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Telectronics Pty Ltd was an Australian company best known for its role in developing the
pacemaker An artificial cardiac pacemaker (or artificial pacemaker, so as not to be confused with the natural cardiac pacemaker) or pacemaker is a medical device that generates electrical impulses delivered by electrodes to the chambers of the heart ei ...
. It was located in Lane Cove, Sydney. In 1988 the business was acquired by
Pacific Dunlop Pacific Dunlop was a highly diversified Australian conglomerate company that operated in, among other things, the Automotive, textile, electronics and biotechnology industries. Products commercialised included tires, car batteries, cables, clot ...
. and also However, legal claims resulting from the sale of faulty pacemaker electrode leads inherited by the company in acquisition of Cordis Corporation of Miami led to eventual sale of the assets of the company and Pacific Dunlop restructuring itself into Ansell.


Development of the pacemaker

Telectronics Pty Limited was incorporated in Sydney, Australia, in 1963"Telectronics and The History Of Pacemaking In Australia", Wickham G G, Jeffcoat KW, 1987 manuscript held by http://www.austehc.unimelb.edu.au. University Of Melbourne .(www.austehc.unimelb.edu.au.) by technician and initial financier
Noel Gray Noel Desmond Gray (26 December 1920 – November 1999) Senior design engineer at the Philips subsidiary Kriesler and medical student at the University of Sydney after War service in the Royal Australian Electrical and Mechanical Engineers. He ...
and engineer
Geoffrey Wickham Geoffrey Gordon Wickham (born 28 October 1933) is one of the pioneers of cardiac pacemaking. He was born in 1933 in Camperdown, Victoria, Australia to dairy farmer parents. In 1963 he co-founded the medical instruments company Telectronics P ...
initially designing and manufacturing industrial and scientific instruments but diversifying into medical electronics and commencing cardiac pacemaker research in 1964. The corporate name was derived from "Television and Electronic Services", operated by Noel Gray as a sole trader from 1959 to 1964. The company made significant contributions to pacemaker technology including the first definition of the relationship between surface area of the heart electrodes & pacing pulse characteristics, the first use of
integrated circuits An integrated circuit or monolithic integrated circuit (also referred to as an IC, a chip, or a microchip) is a set of electronic circuits on one small flat piece (or "chip") of semiconductor material, usually silicon. Transistor count, Large ...
and the first
hermetic Hermetic or related forms may refer to: * of or related to the ancient Greek Olympian god Hermes * of or related to Hermes Trismegistus, a legendary Hellenistic figure based on the Greek god Hermes and the Egyptian god Thoth ** , the ancient and m ...
titanium Titanium is a chemical element with the Symbol (chemistry), symbol Ti and atomic number 22. Found in nature only as an oxide, it can be reduced to produce a lustrous transition metal with a silver color, low density, and high strength, resista ...
encapsulation. The company's first model, designated P1, was implanted in three
volunteer Volunteering is a voluntary act of an individual or group freely giving time and labor for community service. Many volunteers are specifically trained in the areas they work, such as medicine, education, or emergency rescue. Others serve ...
terminally ill Terminal illness or end-stage disease is a disease that cannot be cured or adequately treated and is expected to result in the death of the patient. This term is more commonly used for progressive diseases such as cancer, dementia or advanced he ...
patients in December '64 - January'65, while 2 control samples were retained in a 37 °C. saline bath. This initial design used PNP - NPN electronics to deliver a 2.0
millisecond A millisecond (from '' milli-'' and second; symbol: ms) is a unit of time in the International System of Units (SI) equal to one thousandth (0.001 or 10−3 or 1/1000) of a second and to 1000 microseconds. A unit of 10 milliseconds may be ca ...
pulse to the Jeffcoat
epicardial The pericardium, also called pericardial sac, is a double-walled sac containing the heart and the roots of the great vessels. It has two layers, an outer layer made of strong connective tissue (fibrous pericardium), and an inner layer made of ...
electrodes An electrode is an electrical conductor used to make contact with a nonmetallic part of a circuit (e.g. a semiconductor, an electrolyte, a vacuum or air). Electrodes are essential parts of batteries that can consist of a variety of materials dep ...
, and was powered by 4 Mallory mercuric oxide-zinc cells (
mercury battery A mercury battery (also called mercuric oxide battery, mercury cell, button cell, or Ruben-Mallory) is a non-rechargeable electrochemical battery, a primary cell. Mercury batteries use a reaction between mercuric oxide and zinc electrodes in an ...
