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

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Functional Neuromodulation Ltd. Starts Study using DBS of the Fornix (DBS-f) for Mild Alzheimer’s

Medtronic Activa PC used by Functional Neurostimulation for treating Alzheimer'sToronto-based Functional Neuromodulation announced that it implanted the first U.S. Alzheimer’s patient in the “ADvance Study” with a deep brain stimulation (DBS) system meant to improve cognitive performance. ADvance will evaluate the safety and potential clinical benefit of DBS of the fornix (DBS-f), a major inflow and output pathway in the brain’s memory circuit, for patients with mild Alzheimer’s.  The ADvance Study is being conducted using Medtronic Activa DBS IPGs.

While DBS has been an effective treatment for movement disorders for more than 15 years, it was only recently that this approach was first applied to Alzheimer’s. Dr. Andres Lozano, a neurosurgeon at University of Toronto and Scientific Founder of Functional Neuromodulation, originated the concept of treating memory disorders using deep brain stimulation (DBS) while treating a patient suffering from morbid obesity. In this patient, DBS stimulation of the hypothalamus and fornix was associated with an unexpected observed improvement in the patient’s memory.

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Boston Scientific’s Precision Spectra™ SCS with 32 Contacts and 32 Dedicated Power Sources Receives CE Mark

Precision Spectra Spinal Cord Stimulator by Boston Scientific www.implantable-device.com  David Prutchi, Ph.D.

Boston Scientific Received European Regulatory Approval For New Precision Spectra™ Spinal Cord Stimulator System.  It is the first and so-far only SCS system with 32 contacts and 32 dedicated power sources designed to provide pain relief to a broad spectrum of chronic pain patients.

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Boston Scientific Defibrillators Receive CE Mark for 10-Year Longevity Projections

 

Boston Scientific Incepta ICD with DF-4 connector

Image Credit: Boston Scientific

Boston Scientific has received CE Mark approval for increased longevity projections for the INCEPTA™, ENERGEN™, PUNCTUA™, COGNIS® and TELIGEN® implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). The longevity projections are based on data submitted to the European authorities and vary for each device dependent on the model type and settings.

Projected device longevity exceeds 10 years for some models, approaches eight years for its CRT-D devices, and according to the press release is up to double that of comparable competitive device models. The company supports these devices with warranties of up to 10 years:

Warranties: INCEPTA and ENERGEN VR ICD: 10 years; INCEPTA and ENERGEN DR ICD: eight years; PUNCTUA and TELIGEN ICD: seven years; INCEPTA and ENERGEN CRT-D: six years; and PUNCTUA & COGNIS CRT-D: five years.

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RF Programming Hack Demonstrates Potentially Fatal ICD Exploit

I received today a link to a very interesting article which plays on the fears of the public, and which I am sure will result in tough new regulations to our industry.

The article discusses how IOActive researcher Barnaby Jack reverse-engineered a “pacemaker transmitter” (probably a programmer or a MICS module) to command ICDs within a 30 feet range to fire, or to rewrite their firmware.

This is the reason why MICS (“RF telemetry”) is under renewed scrutiny by regulators. Thoughts for mitigating this issue include requiring authentication and exchange of encryption keys via close-range (inductive) telemetry and other means before allowing any programming via MICS.

Click here for the original article.  The text reads:

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Boston Scientific’s Q3 2012 AIMD Results: CRM Dropped 6%, Neuromodulation Up 5%

Boston Scientific Logo

Today Boston Scientific reported its results for Q3 2012.  For its AIMD divisions:

Cardiac Rhythm Management sales dropped from $503M in Q3 of 2011 to $462M for this year (-8%), a 6% decrease on constant-currency basis.

Neuromodulation sales grew by 5% from $84M to $88M.

 
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Biotronik Launches Implantable BioMonitor for Monitoring Arrhythmias

Biotronik BioMonitor to diagnose arrhythmias.  David Prutchi PhD www.implantable-device.comBiotronik announced the European market release of BioMonitor®, an implantable cardiac device designed for the highly accurate and reliable monitoring and management of patients with atrial fibrillation (AF) or unexplained syncope.

According to Biotronik’s press release:

“BioMonitor® is a subcutaneous implantable leadless cardiac monitor for the long-term continuous remote monitoring of patients with arrhythmias such as AF, bradycardia, sudden rate drop, asystole and tachycardia.

As sensitivity and specificity are essential in the detection of arrhythmias such as AF, BIOTRONIK has developed ClearSense Technology with a unique three-vector signal detection that produces highly precise and reliable arrhythmia monitoring.

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St. Jude’s Q3 2012 AIMD Results: CRM Maintains Downward Trend, Neuromodulation Steady

St. Jude announced today its third quarter 2012 results.  From the press release:

“Total CRM sales, which include implantable cardioverter defibrillator (ICD) and pacemaker products, were $691 million for the third quarter of 2012, an 8 percent decrease compared with the third quarter of 2011. Total CRM sales for the third quarter decreased 4 percent after adjusting for the impact of foreign currency.

Of that total, ICD product sales were $412 million in the third quarter, a 7 percent decrease compared with the third quarter of 2011. On a constant currency basis, total ICD sales declined 4 percent from the prior year.

Third quarter pacemaker sales were $279 million, a 9 percent decrease compared to the third quarter of 2011. After adjusting for the impact of foreign currency, pacemaker sales decreased 4 percent.”

