New Products: FDA expands indications for BPH treatment system


Other products discussed in this round-up include a rectal spacer, an imaging agent for prostate cancer, and an app to help health care professionals choose the safest contrast agent when imaging patients with renal impairment.

FDA expands indications for BPH treatment system

NeoTract recently announced that the FDA has cleared new indications for the UroLift System for the treatment of BPH. These expanded indications mean that patients who have an obstructive median lobe and those as young as 45 years of age are now eligible to receive treatment with the UroLift System for their BPH symptoms. Previously, the UroLift System was contraindicated in patients with an obstructive median lobe and only cleared for use in men 50 years of age or older. The MedLift study provided clinical evidence to support the safe and effective treatment of obstructive median lobes and to remove the contraindication, according to NeoTract.

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Commercial insurer deems rectal spacer medically necessary

Commercial health plan provider Aetna, Inc. recently published an update to its Clinical Policy Bulletin 0926 stating that Aetna considers transperineal periprostatic placement of biodegradable material (SpaceOAR hydrogel) medically necessary for reducing rectal toxicity in men undergoing radiotherapy for prostate cancer, Augmenix, Inc. reported. The full policy can be found at Under the policy update, patients covered by Aetna will have greater access to the SpaceOAR hydrogel procedure, Augmenix said.

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Imaging agent added to NCCN prostate cancer guidelines

Fluciclovine F 18 injection (Axumin) has been added to the National Comprehensive Cancer Network Practice Guidelines in Oncology for Prostate Cancer (Version 1.2018). The updated NCCN guidelines state that F-18 fluciclovine positron emission tomography/computed tomography or PET/magnetic resonance imaging should be considered in the clinical workup of patients with recurrence or progression of their prostate cancer. This recommendation is based on uniform NCCN consensus that the intervention is appropriate. Fluciclovine F 18 is a novel molecular imaging agent indicated for use in PET imaging to identify suspected sites of prostate cancer recurrence in men who have elevated blood levels of PSA following prior treatment. It is the first FDA-approved F-18 labeled PET imaging agent indicated in patients with suspected recurrent prostate cancer, according to Blue Earth Diagnostics.

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App helps health care professionals choose contrast agent

Contrast Media: NSF vs. CIN is an app designed by academic radiologists to help health care professionals choose the safest contrast agent (iodine or gadolinium) when imaging patients with renal impairment. The app provides a simple and practical approach to minimize the risk of developing nephrogenic systemic fibrosis versus contrast-induced nephropathy.

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FDA approves first treatment for non-metastatic CRPC

The FDA has approved apalutamide (ERLEADA) for the treatment of patients with non-metastatic, castration-resistant prostate cancer. This is the first FDA-approved treatment for non-metastatic, castration-resistant prostate cancer. The safety and efficacy of apalutamide were based on SPARTAN, a randomized phase III trial of 1,207 patients with non-metastatic, castration-resistant prostate cancer. Patients in the trial received either apalutamide or a placebo. All patients were also treated with hormone therapy, either with gonadotropin-releasing hormone analog therapy or surgical castration. The median metastasis-free survival for patients taking apalutamide was 40.5 months compared to 16.2 months for patients taking the placebo.

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FDA approves new indication for prostate cancer treatment

The FDA has approved a new indication for abiraterone acetate (ZYTIGA) in combination with prednisone for the treatment of patients with metastatic high-risk castration-sensitive prostate cancer, according to Janssen. The approval is based on phase III data from the pivotal LATITUDE clinical trial, which found that in patients with metastatic high-risk castration-sensitive prostate cancer, abiraterone in combination with prednisone reduced the risk of death by 38% compared to placebo. Abiraterone is also indicated for the treatment of metastatic castration-resistant prostate cancer.

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Insurer issues positive coverage decision for prostate cancer test

CareFirst BlueCross BlueShield has reached a positive coverage decision for Exosome Diagnostics, Inc.’s ExoDx Prostate (IntelliScore) (EPI) test. This coverage decision is based in part on results from an evidence development study conducted as part of a collaboration between CareFirst and Exosome Diagnostics, the developer of the EPI test. The EPI test improves both cost and quality outcomes for patients, helping urologists assess whether an individual presenting for an initial prostate biopsy is at greater risk for high-grade cancer and avoiding the cost and complications associated with unnecessary prostate biopsies as well as overtreatment of low-risk prostate cancer. Separately, Exosome Diagnostics recently made a series of announcements about contracts to provide laboratory services and EPI testing to three major U.S. preferred provider organizations. The PPOs are Three Rivers Provider Network, FedMed, Inc., and America’s Choice Provider Network, which together provide access to 82 million members across the U.S.

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