), all encapsulated in
epoxy Epoxy is the family of basic components or Curing (chemistry), cured end products of epoxy resins. Epoxy resins, also known as polyepoxides, are a class of reactive prepolymers and polymers which contain epoxide groups. The epoxide functional ...
resin with a final dip coat of a mix of epoxy and
titanium dioxide Titanium dioxide, also known as titanium(IV) oxide or titania , is the inorganic compound with the chemical formula . When used as a pigment, it is called titanium white, Pigment White 6 (PW6), or CI 77891. It is a white solid that is insoluble ...
. All 3 implants failed in ability to maintain capture of the heart after periods of up to 35 weeks. These failures were later proven to be due to the excessively large surface area of the electrodes. The initial clinical experience led to further
animal research Animal testing, also known as animal experimentation, animal research, and ''in vivo'' testing, is the use of non-human animals in experiments that seek to control the variables that affect the behavior or biological system under study. This ...
using
mongrel A mongrel, mutt or mixed-breed dog is a dog that does not belong to one officially recognized breed and including those that are the result of intentional breeding. Although the term ''mixed-breed dog'' is sometimes preferred, many mong ...
dogs at the laboratories of the
University of Sydney The University of Sydney (USYD), also known as Sydney University, or informally Sydney Uni, is a public university, public research university located in Sydney, Australia. Founded in 1850, it is the oldest university in Australia and is one o ...
medical school and at the
Royal North Shore Hospital The Royal North Shore Hospital (RNSH) is a major public teaching hospital in Sydney, Australia, located in St Leonards. It serves as a teaching hospital for Sydney Medical School at the University of Sydney and has over 600 beds. It is the p ...
's Wellcome laboratory. In this research measurements were made of electrode impedance and pacing threshold energy over a range of pulse voltages and pulse widths, using intramyocardial electrodes of 10, 20 & 50 square millimeters surface area. The chronic measurements allowed plotting of the relationship between electrode surface area and pulse voltage/width, leading to a conclusion that an electrode area between 10 & 30 mm2 was optimum in terms of energy needed when combined with a pulse width of only 0.5 milliseconds. These characteristics were incorporated in the next design to be implanted in humans, the model P4, which employed 30 mm2 area intramyocardial electrodes (and later
transvenous pacing Transvenous cardiac pacing (TVP), also called endocardial pacing, is a potentially life-saving intervention used primarily to correct profound bradycardia. It can be used to treat symptomatic bradycardias that do not respond to transcutaneous paci ...
electrodes), a very conservative 7.5 volt pulse and for further conservatism a magnetically operated switch which could be actuated from outside the body to change the pulse width from 0.5 to 1.0 millisecond.
The 0.5 millisecond pulse width became the standard for later Telectronics models and became the approximate standard for all pacemaker manufacturers by the late 70's, until the evolution of externally programmable/monitorable pacemakers using
digital electronics Digital electronics is a field of electronics involving the study of digital signals and the engineering of devices that use or produce them. This is in contrast to analog electronics and analog signals. Digital electronic circuits are usual ...
in the late 1980s. Research also included
dissection Dissection (from Latin ' "to cut to pieces"; also called anatomization) is the dismembering of the body of a deceased animal or plant to study its anatomical structure. Autopsy is used in pathology and forensic medicine to determine the cause ...
and
analysis Analysis ( : analyses) is the process of breaking a complex topic or substance into smaller parts in order to gain a better understanding of it. The technique has been applied in the study of mathematics and logic since before Aristotle (3 ...
of the failure modes of explanted pacemakers of any manufacturer. Most failures were due to an internal short circuit of one of the cells of the multicell battery due to the growth of
metal A metal (from Greek μέταλλον ''métallon'', "mine, quarry, metal") is a material that, when freshly prepared, polished, or fractured, shows a lustrous appearance, and conducts electricity and heat relatively well. Metals are typi ...
lic
dendrites Dendrites (from Greek δένδρον ''déndron'', "tree"), also dendrons, are branched protoplasmic extensions of a nerve cell that propagate the electrochemical stimulation received from other neural cells to the cell body, or soma, of the ...