“St. Jude Medical sales of neuromodulation products were $101 million in the third quarter of 2012, down 1 percent from the comparable quarter of 2011. Revenue for the third quarter increased 2 percent after adjusting for the impact of foreign currency”

 

 
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Transient Electronics Opens Path Toward Absorbable, Transient AIMDs

Transient Electronics Dissolves in Water www.implantable-device.com David Prutchi PhD

Transient Electronics Dissolves in Water

A collaboration of Tufts Univeristy, University of Illinois and the Defense Advanced Research Projects Agency (DARPA) resulted in the development of electronic devices that dissolve in water or biological fluids dissolves and break down in traces of silicon and magnesium. Because of the small amount, these components can be harmlessly assimilated by biosystems like the human body, potentially opening the path to the development of implantable electronic devices that require only temporary implant, but instead of being surgically explanted, are simply allowed to get absorbed by the body after their mission is over.

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Boston Scientific Receives CE Mark for RELIANCE® 4-FRONT™ Defibrillation Lead

Boston Scientific ENDOTAK RELIANCE® 4-SITE™ Defibrillation Lead www.implantable-device.com David Prutchi, Ph.D.

Image Credit: Boston Scientific

Boston Scientific has received regulatory approval to market the RELIANCE® 4-FRONT™ lead, its next generation implantable defibrillation lead now available in Europe and Asia.   According to the press release, “The RELIANCE 4-FRONT lead is built upon the demonstrated performance and reliability of the RELIANCE lead platform with design enhancements intended to simplify the implant procedure. With more than 350,000 implants worldwide, RELIANCE leads have demonstrated a 98.9 percent survival probability at 8 years.

“Leveraging the RELIANCE platform, we made a series of targeted design enhancements with RELIANCE 4-FRONT to improve and simplify implantation,” said Kenneth Stein, M.D., chief medical officer of Boston Scientific’s Cardiac Rhythm Management Group. “RELIANCE 4-FRONT represents our continued dedication to product innovation to meet the needs of patients and physicians.”

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Boston Scientific Receives CE Mark of Vercise™ Deep Brain Stimulation System

Boston Scientific Vercise DBS System  www.implantable-device.com  David Prutchi, Ph.D.

Image Credit: Boston Scientific

Boston Scientific Corporation received CE Mark approval for use of its Vercise™ Deep Brain Stimulation (DBS) System for the treatment of Parkinson’s disease. The Vercise DBS System is the first and only commercially available DBS system to incorporate multiple independent current control, which is designed to selectively stimulate targeted areas in the brain. This system is an innovative technology that is designed to provide physicians fine control of stimulation.

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First Human Use of 24-Electrode Retinal Implant by Bionic Vision Australia

Bionic Vision Australia researchers announced on August 30, 2012 that they successfully performed the first implantation of an early prototype bionic eye with 24 electrodes.

According to the press release:

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Cognitive Prosthesis Enhances Short-Term Memory and Decision-Making in Primates

Cognitive Prosthesis www.implantable-device.com David Prutchi Ph.D.

Image Source: IOP Science

Scientists at Wake Forest University School of Medicine in Winston-Salem, North Carolina reported using a neural implant to stimulate higher-level thinking in monkeys, providing the first demonstration in primates of the sort of brain prosthesis that could eventually help people with damage from dementia, strokes or other brain injuries.  The study was published on Sept. 14 in IOP Publishing’s Journal of Neural Engineering.

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One for History Buffs: Pacemaker Made in Brasil

Implantable Pacemaker Made in Brasil. www.implantable-device.com  David Prutchi Ph.D.

My friend Daniel Villamil from CCC Medical in Uruguay sent me these pictures of a very unique device in his colection.  It is a late-1960s/early 1970s pacemaker made in Sao Paulo, Brasil.

UPDATE Oct 3, 2012:

CCC’s CEO Julio Arzuaga recalled that this pacemaker was manufactured in the early 1960s by the Instituto de Cardiologia Dante Pazzanese in Sao Paulo, Brasil.  The physicians leading the pacemaker team were Dr. Decio Kormann and Dr. Adib Jatene.

Dr. Orestes Fiandra used to implant these Brasilian pacemakers in Uruguay.  However, they were not very reliable.  For this reason, and with help from Drs. Kormann and Jatene, Dr. Fiandra started CCC del Uruguay as a more industrial environment for the production of pacemakers.

Implantable Pacemaker Made in Brasil. www.implantable-device.com  David Prutchi Ph.D.

 
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St. Jude Medical Receives CE Mark Approval of Eon Mini to Treat Chronic Migraine

St Jude Medical Eon and Eon Mini Spinal Cord StimulatorsSt. Jude Medical announced it has received European CE Mark approval of its Eon™ family of neurostimulators for treating patients with intractable chronic migraine.

According to the press release:

“Intractable chronic migraine is one of the most difficult-to-treat headache disorders,” said Professor Gennaro Bussone, M.D., head of the Neurological Department at Istituto Besta in Milan Italy. “By definition, people living with this condition are spending half their month living with debilitating headaches. This therapy expands our options in helping manage patients who suffer with disabling chronic migraine symptoms.”

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Boston Scientific Receives FDA Approval of S-ICD® for Patients at Risk of SCA

 

Cameron Health S-ICD subcutaneous defibrillator

Image Credit: Boston Scientific

On Sept. 28, 2012 Boston Scientific announced that the FDA granted regulatory approval for its S-ICD® System, the world’s first and only commercially available subcutaneous implantable defibrillator (S-ICD) for the treatment of patients at risk for sudden cardiac arrest (SCA). The S-ICD System sits entirely just below the skin without the need for leads to be placed into the heart.

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