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

Category Archives: Bluewind Medical

What happened to the BION®?

Posted on by Posted in Advanced Bionics, Alfred E. Mann, Axonics, Bluewind Medical, Boston Scientific, Electrode Materials, General Stim, Incontinence, Muscular Stimulation, Nalu, Neural Stimulation, Neuspera, Paralysis, University of Southern California, Valencia Technologies
RF-powered Bion stimulator

First-generation RF-powered BION (RFB1) microstimulator. Image Credit: Alfred Mann Institute for Biomedical Engineering

In 1991, Dr. Gerald Loeb, at the time a Professor of Physiology and Biomedical Engineering at Queen’s University (Kingston, Canada), first proposed a miniature, injectable, RF-powered device for the stimulation of tissue or motor neurons. The BION® device was developed based on this concept as a joint project between Queens University (Kingston, ON, Canada), IIT (Chicago, IL), and the Alfred E. Mann Foundation (Valencia, CA) with funding from the NIH Neural Prosthesis Program. The RF BION 1 (RFB1) was then manufactured by the Alfred Mann Institute for Biomedical Engineering at USC.

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The Bioelectronic Medicine Therapy Landscape

Posted on by Posted in Amber Therapeutics, Axonics, Bluewind Medical, Boomerang Medical, CVRx, Inspire Medical, Medipace Inc., Medtronic, Neuspera, Orchestra Biomedical, Respicardia, SetPoint Medical, Zoll
bioelectronic medicine therapies landscape

Image Credit: Victor Pikov, Ph.D., Medipace Inc.

Victor Pikov, Medipace’s founder and CEO, presented the OpenNerve Project at the First Workshop on Active Implantable Medical Devices last week.  As part of his excellent presentation, he discussed the current commercial landscape of bioelectronic medicine therapies.  A picture (in this case, the graph above) is worth a thousand words.

 

BlueWind Medical’s Revi System Tibial Neuromodulation System Approved by FDA

Posted on by Posted in Bluewind Medical, Incontinence, Neural Stimulation, Tibial Nerve Stimulation

Image Credit: Bluewind Medical

On August 17, 2023, the FDA authorized marketing for BlueWind Medical’s Revi System, a Tibial Neuromodulation System intended for use in the treatment of patients with symptoms of urgency incontinence alone or in combination with urinary urgency. The device consists of an active implantable wireless neurostimulation component intended to be placed in the vicinity of the tibial neurovascular bundle for peripheral nerve stimulation. Since the implant has no battery, the wearable unit transmits energy via magnetic coupling to the implant, which consequently generates electrical pulses stimulating the tibial nerve. These electrical pulses stimulate the nerve along the leg, reaching the sacral plexus and entering the spinal cord, relieving symptoms of urinary incontinence alone or in combination with urinary urgency.

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