Implantable devices for treating pain (spinal cord stimulators and others)
Boston Scientific Received European Regulatory Approval For New Precision Spectra™ Spinal Cord Stimulator System. It is the first and so-far only SCS system with 32 contacts and 32 dedicated power sources designed to provide pain relief to a broad spectrum of chronic pain patients.
Image Source: Nevro's Website
Nevro Corp announced that FDA has granted approval for initiation of its SENZA-RCT study, a U.S. prospective, randomized, controlled pivotal clinical trial evaluating the safety and efficacy of Nevro’s high-frequency spinal cord stimulation system for the treatment of chronic pain.
Neuromed TIME IPG on loan from Daniel Villamil's collection.
Neuromed was formed in 1980 with an initial capitalization of $150,000 by Bill Borkan through money obtained when Borkan`s parents took out a second mortgage on their home. Borkan’s desire to help his sister, Jennie, a cerebral palsy patient, got him started in neurostimulation technology. In the next few years, Neuromed developed and marketed a RF-powered implantable spinal cord stimulator, along with its external radio frequency transmitter.
Throughout the 1980s, development of more advanced devices was ongoing at Neuromed. My friend Daniel Villamil from CCC Medical has in his collection one of these more modern units, which he lent to me for photographing. The “Total Implantable Multichannel Electronics” (TIME) spinal cord stimulator shown in this picture went into clinical trials around 1988. This was a device that was internally powered by its own battery. However, it could also be RF-powered after the eventual battery failure. Continue reading
In 2005, St. Jude Medical purchased Advanced Neuromodulation Systems (ANS) in Plano, Texas. ANS had developed a number of spinal cord stimulation IPGs that were either externally powered via inductive link, internally powered by a primary cell, or internally powered by a transcutaneously rechargeable lithium-ion cell.
Today, the most popular St. Jude spinal cord stimulators are the rechargeable 42 cc Eon and 18 cc Eon mini neurostimulators.
They are constant-current devices with a rated longevity of 10 years. Current through up to 16 electrodes is programmable between 0-25.5 mA with a pulse width of 50-500 µs and a frequency between 2-1200 Hz. Continue reading
NDI Medical was founded in 2002 by Geoffrey B. Thrope to develop and commercialize neurodevice products. NDI Medical developed the MicroPulse neurostimulator, a thumb-sized, rechargeable pulse generator, that has been used for the treatment of incontinence and pain, as well as an implantable device for the restoration of function of paralyzed limbs.
According to a 2006 news release by the electronics assembly manufacturer for the MicroPulse:
“Using minimally-invasive surgery, the Micropulse is implanted into a patient, usually in the lower abdomen or buttock, where the device is most comfortable and least visible. After implantation, a clinician uses a wireless programmer to set the Micropulse’s stimulus parameter and timing patterns. The programmer, as well as the patient’s controller for the device, has a range of about three feet.
To recharge the device’s lithium-ion battery, the patient applies a recharging patch for several hours to the vicinity of the implant. The battery needs recharging from once a month to every few weeks.” Continue reading
Palyon Medical Corporation was founded in 2004 in New York, NY, but recently moved its operations to Santa Clarita, CA. Palyon is still operating stealthily.
Palyon is developing a programmable implantable drug delivery system (IDDS) which delivers targeted doses of pain medication directly to the spinal area for the treatment of chronic pain, spasticity and other neurological diseases. According to Luis Malave, the company’s CEO, “Due to its inherent flexibility as a delivery platform, the IDDS can be used to deliver therapeutics to treat both acute diseases, such as cancer, and chronic diseases including diabetes and multiple sclerosis.” Continue reading
Neuros Medical was founded by Jon J. Snyder in Cleveland, OH in 2008 to develop a neurostimulation therapy to alleviate chronic pain. The company’s Electrical Nerve Block™ technology is based on research done at Case Western Reserve University.
The company’s Nerve Block is an implantable device that delivers high-frequency stimulation to sensory nerves in the peripheral nervous system. Neuros’ aim is to stop a wide variety of chronic pain, including residual limb pain, chronic post surgical pain, and chronic migraine.
In November 2011 Neuros Medical announced that it has received IDE approval from the FDA to evaluate its technology for use in acute treatment of pain in the residual limb of amputees.
Company website: http://www.neurosmedical.com/
Click here for patents on Case Western University’s nerve blocking technology
Spinal Modulation was founded by Mir Imran in Menlo Park, CA in 2004. The company has developed an implantable neurostimulator to deliver signals to the primary sensory neurons located within the dorsal root ganglion (DRG). The idea is that unlike dorsal column spinal cord stimulation, the Spinal Modulation system breaks the pain signal’s path before it enters the spinal cord. Continue reading
Nevro Corporation (formerly NBI Development) was founded in 2006 by Dr. Konstantinos Alataris. The Menlo Park, CA company developed a pain management concept that originated at the Mayo Clinic into a spinal cord stimulation system for back and leg pain.
According to Nevro, their unique stimulation waveform achieves pain relief without paresthesia or uncomfortable stimulation. Few details are available about the waveform, but Nevro’s Spanish distributor’s brochure specifies it as high-frequency stimulation at 10,000 Hz. This is consistent with Nevro’s patent applications which teach that “high-frequency modulation in the range of from about 1.5 KHz to about 50 KHz may be applied to the patient’s spinal cord region to address low back pain without creating unwanted sensory and/or motor side affects.” Continue reading
CCC is one of the oldest pacemaker manufacturers in the world. It was founded in 1969 by Dr. Orestes Fiandra, who performed the first succesful, human, long-term pacemaker implant in the world.This was achieved in Uruguay on February 2, 1960 by Dr. Orestes Fiandra and Dr. Roberto Rubio. The pacemaker was manufactured by Dr. Rune Elmqvist of Elema-Schönander in Sweden, and was implanted in Uruguay in a 34-year-old patient with AV block. This unit worked successfully for nine and a half months, until the patient died of sepsis from an unrelated infection. Continue reading
From US Patent Application Publication US 2009/0163889 A1
MicroTransponder was founded in Dallas, TX in 2007 when it licensed technology developed at University of Texas in Dallas (UTD) by Larry Cauller, who heads the cortical connections lab. The first wireless transponder was developed under a DARPA Revolutionizing Prosthetics grant to create a bi-directional neural interface for a prosthetic hand. Continue reading
Mir A. Imran (born 1956, Hyderabad, India), is an Indian entrepreneur and venture capitalist. Imran has formed 19 companies since the early 80s and holds over 140 patents. He is the founder and Chairman of InCube Laboratories, Inc., a research laboratory and business incubator for medical and technology companies
Currently, four InCube companies are focusing on active implantable medical devices:
Photo credits: Obtained from Spinal Modulation's site
Spinal Modulation is a company based in Menlo Park, CA. It has developed a neurostimulator for chronic intractable pain management.
According to the company, the Spinal Modulation System utilizes low-level electrical signals to modulate neural structures of primary sensory neurons located within the dorsal root ganglion (DRG). These cell bodies have been implicated in the development and maintenance of chronic pain conditions. Continue reading