A blog about what is new (and old) in the world of active implantable medical devices

Category Archives: Saluda Medical

Saluda’s Evoke Spinal Cord Stimulation Received FDA Approval (Feb 2022)

Posted on by Posted in Neural Stimulation, Pain, Saluda Medical, Spinal Cord Stimulation
Saluda Medical Evoke IPG

Image Credit: Saluda Medical

In February 2022 FDA approved Saluds Medical’s Evoke® Spinal Cord Stimulation (SCS) System (Evoke System), which is an implanted, rechargeable spinal cord stimulation system intended to treat chronic, intractable pain in the trunk or limbs.

The Evoke® System automatically adjusts stimulation to maintain precise and consistent neural activation with breathing, coughing, positional changes and activity to keep a patient at their prescribed stimulation dose. Continue reading→

Saluda Medical’s Closed-Loop Evoke SCS Device for Pain

Posted on by Posted in Pain, Saluda Medical, Spinal Cord Stimulation

Image credit: Saluda Medical

Back in 2013 I reported that Sydney, Australia-based Saluda Medical had started the development of a closed-loop SCS system for pain.

Since then, Saluda has gone through a number of financing rounds, the latest being all-equity $40M from Action Potential Venture Capital (APVC, a GSK fund that invests in companies developing bioelectronic medicines) and Medtronic.

Saluda’s rechargeable Evoke Spinal Cord Stimulator is meant to detect the neural signals evoked by the stimulation system to maintain effective stimulation levels. The idea is that based on the evoked-potential feedback, as well as its knowledge of the user’s preferences, will allow the system to personalize therapy for optimal response against pain.

Saluda has presented long-term clinical data from its first chronic implant study, which was conducted in Australia. According to the presented results, at 6 months, subjects with axial back pain experienced an average sustained improvement of 80% relief. In addition, the 32-patient cohort showed clinically meaningful improvements in function, disability, and sleep.

Saluda Medical’s website: https://www.saludamedical.com

Sydney-based Saluda Medical Developing Closed-Loop SCS System for Pain

Posted on by Posted in Pain, Saluda Medical, Spinal Cord Stimulation

Saluda_MedicalStart-up company Saluda Medical has been awarded $5M by Australia’s New South Wales Government to support the development of a closed-loop spinal cord stimulation system for the treatment of pain.

The difference between other SCS systems and Saluda Medical’s is that the latter – the Implanted Neural Sensing & Stimulation product (INS2) – is that it both stimulates and senses nerve responses.

Saluda was spun out of NICTA – Australia’s largest publicly-funded information and communications technology research organization – earlier this year after successfully raising an initial $5M in private investment.  A new $5M grant was provided to Saluda from the inaugural round of the NSW Government’s Medical Devices Fund (MDF), a competitive technology development and commercialization program funded by the NSW Government through the NSW Ministry of Health.

 An excellent technical/business presentation video on the INS2 is available at: http://www.onemedplace.com/database/list/cid/14611/