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# Viveve Resubmits Urinary Incontinence Trial IDE
- URL: https://www.fdaweb.com/viveve-resubmits-urinary-incontinence-trial-ide/
- Published: 2020-04-15T12:00:00.000Z
- Updated: 2026-09-14T16:11:23.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5146576

Viveve Medical says it has resubmitted to FDA its IDE for approval to begin a stress urinary incontinence (SUI) multi-center trial now known as PURSUIT (Prospective U.S. Radiofrequency SUI Trial). The company [says](https://www.marketwatch.com/press-release/viveve-resubmits-us-investigational-device-exemption-to-fda-to-conduct-new-pursuit-trial-for-improvement-of-stress-urinary-incontinence-2020-04-15?tesla=y&ref=fdaweb.com) the trial is designed to evaluate the safety and efficacy of Viveve's CMRF treatment versus an inert sham tip for the improvement of SUI in women.

The company says that following its original IDE submission to conduct a U.S. SUI trial, it completed multiple rounds of discussions with FDA. Based on the discussions, it says, the resubmitted IDE addresses specific protocol requests and provides positive results from additional *in vivo* animal safety testing requested by the agency.

Viveve says its system incorporates 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 FDA for use in general surgical procedures for electrocoagulation and hemostasis.