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VIVIVE


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Viveve, Inc., the wholly owned subsidiary of Viveve Medical, Inc., is a women's intimate health company based in Englewood, Colorado. Viveve is committed to advancing new solutions to improve women’s overall well-being and quality of life. The company is focused on the commercialization of a revolutionary, non-surgical, non-ablative medical device that remodels collagen and restores vaginal tissue. The internationally patented Viveve® System incorporates Cryogen-cooled Monopolar Radiofrequency (CMRF) technology to uniformly deliver volumetric heating while gently cooling surface tissue to generate neocollagenesis in a single in-office session. In the United States, 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 indications in more than 50 countries.

Viveve continues to advance its clinical development program in stress urinary incontinence (SUI). As reported in December 2020, FDA approved changes to the U.S. pivotal PURSUIT trial protocol are intended to strengthen the overall study and its potential to achieve its primary efficacy endpoint. Study changes including an increase in the trial’s size and more strict patient selection criteria were a result of guidance from Viveve’s Clinical Advisory Board upon review of positive results from the Company’s SUI feasibility and preclinical studies. 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 amendments to the IDE protocol as reported on December 10, 2020. Initiation of the trial was reported on January 21, 2021 and subject enrollment is underway. If positive, results from the PURSUIT trial may support a new SUI indication in the U.S.

IN THThe Viveve System delivers a single-session treatment to generate collagen and restore tissue. The dual mode VIVEVE TREATMENT COOLS AND PROTECTS THE SURFACE WHILE HEATING THE DEEPER TISSUE. The Viveve Treatment is both safe and effective.

INCONTROL PRODUCTS strengthen the pelvic floor muscles and calm the detrusor muscle using a patented electrostimulation with high and low levels of stimulation to treat urinary and fecal incontinence. Attain is a FDA-cleared device.

The Viveve Treatment

The VIVEVE TREATMENT IS DELIVERED VIA THE VIVEVE SYSTEM, a patented, cryogen-cooled radiofrequency device that rebuilds natural collagen to improve the structural integrity of the vagina and to support the urethra. The system is designed to treat women who are experiencing urinary incontinence – leaking urine when laughing, coughing, sneezing, or jumping; sexual dysfunction and vaginal laxity – the stretching and expansion of vaginal tissue after childbirth, with age or due to hormonal changes. Studies have shown sustained results to 12 months.E C

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