Pacesetter Human Tissue Stimulator (HTS) (c) David Prutchi, Ph.D., 2024
I recently acquired this device on eBay® (from a very kind seller, I may add). Although labeled as a “Rechargeable Pacemaker,” and looks just like the one at the Udvar-Hazy about which I had posted a few years ago, it is in fact a neurostimulator.
The Human Tissue Stimulator or “HTS” was developed subsequently to the rechargeable pacemaker, prompted by the clinical need for a rechargeable implantable neurostimulator.
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.
Yesterday I visited the Udvar-Hazy Center of the Smithsonian Air & Space Museum in Chantilly, VA. There I found this demo rechargeable pacemaker being displayed as a spinoff of NASA’s technology with the following explanation:
I can’t remember exactly where I found the picture of a Pacesetter model BD102 VVI, but the story behind it is documented by Kirk Jeffrey in “Machines in our Hearts”:
“In 1968, Robert Fischell, of the Applied Physics LOaboratory at Johns Hopkins University, and cardiologist Kenneth B. Lewis had begun a collaboration that led in 1973 to a new kind of Ni-Cad battery able to function more effectively at body temperature and hermetically sealable. Alfred E. Mann, a California entrepreneur with background in the aerospace industry, had provided some financial support to the Hopkins group. Eventually Mann founded a small company to develop a pacemaker for the rechargeable battery; this was the origin of Pacesetter Systems. The rechargeable pacemaker reached the market in the summer of 1973, just as CPI introduced its lithium pacer.”
On February 4, 2013, after more than 20 years of research and development, Second Sight Medical Products, Inc., announced that its Argus® II Retinal Prosthesis System (“Argus II”) has received U.S. market approval from the Food and Drug Administration (FDA) to treat individuals with late stage retinitis pigmentosa (RP). This announcement follows receipt of the European approval in 2011, and a unanimous recommendation by the FDA’s Ophthalmic Devices Advisory Panel in September 2012 that this revolutionary product be made available to treat this patient population in the U.S.
Second Sight Medical Products, Inc., located in Los Angeles, CA, was founded in 1998 by Alfred Mann to develop a retinal prosthesis to provide sight to patients blinded from outer retinal degenerations, such as Retinitis Pigmentosa.
Second Sight’s Argus II Retinal Prosthesis System is intended to provide electrical stimulation of the retina to induce visual perception in blind individuals. The implant is an epiretinal prosthesis surgically implanted in and on the eye that includes an antenna, an electronics case, and an electrode array. The external equipment includes glasses, a video processing unit (VPU) and a cable.
Alfred E. Mann holds B.A. and M.S. degrees in physics from the University of California, Los Angeles and honorary doctorate degrees from the University of Southern California, The Johns Hopkins University, Western University and the Technion Institute (Israel), as well as, Research Professor, University of Southern California, and Adjunct Professor, Dept. of Bioengineering, University of California Los Angeles.
Alfred Mann has founded 17 companies in his career. The AIMD companies currently within his control are: