MAGNOLIA, Texas, June 23, 2021 /PRNewswire/ — Stratus™Medical, a company focused on advancing radiofrequency (RF) ablation treatment for chronic pain, announced today it received CE Mark (Conformité Européenne) for Nimbus®RF Multitined Expandable Electrode and Vesta™ RF Cannula. The CE Mark confirms Stratus Medical, manufacturer of Nimbus and Vesta, meets the requirements of the European Medical Devices Directive, which allows Stratus Medical to commercialize Nimbus and Vesta across the European Economic Area and other countries that recognize CE Mark.
CE Mark issued to Stratus Medical, manufacturer of Nimbus and Vesta
Earlier this year, Stratus Medical received ISO 134385:2016 certification of its quality management system after completion of an audit by GMED, an international notified body in the certification of health care and medical device quality management systems. This certification, used by organizations involved in the design, production, installation, and servicing of medical devices, demonstrates the company’s focus on quality and its ability to provide medical devices that consistently meet both customer and applicable regulatory requirements.
Commenting on these significant company milestones, Bret Boudousquie, CEO, 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.”
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. The Nimbus® RF Multitined Expandable Electrode addresses the unmet need for an easy-to-use and cost-effective radiofrequency ablation device that provides a large-volume lesion for sustained pain relief. Stratus Medical is headquartered in Magnolia, Texas.
SOURCE Stratus Medical