A blog about what is new (and old) in the world of active implantable medical devices 

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TransWorld’s Soul Mate Implantable Heart Transplant Rejection Monitor

TransWorld Medical's Soul Mate Implantable Heart Transplant Rejection Monitor
Image Source: TransWorld Heart Corporation’s Website

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. Read more…

 
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Biomet EBI’s OsteoGen™ Implantable Bone-Growth Stimulator

Electrobiology Inc (EBI) Osteogen Implantable Bone-Growth StimulatorIt 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). Read more…

 
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BioControl’s MiniatURO Muscle Stimulator to Alleviate Incontinence (1999-2006)

BioControl's MiniatURO implantable muscle stimulator for the treatment of incontinenceBioControl 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. Read more…

 
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BioControl’s CardioFit System for the Treatment of Heart Failure via Vagus Nerve Stimulation

Biocontrol's Cardiofit Vagus Nerve Stimulator for Heart Failure Treatment

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. Read more…

 
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Cameron Health’s Leadless Implantable Defibrillator

Cameron Health's subcutaneous defibrillatorCameron 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. Read more…

 
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Medtronic’s Leadless Pacemakers

Medtronic's Leadless Pacemaker

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.

Read more…

 
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EBR System’s Wireless Pacemaker

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. Read more…

 
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Nanostim’s Leadless Pacemaker

Nanostim's leadless pacemakerNanostim 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: Read more…

 
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BetaBatt’s Modern Betavoltaic Cells to Power Active Implantable Devices

Porous-silicon diode membrane being developed by BetaBatt for an implantable betavoltaic cell
Image Credit: University of Rochester

Nuclear energy cells that converted the impact of the β-particles on a p-n junction were developed in the 1970s.  One example was CCC’s atomic pacemaker, which was powered by a promethium-147  McDonell-Douglas Betacel 400.

Lately, BetaBatt Inc. of Houston, TX licensed beta-voltaic technology developed  at the University of Rochester to develop an implantable power source under the trade name DEC™ Cell, in which a silicon wafer captures electrons emitted by a radioactive gas such as tritium. The wafer is etched in a three-dimensional surface to capture more electrons.  The battery is sealed in a hermetic package  which  entirely  contains  the  low-energy  particles emitted by tritium, rendering the battery safe for long-term human  implant  from  a radiological-health standpoint.  Tri­tium has a half-life  of 12.3 years so that the technology  is more than adequate to meet the requirements of many implantable devices. Read more…

 
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Glucose Fuel-Cell-Powered Implantable Devices

Experimental glucose-powered fuel-cell pacemaker (1970s)

 

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. Read more…

 
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American Optical’s Nuclear Pacemaker (1970’s)

American Optical Nuclear Pacemaker

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. Read more…

 
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Arco Medical’s Nuclear-Powered Pacemaker (ca.1974)

Arco pacemaker powered by a plutonium 238 RTG

Image Credit: Arco Medical Products Co. (1974)

An isotopic thermoelectric generator was developed in the US by Numec Corporation under a contract from the US Atomic Energy Commission and sold for $3,200 (back in 1974). The thermopile consisted of doped bismuth telluride pairs that were placed in a parallel/series arrangement to generate some 300 μW of power to run this Arco Medical model NU-5F pacemaker. Read more…

 
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Medtronic’s Atomic Pacemaker (early 1970’s)

Medtronic's atomic pacemaker powered by an Alcatel plutonium 238 RTG

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. Read more…

 
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CCC del Uruguay’s Atomic Pacemaker (1972)

Promethium Betacell-Powered Atomic Pacemaker Manufactured by CCC in 1972

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. Read more…

 
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Indian Pacemaker Companies: Shree Pacetronix and MediVed

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. Read more…

 
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