Implantable devices for the treatment of bradycardia (pacemakers)
The Circadia pacemaker was one of the very few devices that had a lead-borne thermistor to measure cental venous temperature (CVT) as a sensor for rate-response.
A unique feature of this pacemaker was an iridium-oxide (IrOx)-coated button welded to the can. It was believed that this button would improve unipolar IEGM sensing and reduce unipolar pacing thresholds (it didn’t). Continue reading
One of the indicators of metabolic demand that has been used for controlling the rate of pacemakers is central venous blood temperature (CVT).
In 1983, Bill Cook and Dr. Neal Fearnot began to work under the Cook Pacemaker Company on developing the technology developed by Dr. Fearnot at Purdue University into an improved prototype for a temperature-based exercise responsive pacemaker that was released in 1988 as the Kelvin Sensor rate-responsive pacemaker. One of the first CVT rate-adaptive pacemakers was the Cook Model Kelvin 500 series.
Another one of the first CVT rate-adaptive pacemakers was the Intermedics Nova MR, which differs from the Kelvin 500 series in that its pacing algorithm had a more dynamic HR response. Continue reading
Medcor was established in Hollywood, FL in 1969, and began developing pacemakers, lead and accessories in 1971. By 1975 it had a series of lithium-powered pacemaker in the market, but they never became popular with physicians.
On July 1980, Daig Corporation of Minnetonka, MN acquired Medcor with the expectation that Medcor pacemaker technology could be profitably marketed.
Daig had hoped to market a new line of Medcor pacemakers, but significant electronic malfunctions were encountered which foreclosed further development Medcor’s pacemaker product line. As a result of malfunctions in the first pacemaker line, FDA approval was withheld on a second Medcor line of pacemakers due to similarities in product design.
In 1981, amidst a very serious financial condition, Daig closed its doors. The remaining assets were acquired by Daig’s largest customer – Pacesetter (now part of St. Jude Medical).
UPDATE, May 20, 2013:
Mark Christensen – who worked at Daig Corporation from 1980 to 1986 – sent me a kind note with some additional information: “As you note in your comments on Medcor, it was purchased by Daig in 1980 but remained as a separate business. Daig’s financial crisis in 1981 caused Daig to go into Chapter 11 Bankruptcy and Medcor went to Chapter 7 – liquidation and was sold at auction in late 1981. No pacemaker company bought any of the assets. Daig reorganized, diversified into EP catheters and was bought by St Jude Medical in 1996 (15 years later).” Thanks Mark!
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
This is one of my most prized possessions. It is one of the very first pacemakers produced by CCC del Uruguay in 1969. It was given to me by my friend, the late Dr. Orestes Fiandra, founder of CCC del Uruguay.
On February 2, 1960, Dr. Orestes Fiandra and Dr. Roberto Rubio accomplished the first succesful long-term human implant of a pacemaker. 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.
In 1969, Dr. Fiandra started the “Centro de Construccion de Cardioestimuladores del Uruguay” (CCC for short) with the purpose of producing pacemakers for use in Latin America at prices well under those of American devices. The device in the photograph above is one of these devices – a simple VOO pacemaker powered by 5 mercury cells encapsulated in epoxy resin.
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
Omikron Scientific was a small-scale pacemaker company founded in Rehovot, Israel in 1979. The company stopped pacemaker production in 1985.
Besides pacemakers, Omikron also produced a skin substitute called Omniderm, which was a thin, transparent, flexible membrane. It was used when a biological dressing would otherwise have been used.
Omikron’s pacemakers were all VVI and featured gradual decline Magnet Rate & Programmed Rate. Models included the 811 (6.5 year longevity), 811L (10 year longevity), 811XL (14 year longevity), 821 (VVIM with 8 year longevity), 837, a 838 (6.5 year longevity).
Click here for Omikron’s patents.
Dr. Fischell received his BSME degree from Duke University and MS and Sc.D. degrees from the University of Maryland. Dr. Fischell was employed at the Johns Hopkins University where he was the Chief Engineer of the Space Department and worked on more than 50 spacecraft. His interests at Johns Hopkins then turned to the invention of new medical devices such as pacemakers and implantable heart defibrillators. Starting in 1969, Dr. Fischell began the formation of 14 private companies that licensed his patents on medical devices. These companies include Pacesetter Systems, Inc. (now called St. Jude Medical), IsoStent, Inc., NeuroPace, Inc., Neuralieve, Inc., Angel Medical Systems, Inc, and Svelte Medical Systems, Inc. Dr. Fischell is a prolific inventor with over 200 issued U.S. and foreign patents, many of which have been the basis for new medical device companies. Continue reading