by: Orestes Fiandra, MD Table of Contents
Introduction On February 3, 1960, in Montevideo, Uruguay, Orestes Fiandra MD and Roberto Rubio MD implanted the first pacemaker in the Western Hemisphere in a 40 year old woman with complete heart block and syncopal episodes. The pacemaker was an advanced version of the rechargeable pacemakers which had been implanted October 8, 1958 in Stockholm in a man. The Uruguayan implant operated for some nine months until the patient’s death. Chardack, Gage and Greatbatch implanted a pacemaker powered by primary (non-rechargeable) mercury zinc oxide batteries, in Buffalo, USA on June 6, 1960.
During the 1960s, few implantations were performed in Uruguay because of the extremely high costs of imported pacemakers. By 1969, in an attempt to solve the problem of cost, local production of pacemakers was begun by the Centro de Construccion de Cardioestimuladores del Uruguay (C.C.C.) founded by Dr. Fiandra. Initial production was difficult as pacemaker manufacture requires precision technology. without margin for error. As C.C.C. overcame these problems manufacture of high quality product became possible. Today, Uruguay is one of eight nations in which the ten pacemaker manufacturing facilities of the world are located. C.C.C. was the fourth manufacturer to use nuclear power in pacemakers and the sixth to use lithium batteries, the present universally used power source.
C.C.C. pacemakers are internationally acknowledged and were included in "The Pacemaker and Valve Identification Guide" compiled by Drs. Robert M. Steiner and Dryden Morse; and in "A Guide to Cardiac Pacemakers" by Drs. Morse, Steiner and Victor Parsonnet; as well as in the "Biomedical Business," all published in the USA. Dr. Thomas Preston, then Chief of the Cardiology Department of the Veterans Administration Hospital in Ann Arbor, Michigan, expressed, in November 16, 1974, his admiration for what C.C.C. had done: "…It was fascinating that you manufactured your own pacemakers in Montevideo." C.C.C. has been caring for the scientific, as well as the humanitarian aspects of pacemaker technology. Over the years C.C.C. has received letters requesting assistance from throughout Latin America and has supplied pacemakers for their medical requirements.
C.C.C. has contributed to the development of Cardiac Pacing. It was awarded the first "Great Prize" given by the Uruguayan Ministry of Education in 1978 for the results of its research concerning pacemakers and has four times received awards given by the Society of Medicine of Montevideo for its contribution to cardiac pacing research. More recently, in 1985, the book "Cardiac Pacemakers" published by C.C.C. was awarded the First Prize from the National Academy of Medicine in Uruguay.
C.C.C. at present produces the APEX and Argos pacemaker series; and LD PACE, a special stimulator for cardiomyoplasty; a neurological stimulator, with a peridural lead for pain control, the Optimizer II, a device created by Impulse Dynamics of Israel and USA, and manufactured by CCC, for Cardiac Contractility Modulation (CCM) in heart failure. All are programmed by a PC with a data base for patient identification and recording of all modifications to the patient’s pacemaker program and for generation of a medical report. The programmer also allows trans-telephonic follow-up and programming.
The C.C.C. industrial plant is located in a non-polluted area of Montevideo where manufacture is consistent with the QA System ISO 9001 and EN 46001.
C.C.C. exports pacemakers to Chile, Argentina, Paraguay, Bolivia, Colombia, Nicaragua, Iran, Cuba, Hungary, Greece, Jamaica, Venezuela, Peru, Bahamas and Italy.
