Implantable Devices to treat specific conditions
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
TransWorld Heart Corporation of Charlotte, NC, was founded by Dr. Charles Richardson in 2004. The company developed an implantable device intended to replace routine post-transplant heart biopsies.
TransWorld’s Soul Mate implantable system analyzes 9 intramyocardial electrogram parameters recorded from 4 or 6 configurations of 2 or 3 epicardial leads to detect allograft rejection. Continue reading
It has been known for quite some time that bone growth is stimulated by DC electrical currents. However, only relatively recently implantable stimulators have been developed for the application.
In 1988 Biomet acquired Electrobiology Inc. (EBI) in Parsippany, NJ, a leader in bone-growth electrical stimulation and bone external fixation markets.
EBI’s OsteoGen™ Bone Growth Stimulator is marketed by Biomet Inc. It is designed for adjunctive use in the treatment of nonunions when surgery is required or when patient compliance is expected to be inadequate. The device is appropriate for any form of fracture. It is most often used on long bones and the clavicle. Variations of the OsteoGen device are available for high-risk fractures (OsteoGen™ Dual Lead Bone Growth Stimulator) and with mesh cathodes designed to provide scaffolding (OsteoGen™-M Bone Growth Stimulator). Continue reading
BioControl Medical, Ltd. was founded in 1999 by Yossi Gross, and is based in Yehud, Israel. BioControl’s first devices were developed to treat incontinence due to overactive bladder, stress, and interstitial cystitis. In 2006 American Medical Sytems acquired an exclusive license for the use of the technology in urology, gynaecology and other pelvic health applications.
The BioControl MiniatURO was an implantable muscle and nerve stimulator designed for subcutaneous implantation on an outpatient basis. Its purpose was to alleviate some types of urinary incontinence.
For patients suffering from stress incontinence, whenever the device detected an increase in abdominal pressure through its pressure-sensing catheter, it applied mild electrical pulses to the pelvic floor muscles. The intention was to activate the muscles and prevent inadvertent urine loss. In the urge incontinence mode of operation, the unit applied mild electrical pulses to the pelvic diaphragm nerve, using the sphincter detrusor muscle reflex to inhibit bladder contractions. For those with both types of incontinence, the two modes of operation were combined. In operation, the unit was intended to mimic natural physiology, activating the muscle upon demand, and strengthening the pelvic floor muscle. Continue reading
BioControl Medical, Ltd. was founded in 1999 by Yossi Gross, and is based in Yehud, Israel. BioControl’s first devices were developed to treat incontinence due to overactive bladder, stress, and interstitial cystitis. In 2006 American Medical Sytems acquired an exclusive license for the use of the technology in urology, gynecology and other pelvic health applications. Continue reading
Cameron Health was founded in 2000 in San Clemente, CA to develop a leadless implantable defibrillator.
The device does not require a lead to be implanted into the heart. Instead, the device has a lead that is tunneled beneath the skin from the upper left chest below the level of the clavicle to the level of about the breast, then tunneled laterally to the side of the chest beneath the arm. The device uses the subcutaneous lead to sense the heart rhythm and can detect rapid arrhythmias from the surface ECG created between the lead electrode and the can of the device. Its maximum shocking output is 80 joules. Continue reading
Medtronic announced at TEDMED 2010 that it is working on leadless pacemakers. Dr. Stephen Osterle, senior vice president of medicine and technology and member of Medtronic’s Executive Management Team, unveiled the device. Osterle said that physicians will be able to control the device with a smart phone.
EBR Systems, Inc., founded in 2003 and headquartered in Sunnyvale, CA, is developing the WiCS® Wireless Cardiac Stimulation technology to eliminate cardiac pacing leads, historically a major source of complications and reliability issues. The startup was spun out of research by founder Debra Echt, a former professor of medicine and a cardiologist at Vanderbilt University. Continue reading
Nanostim is an early-stage AIMD company in Milpitas, CA that is developing a pacemaker that can be implanted inside the heart through a catheter. The tiny device is attached directly to the heart, eliminating the need for leads.
In May 2011 Nanostim announced that St. Jude Medical had made a substantial investment in the company.
The company is operating in stealth mode, but some details about the leadless pacemaker have emerged from Nanostim’s patents and patent applications. An interesting detail is about the possible use of a betavoltaic power source: Continue reading
My friend, Dr. Alain Ripart – the Chief Scientific Officer at Ela Medical (now part of Sorin) showed me this interesting contraption from his personal collection. It is an experimental glucose-powered pacemaker developed in the 1970s. It generated electricity by acquiring its fuel (glucose) directly from a living body to generate enough current to charge two NiCd cells that powered the pacemaker. Continue reading
Barouh Berkovits at American Optical Co of Boston, MA designed the first “Demand Pacemaker” – what we now know as a VVI pacemaker. As other companies in the 1970s, American Optical developed a nuclear-battery-powered version of their pacemaker.
American Optical used a 3Ci Pu-238 Radioisotope Thermal Generator (RTG) produced by Fred Hittman’s Hittman Nuclear Development Corp. (Model NB-200). It consisted of a tiny 8 Ci slug of metallic Plutonium 238 (Pu-238). The radiation produced by the Pu-238 bombarded the walls of its container, producing heat that a thermopile then converted to an electrical current. A thermopile is a stack of thermocouples, which are devices that convert thermal energy directly into electrical energy using Seebeck effect. The thermocouple was made of two kinds of metal (or semiconductors) connected to each other in a closed loop. If the two junctions are at different temperatures, an electric current will flow in the loop. Continue reading
In the late 1960s Medtronic – today the largest manufacturer of implantable medical devices in the world – teamed up with Alcatel, a French company, to design a nuclear-powered pacemaker. The first human implant of the device took place in Paris in 1970.
The nuclear battery in the Medtronic device used a tiny 2.5 Ci slug of metallic Plutonium 238 (Pu-238). The radiation produced by the Pu-238 bombarded the walls of its container, producing heat that a thermopile then converted to an electrical current. A thermopile is a stack of thermocouples, which are devices that convert thermal energy directly into electrical energy using Seebeck effect. A thermocouple is made of two kinds of metal (or semiconductors) connected to each other in a closed loop. If the two junctions are at different temperatures, an electric current will flow in the loop. Continue reading
This nuclear pacemaker was manufactured ca. 1972 by Dr. Orestes Fiandra’s CCC del Uruguay. It was powered by a McDonell-Douglas Betacel 400 which had promethium-147 sandwiched between semiconductor wafers. As the radioactive promethium isotope decays, it emits β-particles (electrons). The impact of the β-particles on a p-n junction causes a forward bias in the semiconductor similar to what happens in a photovoltaic cell (a solar cell).
The Betacel 400 had an open-circuit voltage of 4.7V and a short circuit current of 115μA. The maximum power output was 370μW. CCC’s pacemaker was expected to last for 10 years when powered by this nuclear battery. Continue reading
Shree Pacetronix Ltd., was founded in Pithampur, Dist. Dhar, India in 1988. In 1993 the company was converted to a Public Limited Company. The company is listed on the Bombay Stock Exchange and regional exchanges.
Pacetronix’s website shows EC type certificates for its Pinnacle SSIR (model 297), Pinnacle SSI (model 8820), Charak DDD (model ND 747), and Akash VDD (model ND 244) pacemakers. Continue reading