The Viveve PURSUIT Trial is a pivotal U.S. Stress Urinary Incontinence trial that has completed all subject 12-month follow-up visits
Topline results of primary efficacy endpoint planned in January 2023.Read More
Pivotal U.S. Investigational Device Exemption (IDE) cleared trial
PURSUIT is a randomized, double-blinded, sham-controlled, IDE-cleared trial that enrolled 415 subjects with moderate SUI at approximately 30 study sites in the United States. Subjects were randomized in a 2:1 ratio to the active Viveve treatment or an inert sham treatment.
Viveve Medical, Inc. (Viveve), is a women's health company focused on the treatment of female stress urinary incontinence (SUI). Based in Englewood, Colorado, the company is conducting a pivotal U.S. clinical trial called PURSUIT, using its novel, dual-energy treatment for SUI in women. The internationally patented Viveve® System incorporates Cryogen-cooled Monopolar Radiofrequency (CMRF) technology to uniformly provide an endovaginal treatment that is non-ablative. In the U. S., the Viveve System is cleared by the Food and Drug Administration (FDA) for use in general surgical procedures for electrocoagulation and hemostasis. International regulatory approvals and clearances have been received for vaginal laxity and/or improvement in sexual function and/or urinary incontinence. Viveve's current commercial and market development efforts focus on the U.S. and Asia Pacific regions targeting urogynecology, urology, and gynecology core specialties.
Viveve received FDA approval of its Investigational Device Exemption (IDE) application to conduct the multicenter, randomized, double-blinded, sham-controlled PURSUIT trial for improvement of SUI in women in July 2020, and FDA approval of its requested IDE protocol amendments in December 2020. The clinical trial was initiated in January 2021, and completion of subject enrollment was announced mid-December 2021. Completion of subject follow-up visits was announced on December 15, 2022, and topline results will be reported in January 2023. If positive, results from the PURSUIT clinical trial may support a new SUI indication in the U.S.
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