First Long-Term Working Implantable Pacemaker | (insertimagehere) | - Date of Implant: February 3, 1960
- Implanted by: Orestes Fiandra, MD and Roberto Rubio, MD
- Location: Montevideo, URUGUAY
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Side View
| (insertimagehere) | - A) Internal coil (receiving charge)
- B) Anode (positive pole)
- C) Anode interruption to allow the charge transmitted through the coil of the charger to have access to the receiving coil placed inside the pacemaker
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Front View | (insertimagehere) | - Nickel Cadmium accumulators (rechargable batteries)
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Back View
| (insert image here) | - The circuit of the generator is visualized
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Electrode | (insertimage here) | - Myocardial side (Platinum)
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Electrode
Charger
| (insert image here) | - The charger and the pacemaker
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Historical Pacemakers from CCC | (insert image here) | - First pacemaker model manufactured by CCC
- The first unit was implanted in a human in April 1970
- VOO
- Bipolar
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7011 | (insert imagehere) | - VOO
- Model: 7011
- Bipolar
- This model was implanted from November 1970 until the end of 1973
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| (insert image here) | This pacemaker only ran off one group of batteries at any given moment. When that group became polarized and the voltage began to diminish the other group switched on. This would in turn let the polarization of the first group subside and allow the voltage of that group to rise back up. When the other group began to polarize the process would reverse. - VOO
- Bipolar
- With six mercuric batteries in two groups of three batteries each
- This pacemaker was implanted from 1974 until 1981
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Atomic Pacemaker (side A) | (insertimagehere) | - VOO
- Bipolar
- Plutonium beta cell battery
- Manufactured in 1974
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Atomic Pacemaker (side B) | (insert image here) | - VOO
- Bipolar
- Plutonium beta cell battery
- Manufactured in 1974
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Macrolito - VOO | (insert image here) | - VOO
- Model: Macrolitio
- Bipolar
- Manufactured in 1975 with a battery model 702 from Wilson Greatbatch Ltd (WGL).
- CCC was the sixth factory in the world to use Lithium batteries for pacemakers.
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Macrolito - VVI | (insertimage here) | - VVI
- Model: Macrolitio
- Bipolar
- Manufactured from 1975 until 1979
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Minilito - VVI | (insert imagehere) | - VVI
- Model: Minilitio
- Bipolar with Lithium battery and stainless steel 316 case
- The electronic components are included in solid epoxi resin
- Manufactured from 1979 until 1980
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Microlito | (insertimage here) | - VVI
- Model: Microlitio
- Monopolar
- Stainless steel case with hermetic soldering
- The electronic components are surrounded by inert gas
- Optative connector of 6 mm or 4.7 mm
- Manufactured in 1980.
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1080 | (insert imagehere) | - VVI
- Model: 8010
- Monopolar
- Lithium battery
- Titanium case hermetically soldered
- Inert gas inside
- Some units were programmable
- Manufactured from 1980 until 1983
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8307 | (insert image here) | - Pacemaker VVI
- Model: 8307
- Monopolar
- Hermetic titanium case
- Helium inside
- Manufactured from 1983 until 1993
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Present Pacemakers from CCC APEX 3143 | (insert image here) | - SSI
- Model Name: Apex 3143 (presently used)
- Multiprogrammable
- Mono-bipolar
- Manufactured since 1993
- Hermetic titanium case
- Lithium-Iodine battery from WGL.
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APEX 4000+ | (insertimagehere) | - Pacemaker DDD
- Model Name: Apex 4000+
- Multiprogrammable
- Mono-bipolar
- Manufactured since 1993
- Hermetic titanium case
- Lithium-Iodine battery from WGL.
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Argos 297 | (inesrtimage here) | - Pacemaker SSI-R
- Model Name: Argos 297
- Multiprogrammable
- Mono-bipolar
- Rate responsive (accelerometer)
- Hermetic titanium case
- Lithium-Iodine battery from WGL.
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LD-PACE II | (insert image here) | Pacemaker for cardiomioplasty - Model Name: LD-PACE II
- Multiprogrammable
- Mono-bipolar
- Hermetic titanium case
- Lithium-Iodine battery from WGL.
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COR-ART | (insert image here) | Pacemaker for implantable artificial heart actioned by the Lattissimus Dorsi - Model Name: Cor-Art
- Multiprogrammable
- Mono-bipolar
- Hermetic titanium case
- Lithium-Iodine battery from WGL.
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