Stratus Medical today said it received FDA clearance for its Vesta RF Cannula for radiofrequency heat lesion procedures.
The Vesta cannula was designed to offer pain relief in clinical scenarios where the company’s Nimbus RF Multitined Expandable Electrode is not indicated.
The cannula is insulated with an active tip at the distal end. It is designed for use with compatible RF generators with the rated voltage less than or equal to 280V. The device is sterilized and intended for single use only, according to the company.
Vesta RF Cannula design has a rigid cannula with a tip that is used for insertion into target tissues. It is capable of placement through radiography and traditional motor/sensory stimulation protocols.
Vesta has been CE marked since 2018 and has been successfully used in thousands of procedures in Australia and Brazil. The new FDA clearance allows Stratus Medical to market the cannula in the U.S.
“Vesta allows us to deliver a more complete product offering and better serve our customers in alignment with their financial needs. Our focus is the rapidly expanding global radiofrequency (RF) for the pain market, and the Stratus Medical mission is to reduce pain and suffering and improve quality of life for chronic pain patients by advancing RF technology for the treatment of pain,” CEO Bret Boudousquie said in a news release. “We will continue to invest in product development in the RF space and deliver new product launches with the goal to improve patient outcomes.”