Tutera Medical® Now is a Viveve® Solutions Provider
SCOTTSDALE, Ariz., September 20, 2018 (Newswire.com) - Tutera Medical offers bioidentical hormone replacement pellet therapy for both men and women. They are part of the SottoPelle network, founded by bioidentical hormone replacement pioneer Dr. Gino Tutera. The distinguished medical practice of Tutera Medical is now also a proud provider of Viveve Solutions to its many patients. Viveve offers clinically proven, innovative, nonsurgical treatments to improve women’s intimate health. As a health and wellness medical practice, the inclusion of Viveve seemed like a perfect hit. Viveve recently announced its FDA Approval of IDE to Conduct VIVEVE II Clinical Study. This trial is expected to begin in the second quarter of 2018, with future results potentially supporting a marketing application for an expanded U.S. indication for the improvement of sexual function in women.
This trial received approval of its Investigational Device Exemption (IDE) application from the U.S. Food and Drug Administration (FDA). The approval allows the company to conduct the Viveve Treatment of the Vaginal Introitus to evaluate Safety and Efficacy (VIVEVE II) clinical trial to assess the safety and effectiveness of the Viveve® System for the improvement of sexual function in women following vaginal childbirth. Tutera Medical is confident of Viveve success and the potential benefits it offers to women.
Adding Viveve to our many therapeutic options is one that just makes sense for our patients.
CarolAnn Tutera, President - Tutera Medica
The team at Tutera Medical has always led the field with medical innovation that has helped patients live longer, healthier and have enhanced quality of lives. CarolAnn Tutera, the president of Tutera Medical stated: “Adding Viveve to our many therapeutic options is one that just makes sense for our patients.”
About Tutera Medical
Tutera Medical is highly skilled and experienced in Menopause and Andropause management and have a compassionate understanding of how unbalanced hormones impact every system in the body. During this time the symptoms can range from mild to unbearable. Our medical team is thoroughly trained to recognize, diagnose and treat the many health concerns that occur during aging. Tutera Medical was an early advocate of focused treatment to this very specific population. They have decades of success in treating the sub specialty of mid to late life hormonal imbalance – Midiatrics™.
About Viveve
Viveve Medical, Inc. is a women's intimate health company passionately committed to advancing new solutions to improve women's overall well-being and quality of life. The internationally patented Viveve® System, that delivers the GENEVEVE™ treatment, incorporates clinically-proven cryogen-cooled, monopolar radiofrequency (CMRF) technology to uniformly deliver volumetric heating while gently cooling surface tissue to generate robust neocollagenesis in a single, in-office session. International regulatory approvals and clearances have been received for vaginal laxity and/or improvement in sexual function indications from over 55 countries. Viveve received approval of an Investigational Device Exemption (IDE) application from the U.S. Food and Drug Administration (FDA) in March of 2018 to proceed with VIVEVE II, a multicenter, randomized, double-blind, sham-controlled study to assess improvement of sexual function in women following childbirth. Initiation of the trial is expected to begin in the second quarter of 2018 and, if successful, could support a marketing application for a new US commercial indication. Currently, in the United States, the Viveve® System is cleared by the FDA for use in general surgical procedures for electrocoagulation and hemostasis.
Viveve@ is a registered trademark of Viveve, Inc. Geneveve is a trademark of Viveve, Inc.
Tutera Medical® Media contact:
CarolAnn Tutera
(480) 874-1515
info@tuteramedical.com
Viveve ®Media contact:
Kelly Wakelee Berry & Company Public Relations
(212) 253-8881
kwakelee@berrypr.com
Source: Tutera Medical
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