Thermi® Statement on the FDA Inquiry into “Vaginal Rejuvenation” Medical Devices

Thermi® Statement on the FDA Inquiry into “Vaginal Rejuvenation” Medical Devices
 
 

To our valued ThermiVa customers,

 

As you may have heard, the FDA recently asked seven companies to provide information on the cleared indications for various products used in a procedure that FDA calls “vaginal rejuvenation.”  ThermiGen® received one of these requests and we are responding promptly. We will continue to respond to any additional questions the FDA might have about our products because the safety, efficacy, and compliance of our products is our highest priority.

ThermiVa is a non-ablative RF application, which was cleared in 2013 and 2018 for use in dermatological and general surgical procedures for electrocoagulation and hemostasis, as developed in accordance with FDA guidance

ThermiGen is committed to marketing all of our products in accordance with their cleared indications. In the U.S., we promote ThermiVa for electrocoagulation and hemostasis in dermatological and general surgical procedures, and we support a professional training program for the appropriate use of all ThermiRF® equipment.

ThermiVa is supported by a clinical trial program involving 65 patients at nine sites in the US designed to demonstrate ThermiVa’s ability to safely and effectively address common intimate health conditions. In Europe, ThermVa is approved to treat vulvovaginal laxity based on clinical trial results. Worldwide, more than 103,700 ThermiVa treatments have been successfully performed since 2015, and ThermiGen has not received any reportable events based on reported information.

Since the safety of our consumers is our utmost consideration, we will continue to work closely with the FDA to ensure we align with all applicable laws and regulations regarding the marketing of our products. At the same time, we will continue to educate both physicians and patients on the correct use of our products, so that they can make the most appropriate treatment decisions to maintain and enhance patient health.

For further information, please contact:

Sheetal Davitt

SVP Global Marketing

sdavitt@thermi.com