Medical Policies - Surgery

Optilume (Drug Coated Balloon) for the Treatment of Urethral Stricture Conditions


Effective Date:10-15-2018



The use of Optilume™ (a drug-coated balloon [DCB]), is considered experimental, investigational and/or unproven for all indications including but not limited to the treatment of urethral stricture conditions.


The Optilume™ drug-coated balloon (DCB), developed by Urotronic, based in Plymouth, MN, offers a minimally-invasive treatment option for men suffering from urinary track conditions like benign prostatic hyperplasia (BPH), urethral and ureteral strictures, and bladder neck contractures (BNC). BPH affects 70% of men 60-69 years of age and 80% of those 70 years of age or older. The prevalence of BPH and lower urinary tract issues rises markedly with increased age.

Urethral strictures are often caused by infections, trauma and other medical procedures that injure the lining of the urethra. Close to 95-98% of urethral strictures in the United States are treated with endoscopic means, meaning with a dilation or urethrotomy. An open surgical procedure called urethroplasty, another treatment option for urethral stricture, is noted to have a better success rate however, it may require a longer recovery and possible side effects.

The DCB is a guidewire compatible catheter with a tapered atraumatic tip. The distal end of the catheter has an inflatable balloon coated with a proprietary coating containing the drug paclitaxel that facilitates the drug's transfer to the urethral wall upon inflation.


This medical policy was developed December 2017. A search of peer reviewed literature identified very limited scientific information regarding this new technology. Urotronic web site notes that Optilume is currently under clinical investigation to determine safety and efficacy and is not approved for sale in any market.

A U.S. based early feasibility trial titled “Re-establishing Flow Via Drug Coated Balloon for The Treatment of Urethral Stricture Disease (ROBUST-II)” will be conducted at five medical centers around the country including the University of Iowa, University of Utah, Eastern Virginia Medical Center and the University of Minnesota and Metro Urology in Minneapolis. The trial will gather information on the feasibility of the drug-coated balloon. This will be a five-year study of fifteen male patients treated with the Optilume device. Estimated study completion date is December 2022. (2)


Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply. If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.



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Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations.

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps.


The following codes may be applicable to this Medical policy and may not be all inclusive.

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ICD-9 Diagnosis Codes

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ICD-9 Procedure Codes

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ICD-10 Diagnosis Codes

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ICD-10 Procedure Codes

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Medicare Coverage:

The information contained in this section is for informational purposes only. HCSC makes no representation as to the accuracy of this information. It is not to be used for claims adjudication for HCSC Plans.

The Centers for Medicare and Medicaid Services (CMS) does not have a national Medicare coverage position. Coverage may be subject to local carrier discretion.

A national coverage position for Medicare may have been developed since this medical policy document was written. See Medicare's National Coverage at <>.


1. Optilume Drug Coated Balloon. Manufacturer Information. Available at: <>. (accessed 12/13/2017).

2. U.S. National Library of Medicine. Robust I Pilot Study (ROBUST). NCT03014726 Available at: <> (accessed 12/14/2017)

Policy History:

10/15/2018 Reviewed. No changes.
1/1/2018 New medical document. The use of Optilume™ (a drug coated balloon [DCB]), is considered experimental, investigational and/or unproven for all indications including but not limited to the treatment of urethral stricture conditions.

Archived Document(s):

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