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

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Home Articles posted by David Prutchi
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SetPoint Medical’s Vagus Nerve Stimulation for Treatment of Systemic Inflammation

SetPoint Medical, headquartered in Valencia, California, is developing neuromodulation therapies for patients with inflammatory autoimmune diseases, such as rheumatoid arthritis (RA), inflammatory bowel disease (IBD), psoriasis, diabetes, heart disease, and multiple sclerosis.  SetPoint’s proprietary neuromodulation platform consists of an implantable “microregulator”, wireless charger and iPad prescription pad application.

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

Toronto-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

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

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 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

 
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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

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

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 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

 
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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

 
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Transient Electronics Opens Path Toward Absorbable, Transient AIMDs

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

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

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.

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

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

 
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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

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.

 
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One for History Buffs: Pacemaker Made in Brasil

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

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

St. 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

 
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