Viveve Medical has received a nod from FDA to continue enrollment in a clinical trial to evaluate a technology to improve sexual function in women following vaginal childbirth. The Viveve Treatment of the Vaginal Introitus to EValuate Safety and Efficacy (VIVEVE II) trial is a randomized, double-blinded, and sham-controlled trial with a planned enrollment of about 250 patients at up to 25 study sites in the U.S. and Canada.
The primary efficacy endpoint is intended to be the mean change from baseline in the total Female Sexual Function Index (FSFI) at 12 months. Subjects will also be assessed for safety over the 12 months. The approved protocol also includes a variety of secondary and exploratory endpoints measured at six months post-treatment that address the efficacy of and improvement in FSFI domain scores. The Englewood, CO.-based company said it could potentially submit to FDA for clearance in late 3Q19 or early 4Q19.
“Vaginal laxity is the only first indication we’re going after,” Scott Durbin CEO of Viveve Medical, told MD+DI. “We’ve also announced pilot study results with the same therapy - applied in a different way- for improvement of pre-menopausal stress urinary incontinence (SUI). We have a submission with Health Canada for what we call LIBERATE international and that’s for an SUI indication. In the next 30 days we’re intending to submit a new IDE to FDA for a large randomized trial that would result in an SUI indication.”
Viveve Medical’s procedure delivers RF energy deeply into soft tissues – which results in neocollagenesis, or a straightening or tightening of the skin. The company said the technology is applied in a single treatment and in an office setting. The physician delivers the RF around the introitus and the procedure takes about 30 minutes.
“We put about $20 million of R&D work into modifying the system specifically for a vaginal application,” Durbin said. “We began in vaginal laxity – so postpartum women who have an overstretching of the vaginal introitus during natural childbirth and have issues with dissatisfied sex; loss of sexual function; and stress incontinence.”
Treating vaginal laxity is a procedure that’s quickly growing in popularity. Earlier this year, an obstetrics and gynecologist specialist based out of Lubbock, TX spoke on the importance of the procedure and how it was changing patient’s lives. Jennifer Owen, MD spoke to MD+DI about InMode’s Votiva device, which uses RF energy instead of monopolar RF energy to treat patients
While these devices can have benefits for the patients, the technologies would probably would not be able to garner reimbursement. However, Viveve Medical’s plan to treat incontinence could help put it in a position to net reimbursement for one of its indications – should it manage to get a nod from FDA.
“With laxity, we won’t likely see reimbursement,” Durbin said. “On the stress incontinence side we don’t know how it’s going to evolve but given the significance of the unmet need and the medical orientation of this particular indication and how many women it [impacts] we’ll likely … make a decision to go after reimbursement.”