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

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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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Medtronic Reports CRM AIMD Sales Trend Showing Stabilization + Strong Earnings from Neuromodulation AIMDs

Medtronic released today its earning reports for the second quarter of fiscal year 2014, which ended October 25, 2013. Medtronic states in the press release: “Second quarter revenue from Implantable Cardioverter Defibrillators (ICDs) was $713 million, an increase of 4 percent on a constant currency basis in a market that continues to show a trend

 
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NeuroPace Receives FDA PMA Approval for for the RNS System to Treat Refractory Partial Epilepsy

NeuroPace is a privately-held company in Mountain View, CA. Their RNS® implantable stimulator, along with depth leads and cortical strip leads are designed for the treatment of medically refractory partial epilepsy. On November 14, 2013, NeuroPace has now received FDA pre-market approval for the NeuroPace RNS System as a treatment for adults with partial onset

 
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AAMI Technical Information Report Gives Guidance to AIMD Designers Regarding MRI Compatibility

A new technical information report (TIR) provides guidance to design active implantable medical device manufacturers for use in patients who may need magnetic resonance imaging (MRI) scans. ANSI/AAMI/ISO TIR10974:2012, “Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device” was adopted and published by AAMI is meant to inform

 
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WISE s.r.l. Raises €1M to Develop Flexible Electrodes for Spinal Cord Stimulation

WISE (Wiringless Implantable Stretchable Electronics), a Milan- and Berlin-based medical device companyraised a seed-round of € 1 M to advance the development of its first product aimed at the spinal cord stimulation market. WISE’s technology relies on Supersonic Cluster Beam Implantation (SCBI) for the metallization of polymers and elastomers. SCBI allows to fabricate complex microelectronic

 
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Interesting Article in Medical Design Briefs: Designing an ASIC Chip to Control an Implantable Glucose Measurement Device

The current issue of Medical Design Briefs carries an interesting article titled “Designing an ASIC Chip to Control an Implantable Glucose Measurement Device” by Uwe Guenther of ZMDI (Dresden, Germany) and Andrew DeHennis of Senseonics (formerly known as “Sensors for Medicine and Science, Inc.” in Germantown, MD). Zentrum Mikroelektronik Dresden AG (ZMDI), Dresden, Germany, partnered

 
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Nyxoah Developing Implant for Obstructive Sleep Apnea and Snoring

Nyxoah was founded in 2009 by Robert Taub and Dr. Adi Mashiach to develop neurostimulation treatments focused for Obstructive Sleep Apnea. Nyxoah is currently engaged in clinical tests of a tiny, battery-less implantable neurostimulator that can electrically control the nerves of the tongue and so prevent airway blockage. According to Nyxoah, the implantable device is

 
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