; or the result of
water vapour (99.9839 °C) , - , Boiling point , , - , specific gas constant , 461.5 J/( kg·K) , - , Heat of vaporization , 2.27 MJ/kg , - , Heat capacity , 1.864 kJ/(kg·K) Water vapor, water vapour or aqueous vapor is the gaseous ph ...
diffusing though the
epoxy resin Epoxy is the family of basic components or cured end products of epoxy resins. Epoxy resins, also known as polyepoxides, are a class of reactive prepolymers and polymers which contain epoxide groups. The epoxide functional group is also col ...
encapsulation.Cartmill T B, Wickham G G, "The Water Vapour Permeability Of Implantable Cardiac Pacemakers", Med J. Aust., 2:138, 1971. The only suitable cell available at the time was the mercuric oxide-zinc cell, so the battery problems remained. In 1967 Telectronics commenced research into the technologies which could allow
hermetic seal A hermetic seal is any type of sealing that makes a given object airtight (preventing the passage of air, oxygen, or other gases). The term originally applied to airtight glass containers, but as technology advanced it applied to a larger categor ...
ing of the pacemaker to preclude water vapour penetration and, as an interim measure contracted AWM a subsidiary of Amalgamated Wireless Australia Limited (
AWA Awa (or variants) may refer to: People * Awa (given name), notable people named Awa or Hawa * Awá (Brazil), an indigenous people of Brazil * Awa-Kwaiker, an indigenous people of Colombia and Ecuador Languages * Awa language (China) or Wa (Va) ...
) to develop integrated circuits for the electronics. These early integrated circuits were developed by David R Money who later joined Telectronics and later still led development of the
cochlear implant A cochlear implant (CI) is a surgically implanted neuroprosthesis that provides a person who has moderate-to-profound sensorineural hearing loss with sound perception. With the help of therapy, cochlear implants may allow for improved speech und ...
for the profoundly deaf. The circuits were analogue type, housed in hermetically sealed ceramic military 'flat packs' with redundant double gold bonding of the terminations. The IC's were first used in the model P7 of 1969. The first hermetically sealed models were the P8-9-10 of 1971Wickham G G, Cowdery D J, " An Hermetically Sealed Implantable Cardiac pacemaker", Proceedings of the 9th International Conference On Medical & Biological Engineering, Melbourne, 1971 using
titanium Titanium is a chemical element with the Symbol (chemistry), symbol Ti and atomic number 22. Found in nature only as an oxide, it can be reduced to produce a lustrous transition metal with a silver color, low density, and high strength, resista ...
encapsulation with
ceramic A ceramic is any of the various hard, brittle, heat-resistant and corrosion-resistant materials made by shaping and then firing an inorganic, nonmetallic material, such as clay, at a high temperature. Common examples are earthenware, porcelai ...
terminal insulation, developed by David J Cowdery. Bonding of the ceramic was performed using
vacuum A vacuum is a space devoid of matter. The word is derived from the Latin adjective ''vacuus'' for "vacant" or " void". An approximation to such vacuum is a region with a gaseous pressure much less than atmospheric pressure. Physicists often di ...
brazing Brazing is a metal-joining process in which two or more metal items are joined together by melting and flowing a filler metal into the joint, with the filler metal having a lower melting point than the adjoining metal. Brazing differs from w ...
and an alloy of titanium/nickel with a small percentage of copper. The final hermetic sealing of the titanium capsule was performed by a TIG
argon Argon is a chemical element with the symbol Ar and atomic number 18. It is in group 18 of the periodic table and is a noble gas. Argon is the third-most abundant gas in Earth's atmosphere, at 0.934% (9340 ppmv). It is more than twice as a ...
welding Welding is a fabrication process that joins materials, usually metals or thermoplastics, by using high heat to melt the parts together and allowing them to cool, causing fusion. Welding is distinct from lower temperature techniques such as br ...
process within a large
bell jar A bell jar is a glass jar, similar in shape to a bell (instrument), bell (i.e. in its best-known form it is open at the bottom, while its top and sides together are a single piece), and can be manufactured from a variety of materials (ranging fr ...
on an automated analogue controlled machine designed and built by Cowdery. These were the first pacemakers using the conventional battery to be hermetically sealed. Gas products of the battery were absorbed by a chemical 'getter'. Some examples of these models survived to beyond 5 years. By the late 80's TIG welding was replaced by
laser welding Laser beam welding (LBW) is a welding technique used to join pieces of metal or thermoplastics through the use of a laser. The beam provides a concentrated heat source, allowing for narrow, deep welds and high welding rates. The process is frequen ...
. In 1971 Telectronics commenced testing samples of a new type of energy source for pacemakers, the lithium cell (
lithium battery Lithium battery may refer to: * Lithium metal battery, a non-rechargeable battery with lithium as an anode ** Rechargeable lithium metal battery, a rechargeable counterpart to the lithium metal battery * Lithium-ion battery, a rechargeable bat ...
