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Women’s health through science

Women’s healthcare company Viveve (Denver, Colo.), makers of the Viveve System, a patented Cryogen-Cooled Monopolar Radiofrequency (CMRF) device, is committed to providing clinically-proven, cutting-edge treatments for women. Its robust clinical team, patented RF technology, and well-demonstrated commitment to science with Level I clinical evidence has set the company apart from the field. The device itself is designed specifically for intimate use, unlike many competitors which were adapted for this indication in response to growing demand.

“Viveve’s ongoing commitment to science and Level I clinical evidence is demonstrated in the dedicated resources and funding devoted to building a highly experienced clinical/medical team,” said Stacie Bell, Ph.D., senior director of preclinical research and clinical affairs at Viveve.

“We have intentionally selected veteran clinical program managers to oversee therapeutic areas and conduct studies properly, as well as leaders with years of experience in medicine, technology and clinical research to guide the team, projects and ongoing research. Also, the continued support from leadership to conduct proper research, both clinically and preclinically, is phenomenal.”

The Viveve System delivers cooled monopolar RF in a comfortable, 30-minute treatment with no downtime. The CMRF technology is purpose-built to target vaginal tissue. The integrated cooling allows RF energy to penetrate 3 to 5 mm deep without surface heat build-up, more deeply than competing RF devices, according to Dr. Bell.

“People often ask us why this device cannot be used in different areas of the body, but that goes back to the unique design of the system,” she explained. “Every part of the device is strategically crafted for the treatment of the vaginal canal to provide optimal outcomes for women. From the handpiece, to the size of the treatment tip, every part is ergonomically engineered to enter the vaginal canal comfortably and safely, while effectively treating tissue. We not only administer RF across the treatment tip consistently, we protect the mucosal surface with our cryogen cooling system,” Dr. Bell continued. “This allows more time on tissue for deep, volumetric heating of the lamina propria connective tissue down to the muscularis. Every component of the device was intentionally created to treat tissue layers of the vaginal canal,” she said.

“With the original VIVEVE I Study, the largest randomized, double-blinded and sham-controlled study in this space, we showed our commitment to high quality scientific research,” Dr. Bell stated. “We’ve conducted or supported many studies and continue to build our clinical database with further Viveve-sponsored research.”

Dr. Bell added that Viveve recently received an Investigational Device Exemption (IDE) from the FDA to evaluate the Viveve System in the United States for the treatment of sexual function in women after childbirth.

“We also plan to sponsor studies for stress urinary incontinence (SUI) in Canada (LIBERATE International) and file an IDE in the U.S. to conduct a large randomized, blinded, sham-controlled study (LIBERATE US). Also, there are several investigator-sponsored trials underway domestically and internationally, including an SUI pilot study in Canada with 36 enrolled patients, and the data look very good at interim analysis.”