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

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Home Archive for category "Therapies" (Page 6)
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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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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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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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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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Boston Scientific Receives FDA Approval of S-ICD® for Patients at Risk of SCA

  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

 
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Human Implants of Vestibular Prostheses at the Maastricht University Medical Center

Physicians at the Maastricht University Medical Center implanted two patients with vestibular prostheses.  These implants are similar to a cochlear implant, but instead of sound, conveys orientation and acceleration information to the vestibular organ that assists in preserving balance. According to lead implanter Prof. Robert Stokroos, preliminary assessment is promising, and research will be conducted to determine if the brain can

 
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TEDxCambridge Talk Calls for Open Data from AIMDs

In this TED talk, Hugo Campos explains his frustration with the fact that his ICD collects data, but he – as a patient – is unable to access these data as a diagnostic tool to help make good choices about eating, exercise and other activities.

 
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Nevro Receives FDA Approval to Initiate Trial of its High-Frequency Spinal Cord Stimulation Therapy

Nevro Corp announced that FDA has granted approval for initiation of its SENZA-RCT study, a U.S. prospective, randomized, controlled pivotal clinical trial evaluating the safety and efficacy of Nevro’s high-frequency spinal cord stimulation system for the treatment of chronic pain.

 
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FDA Approves St. Jude’s Assura™ ICDs That Reduce Inappropriate Shocks

St. Jude Medical today announced FDA approval of its Assura™ portfolio of implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds).The new implantable defibrillators feature SecureSense™ RV Lead Noise Discrimination, an algorithm that expands the St. Jude Medical ShockGuard® Technology and offers advanced sensing options designed to reduce the incidence of inappropriate shocks for patients

 
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EnteroMedics Reports $123k Revenue from Sales of its Maestro RC IPG for Treatment of Obesity

Today EnteroMedics recorded revenue for the first time since it was incorporated nearly eight years ago. The company reported revenue of about $123,000 in the first quarter of the year from the sale of its Maestro RC implantable vagus nerve stimulation system for treating obesity. Revenue was generated through sales by its distribution partner in Australia.

 
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