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

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Medtronic Performs First Human Implant of its Micra Leadless Pacemaker

  According to the press release: At one-tenth the size of a conventional pacemaker, and comparable in size to a large vitamin, the Micra TPS is delivered directly into the heart through a catheter inserted in the femoral vein. Once positioned, the pacemaker is securely attached to the heart wall and can be repositioned if

 
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Sorin Announces CE Mark and Implant of its MRI-Compatible Kora 100 Pacemaker with Automatic MRI Mode

Sorin announced the CE Mark approval and first implant of its KORA 100 pacing system. According to the press release: KORA 100 SR and DR pacemakers when implanted with the Sorin BEFLEX pacing lead enable implanted patients to undergo magnetic resonance imaging (MRI) safely.[1] Pacemaker patients are typically older than 65 years. This patient population

 
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EnteroMedics Reports Maestro Obesity Study Showing 25% Reduction in Excess Weight

EnteroMedics reported new clinical trial data for its Maestro system, which is designed to treat obesity through vagus nerve stimulation. The company said that its Maestro RC system lost 25% of their excess weight, or 10% of their total body weight, after 18 months. Patients who received a sham implant lost 12% of excess weight,

 
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Boston Scientific Reports Good Results with Precision Spectra™ SCS

Retrospective data for Boston Scientific’s Precision Spectra™ Spinal Cord Stimulator (SCS) System were presented at the North American Neuromodulation Society (NANS) 17th annual meeting in Las Vegas. The data show that the device provided highly significant pain relief three months after implantation. According to the press release: Precision Spectra is the first SCS System designed

 
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Medtronic Implants Activa® PC+S DBS IPG in US

Medtronic today announced the first US implant of the novel Activa® PC+S deep brain stimulation (DBS) system that, for the first time, enables the sensing and recording of select brain activity while simultaneously providing targeted DBS therapy. According to the press release: MINNEAPOLIS – December 5, 2013 – Medtronic, Inc. (NYSE: MDT) today announced the

 
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St. Jude Studies Combined PNFS and SCS for Chronic Low Back and Leg Pain

St. Jude announced today that it has launched the SENSE™ Subcutaneous and Epidural Neuromodulation System Evaluation study – a clinical study to evaluate the combination of peripheral nerve field stimulation (PNfS), and spinal cord stimulation (SCS), to determine whether the two therapies together offer more effective management of chronic low back and leg pain than SCS

 
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St. Jude Launches SUNBURST Study to Evaluate New Prodigy Neurostimulator’s Burst Stimulation for Chronic Pain

St. Jude announced today that it has initiated a clinical study of the Prodigy™ neurostimulator, which is the first SCS system able to deliver a proprietary mode of stimulation therapy called burst stimulation. The purpose of the SUNBURST™ (Success Using Neuromodulation with BURST) study is to evaluate whether burst stimulation can be more effective in

 
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Cerbomed’s Non-Invasive Vagus Nerve Stimulator Poses Challenge to Implantable VNS Systems

Cerbomed GmbH, located in Erlangen, Germany, was founded in 2005 to develop transcutaneous Vagus Nerve Stimulation (t-VNS®) neuromodulation systems. Surgically accessing the Vagus Nerve is not trivial, and implanting a VNS system involving cuff electrodes is risky and recovery is lengthy.  Enter t-VNS, which is delivered non-invasively to the auricular branch of the vagus nerve (ABVN), making

 
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Abrupt Increase in Thoratec HeartMate II LVAD Thrombosis Reported in NEJM

A study published on Nov 27, 2013 in the New England Journal of Medicine reports on a sudden increase in the incidence of pump thrombosis with the Thoratec HeartMate II LVAD. The study shows an unexplained increase in thrombosis when comparing LVAD patients at three centers from January 2004 to March 2011 vs. those implanted March

 
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EndoStim’s LES System Approved in Argentina for GERD Treatment

EndoStim announced that Argentina’s National Administration of Drugs, Food and Medical Technology (ANMAT) approved its Lower Esophageal Sphincter (LES) Stimulation System for Gastroesophageal Reflux Disease (GERD). EndoStim is currently available in Europe, Asia and several other countries in Latin America such as Chile and Colombia.  

 
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Microbattery Fabricated by 3D Printing May Power Implantable Devices

Researchers at Harvard University and the University of Illinois at Urbana-Champaign have created and tested 3D printing inks that are electrochemically active, and with which microbatteries can be fabricated. The ink for the anode incorporates nanoparticles of one lithium metal oxide compound, while the ink for the cathode has another type of nanoparticles. A 3D

 
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Cyberonics Reports Record Sales for its Fiscal Q2 2014

Cyberonics reported $70.1 million in sales for the quarter (fiscal Q2 2014), up around 12% from than $62.9 million booked in the fiscal 2013 second quarter. Net income grew, but at a more moderate pace. It surpassed $13.8 million, versus $13.5 million in net income booked during the same period a year ago.  Operating result highlights for

 
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European Heart Rhythm Association Issues Very Interesting Report on New Devices for the Treatment of Heart Failure

  A position paper was published yesterday by the European Heart Rhythm Association reporting on the performance of new devices for the treatment of heart failure (HF). The report has been endorsed by the Heart Failure Association. The abstract for the paper titled “New devices in heart failure: an European Heart Rhythm Association report” reads:

 
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NanoWattICs Establishes Working Relationship with Rosellini Scientific to Develop Suite of Neurostimulation Devices

ASIC designer NanoWattICs (Uruguay) and Rosellini Scientific (Dallas, TX) have announced they have entered into a collaborative relationship for the development of a suite of neurostimulation devices comprising implantable, wireless and non-invasive technologies.  From the press release: Rosellini Scientific, LLC (“Rosellini Scientific”; Dallas, TX, USA) and NanoWattICs SRL (“NanoWattICs”; Montevideo, UY) are pleased to formally announce

 
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Medtronic Advisa and Revo MRI SureScan Pacemakers Delays Atrial Fibrillation Disease Progression

Results for the MINERVA Trial were presented at the AHA Meeting, showing that  Medtronic Advisa and Revo MRI(TM) SureScan(TM) pacemakers reduce the progression of permanent AF by 61%.  According to the press release: Presented as a late breaking clinical trial at the American Heart Association’s Scientific Sessions 2013, the MINERVA (MINimizE Right Ventricular pacing to prevent Atrial

 
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