The recent FDA clearance allows Stratus Medical to market the Vesta RF Cannula in the United States and continue our expansion into new markets across the world
The FDA Center for Devices and Radiological Health. (Credit: The U.S. Food and Drug Administration/Wikipedia.)
Stratus™ Medical, a company focused on advancing radiofrequency (RF) ablation treatment for chronic pain, announced today FDA clearance for the Vesta RF Cannula for use in radiofrequency (RF) heat lesion procedures for the relief of pain and first Vesta patient treatments in the United States.
Vesta was developed to provide our customers and their patients a high quality and cost-effective RF cannula to treat pain in clinical scenarios where our Nimbus® RF Multitined Expandable Electrode, that provides a large volume lesion for the treatment of pain, is not indicated.
Vesta has been CE marked since 2018 and been used successfully in thousands of procedures in Australia and Brazil. The recent FDA clearance allows Stratus Medical to market the Vesta RF Cannula in the United States and continue our expansion into new markets across the world.
Bret Boudousquie, Stratus Medical CEO shared, “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 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. We will continue to invest in product development in the RF space and deliver new product launches with the goal to improve patient outcomes.”
Dr. Alan Swearingen, with Space City Pain in Houston Texas, was the first interventional pain medicine physician to use Vesta in a clinical case and commented, “My colleagues Dr. Eduardo Garcia and Dr. Jeffery Cannella have been using Nimbus for some time and introduced me to the technology and Stratus Medical. Today we had a patient that I thought would benefit from Vesta and both my patient and I are very pleased with the outcome. With its high quality, great value, and proven effectiveness, I foresee many more of my patients benefiting from Vesta in the future.”
About Stratus Medical – Stratus Medical is a medical device company focused on reducing pain and suffering and improving the quality of life for chronic pain patients through innovation. Stratus Medical is headquartered in Salt Lake City, UT where we manufacture the Nimbus® RF Multitined Expandable Electrode that was developed to address the need for an easy to use and cost-effective RF device that provides a large volume lesion to treat pain.
Source: Company Press Release