American Urological Association. J Urol. Nov 1992; 148(5): 1549-57; discussion 1564. PMID 1279218
7. Rosen RC, Cappelleri JC, Smith MD, et al. Development and evaluation of an abridged, 5-item version of the International Index of Erectile Function (IIEF-5) as a diagnostic tool for erectile dysfunction. Int J Impot Res. Dec 1999; 11(6): 319-26. PMID 10637462
8. Rosen RC, Catania JA, Althof SE, et al. Development and validation of four-item version of Male Sexual Health Questionnaire to assess ejaculatory dysfunction. Urology. May 2007; 69(5): 805-9. PMID 17482908
9. Kaplan SA, Parekattil SJ, Wu NZ, et al. 12-Month Outcomes From a Randomized, Sham-Controlled Trial Evaluating a Novel Prostatic Urethral Stent for the Treatment of Benign Prostatic Hyperplasia. J Urol. Apr 2026; 215(4): 421-430. PMID 41396103
10. Administración de Medicamentos y Alimentos de Estados Unidos. Summary of Safety and Effectiveness Data (SSED). Zenflow Spring Implant and Delivery System. https://www.accessdata.fda.gov/cdrh_docs/pdf25/P250007B.pdf.
11. Administración de Medicamentos y Alimentos de Estados Unidos. Summary of Safety and Effectiveness Data (SSED). ProVee System for BPH. https://www.accessdata.fda.gov/cdrh_docs/pdf25/P250011B.pdf.
12. Lerner LB, McVary KT, Barry MJ, et al. Management of Lower Urinary Tract Symptoms Attributed to Benign Prostatic Hyperplasia: AUA GUIDELINE PART II-Surgical Evaluation and Treatment. J Urol. Octubre de 2021; 206(4): 818-826. PMID 34384236
13. Sandhu JS, Bixler BR, Dahm P, et al. Management of Lower Urinary Tract Symptoms Attributed to Benign Prostatic Hyperplasia (BPH): AUA Guideline Amendment 2023. J Urol. Enero de 2024; 211(1): 11-19. PMID 3770