) being developed by
Wilson Greatbatch Wilson Greatbatch (September 6, 1919 – September 27, 2011) was an American engineer and pioneering inventor. He held more than 325 patents and was a member of the National Inventors Hall of Fame and a recipient of the Lemelson–MIT Priz ...
and in 1972 commenced development of a range of integrated circuits capable of operation from the 2.8 volts of the cell while providing a stimulating pulse of 4.5 volts. The combined technologies of a lithium cell, integrated circuits, hermetic titanium casing and an 0.5 millisecond pulse was first used clinically in 1974 in the model 120 pacemaker which was
state of the art The state of the art (sometimes cutting edge or leading edge) refers to the highest level of general development, as of a device, technique, or scientific field achieved at a particular time. However, in some contexts it can also refer to a level ...
for that time. In 1981 a study of 28,669 Telectronics lithium powered implants showed a cumulative survival of 99.88% and a
MTTF Mean time between failures (MTBF) is the predicted elapsed time between inherent failures of a mechanical or electronic system during normal system operation. MTBF can be calculated as the arithmetic mean (average) time between failures of a system ...
of 12,260 months.Telectronics publication "QRS", July 1981. The longest surviving model 120 was electively explanted in 1993 after 17 years of operation. Control of Telectronics was gained in 1967 by Nucleus Holdings. Telectronics Inc. was incorporated in the US in 1974, and in 1977 commenced US manufacture from the former
General Electric General Electric Company (GE) is an American multinational conglomerate founded in 1892, and incorporated in New York state and headquartered in Boston. The company operated in sectors including healthcare, aviation, power, renewable energ ...
facility in
Milwaukee Milwaukee ( ), officially the City of Milwaukee, is both the most populous and most densely populated city in the U.S. state of Wisconsin and the county seat of Milwaukee County, Wisconsin, Milwaukee County. With a population of 577,222 at th ...
, later relocating to
Denver Denver () is a consolidated city and county, the capital, and most populous city of the U.S. state of Colorado. Its population was 715,522 at the 2020 census, a 19.22% increase since 2010. It is the 19th-most populous city in the United ...
. A manufacturing plant was also established at
Châtellerault Châtellerault (; Poitevin-Saintongeais: ''Châteulrô/Chateleràud''; oc, Chastelairaud) is a commune in the Vienne department in the Nouvelle-Aquitaine region in France. It is located in the northeast of the former province Poitou, and the ...
France, in 1978.


Pacific Dunlop

In 1988
Nucleus Limited Nucleus Limited began as a private company in Sydney, Australia, in 1965. It was founded by former Watson-Victor executive Paul Murray Trainor, after acquisition of X-ray sales & service company Scientific & General. Other companies to be controll ...
was acquired by Pacific Dunlop. At that time Nucleus Limited contained offshoots such as Telectronics, Medtel, Ausonics, Domedica and Cochlear Pty Ltd. Cochlear Limited which developed the
cochlear implant A cochlear implant (CI) is a surgically implanted neuroprosthesis that provides a person who has moderate-to-profound sensorineural hearing loss with sound perception. With the help of therapy, cochlear implants may allow for improved speech und ...
was floated on the Australian stock market. Pacific Dunlop was hoping to diversify away from so-called rustbelt companies. At the time of acquisition, Telectronics was number 2 in the worldwide pacemaker market. In January 1995, Telectronics was forced to recall thousands of model 801 atrial "J" leads by the
Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food ...
leading to the company having to eventually settle legal claims at a cost of hundreds of millions of dollars. The cause of the recall was a "J lead" electrode, utilizing a rigid stylet within the helix of the electrode lead, inherited by the company in acquisition of pacemaker lead manufacturer Cordis Corporation of Miami. The inherent dangers arising from incorporation of a rigid stylet had been demonstrated by Telectronics, Sydney, in 1967. In 1996 Pacific Dunlop sold most of the assets of Telectronics Limited to
St Jude Medical St. Jude Medical, Inc. was an American global medical device company headquartered in Little Canada, Minnesota, U.S., a suburb of Saint Paul. The company had more than 20 principal operations and manufacturing facilities worldwide with products s ...
of
Minnesota Minnesota () is a state in the upper midwestern region of the United States. It is the 12th largest U.S. state in area and the List of U.S. states and territories by population, 22nd most populous, with over 5.75 million residents. Minne ...
and Telectronics Pty Limited is now a shelf company TPLC Pty. Ltd. Pacific Dunlop restructured in 2001 becoming
Ansell Ansell is an Australian company which manufactures protective industrial and medical gloves. It was previously well known as a condom manufacturer but sold that division in 2017. History Early years Ansell was formed as Dunlop Pneumatic Ty ...
with the high cost of the Telectronics settlement being a contributing factor in the decision.


References

{{reflist Defunct manufacturing companies of Australia Electronics companies of Australia Australian companies established in 1963