Monday, September 16, 2019
Saluda Medical Pty Limited today announced the award of CE Mark and the European commercial launch of the Evoke® ECAP-Controlled, Closed-Loop Spinal Cord Stimulation (SCS) System for the treatment of chronic pain. The world's first commercial implants were completed in The Netherlands.
Evoke is the first closed-loop SCS system that measures the spinal cord's response to stimulation (via ECAPs, or evoked compound action potentials) and adjusts on every pulse to optimize activation within the patient's therapeutic window.
Dr. Harold Nijhuis, Anesthesiologist and Pain Management Consultant at St. Antonius Hospital, Nieuwegein, The Netherlands, the first commercial user of Evoke worldwide, stated, "We have been anticipating the launch of the Evoke System for some time and are delighted to be the first commercial users of this important new technology. Our team is dedicated to providing patients with the most impactful innovations to help manage their chronic pain and we are already seeing positive initial results with the Evoke System. For the first time we can directly measure each individual patient's neurophysiological response to SCS and use this objective data to guide how we program the system to best treat their individual pain complaint. This is a disruptive advance in the field of neuromodulation that will benefit a huge number of patients suffering with refractory pain conditions."
Last week at the European Pain Federation, EFIC 2019, Dr. Nijhuis was invited to present two posters that highlighted the clinical advantage of the ability to measure the spinal cord's response to stimulation. Nijhuis explained, "Without the ability to measure, we cannot overcome the variability of spinal cord activation. With Evoke SCS, we can set each patient's individual therapeutic window and let the device adjust on every pulse, millions of times per day, to meet their need."
John Parker, CEO of Saluda Medical, commented, "This is of course an important moment in the development of our organization, but it is also a key milestone for the field of neuromodulation as a whole. Evoke is the first and only ECAP-controlled, closed-loop SCS system which, after almost a decade in development, is now commercially available to clinicians to help them treat patients suffering with chronic pain. Our efforts are now focused on ensuring the excellent patient outcomes we have seen in our pre-market clinical studies are replicated, post-approval, in Europe, and scaling our business to meet the burgeoning demand for the Evoke System."
About Saluda Medical
Saluda Medical is a global medical device company focused on patient outcomes, science, and engineering to transform the neuromodulation industry with a platform of closed-loop technologies based on the evoked compound action potential (ECAP). Saluda's first device, Evoke®, is the first Closed-Loop Spinal Cord Stimulation (SCS) System. Evoke measures the spinal cord's response to stimulation (ECAP), adjusts on every pulse to optimize activation within the patient's therapeutic window, and maintains long-term results through ECAP control as demonstrated in the Avalon Study. In the EU, Evoke is CE Marked and commercially available. In the U.S., Evoke is currently under investigation through the first double-blinded, randomized, controlled U.S. pivotal study in SCS. Saluda is pursuing Australian TGA approval and U.S. FDA approval of Evoke; Evoke is not yet available for sale in these markets.
Saluda Medical is a privately-held company with headquarters in Artarmon, New South Wales, Australia and offices in Bloomington, MN, USA and Harrogate, UK. To learn more, visit www.saludamedical.com and connect with us on LinkedIn at www.linkedin.com/company/saluda-medical/.