POLICY NUMBER

A.7.01.181

DESCRIPTION

Benign prostatic hyperplasia (BPH) is a common condition in older individuals that can lead to lower urinary tract symptoms (LUTS) including increased urinary frequency, urgency, hesitancy, nocturia, and a weak urinary stream. Permanently implanted prostatic stent devices have been proposed as a minimally invasive treatment for LUTS secondary to BPH. These devices are permanently placed in the prostatic urethra where they exert continuous radial expansion force to maintain luminal patency and improve urine outflow. Unlike temporarily implanted nitinol devices that facilitate tissue reshaping through short-term ischemic remodeling, permanently implanted prostatic stent devices remain in situ indefinitely.

Benign Prostatic Hyperplasia

Benign prostatic hyperplasia (BPH) is a common disorder among older individuals that results from hyperplastic nodules in the periurethral or transitional zone of the prostate. The clinical manifestations of BPH include increased urinary frequency, nocturia, urgency or hesitancy to urinate, and a weak stream when urinating. The urinary tract symptoms often progress with worsening hypertrophy and may lead to acute urinary retention, incontinence, renal insufficiency, and/or urinary tract infection. 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."

Benign prostatic hyperplasia does not necessarily require treatment. The decision on whether to treat BPH is based on an assessment of the impact of symptoms on quality of life along with the potential side effects of treatment. For patients with moderate-to-severe symptoms (eg, 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 (eg, alfuzosin, doxazosin, tamsulosin, terazosin, silodosin), 5α-reductase inhibitors (eg, finasteride, dutasteride), combination α-adrenergic blockers and 5α-reductase inhibitors, anti-muscarinic agents, phosphodiesterase-5 inhibitors (eg, tadalafil), and beta-3 adrenergic receptor agonists (eg, mirabegron).

Patients who do not have sufficient response to medical therapy, or who are experiencing significant side effects with medical therapy, may be referred for surgical or ablative therapies. 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 lower urinary tract symptoms (LUTS) attributed to BPH refractory to and/or unwilling to use other therapies. Transurethral resection of the prostate (TURP) is generally considered the reference standard for comparisons of BPH procedures. Minimally invasive surgical treatments (MISTs) including prostatic urethral lift (PUL), water vapor thermal therapy (WVTT), temporarily implanted nitinol devices (eg, 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 (eg, 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 randomized controlled trials) 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.

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.

POLICY

The use of permanently implanted prostatic stent devices (eg, ProVee System, Zenflow Spring Implant) is considered investigational as a treatment of lower urinary tract symptoms due to benign prostatic hyperplasia.

POLICY EXCEPTIONS

Federal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.

POLICY HISTORY

09/01/2026: New policy added. Approved by the Medical Policy Advisory Committee.

SOURCE(S)

Blue Cross Blue Shield Association policy # 7.01.181

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

Investigational Codes

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