Nimbus RF electrode serve as radiofrequency ablation device to deliver a large-volume lesion for sustained pain relief
The approval enables the commercialisation of Nimbus and Vesta products across the European Economic Area. (Credit: Jai79 from Pixabay)
US-based medical device company Stratus Medical has secured CE mark approval for its Nimbus radio frequency (RF) multitined expandable electrode and Vesta RF cannula.
The approval enables Stratus Medical to commercialise Nimbus and Vesta products across the European Economic Area and other countries that accept CE mark.
The Nimbus RF multitined expandable electrode has been developed to serve as an easy-to-use radiofrequency ablation device to deliver a large-volume lesion for sustained pain relief.
Stratus Medical’s multitined expandable electrode has the potential to create a large 8mm-10mm prolate spheroid lesion for relief of pain.
In May, the company announced the enrollment of first patient in the EMERALD study, a level I, prospective, randomised control trial to compare the Nimbus RF multitined expandable electrode to conservative care.
Stratus Medical CEO Bret Boudousquie said: “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 physician and hospital customers in Europe and other countries with our patented Nimbus technology for treating patients suffering from chronic pain.
“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.”
Vesta is an advanced RF cannula, which includes an insulated cannula with an active tip for use in creating an RF heat lesion for the relief of pain.
The device features three components, including proximal hub, an insulated stainless steel cannula, and a distal stainless steel tip. Its active tip allows to transfer RF energy to the target tissue.
In July last year, the company received FDA clearance for the Vesta RF Cannula for use in radiofrequency heat lesion procedures for the relief of pain.