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    New Products: Nasal spray to treat nocturia receives FDA approval

    Other products discussed include catheter sets to make the ordering process easier, a micro-US/MRI fusion application for prostate imaging, an international prostate registry for HIFU and more.

    Nasal spray to treat nocturia receives FDA approval

    Milford, PA—The FDA has approved Serenity Pharmaceuticals’ desmopressin acetate (Noctiva) nasal spray for the treatment of nocturia due to nocturnal polyuria. This is the first FDA-approved therapy for the condition, according to the company. The product is a vasopressin analogue and works by temporary decreasing urine production, which eliminates the need for the patient to urinate during sleep. The approval was based on two randomized, placebo-controlled studies that showed a significant decrease in the mean number of nocturic voids. The most common side effects of desmopressin nasal spray include nasal discomfort, nasal congestion, increased blood pressure, and low sodium levels in the blood.

    For more information, visit www.serenitypharma.com.

     

    Catheter sets aim to make ordering process easier

    Bloomington, IN—Cook Medical has added two new sets to its Universa line for percutaneous urinary drainage. Both the introductory sets for initial catheter placement and the suprapubic sets for suprapubic drainage include a catheter and accessories for specific procedures. By creating drainage sets, Cook says the ordering process for customers will be simplified. The brand also features ureteral stents and Foley catheters.

    For more information, visit www.cookmedical.com

     

    Prostate micro-US/MRI fusion application introduced

    Toronto—Exact Imaging has introduced an application to complement its ExactVu micro-ultrasound prostate imaging and biopsy system. The original ExactVu platform visualizes the majority of prostate cancers located in the peripheral zone. The new FusionVU micro-US/MRI fusion system addresses a minority of cases, including patients with previous negative biopsies or those with exclusive anterior lesions. FusionVU micro-US/MRI uses an approach called Cognitive Assist where the urologist can import radiologic reports from MRI scans or import annotated MR images themselves. The imported images are co-aligned with the live ExactVu micro-ultrasound images so urologists can use MRI-identified lesions to ensure they are not missed in the total biopsy procedure. The FusionVu application does not require additional hardware or radiologic software and runs on the ExactVu platform.

    For more information, visit www.exactimaging.com.

    Next: International prostate registry for HIFU launched

    International prostate registry for HIFU launched

    Charlotte, NC—SonaCare Medical has launched an International Sonablate HIFU Registry. The High Intensity Focused Ultrasound Evaluation and Assessment of Treatment (HEAT) Registry will be a web-based platform for storing data on patients treated with Sonablate prostate tissue ablation. It operates on the REDCap software system and is browser-operated. The registry will provide longitudinal data on the efficacy of HIFU and will be solely overseen by academic professionals. The HEAT registry has already enrolled more than 1,500 international patients and U.S. patient enrollment will begin later in April.

    For more information, visit www.SonaCareMedical.com.

     

    Study: Test helps reduce biopsies, improves PCa detection

    West Palm Beach, FL—According to a clinical study, MDNA Life Sciences’ Prostate Core Mitomic Test (PCMT) reduces unnecessary biopsies and improves cancer detection. The study of 1,467 men, published in American Health and Drug Benefits (2016; 9(9):897-502), evaluated whether a positive or negative PCMT test result had an impact on repeat biopsy rates compared to patients who did not incorporate the test into their treatment plan. Findings from the study support continued use of PCMT to better select men for repeat biopsies since repeat biopsy rates decreased 8-fold for men who received a negative PCMT test result. Men who received positive results from the PCMT also proceeded to repeat biopsy an average of 2.5 months earlier than men who did not have PCMT. MDNA plans to leverage the results from the study to support reimbursement for testing patients covered by Medicare.

    For more information, visit www.mdnalifesciences.com.

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    Ben Schwartz
    Ben Schwartz is Associate Editor, Contemporary OB/GYN.

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