Stratus Medical this week said it received CE mark approval for its Nimbus RF multitined expandable electrode and Vesta RF cannula.
The Nimbus multitined expandable electrode is designed to create a large 8 mm to 10 mm prolate spheroid lesion for pain relief. More than 100,000 of the devices have been used to treat chronic pain in patients in Australia, Brazil, Canada, U.K. and the U.S.
Stratus Medical designed the Vesta radio frequency (RF) cannula for clinical situations where the Nimbus large volume lesion is not indicated. It has an insulated cannula with an active tip to create an RF heat lesion for pain relief.
“Stratus Medical has a high commitment to quality to meet our customers’ needs. Receiving the CE Mark and ISO 13485:2016 certification will allow us to work with new physicians and hospital customers in Europe and other countries with our patented Nimbus technology for treating patients suffering from chronic pain,” CEO Bret Boudousquie said in a news release. “Nimbus provides a clinical solution for what matters most to our customers: faster procedure times, lower cost and predictable pain relief for patients suffering with chronic pain from osteoarthritis.”