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

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Home Therapies Archive for category "Neural Stimulation"
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St. Jude’s Protégé Upgradeable Neurostimulator Receives FDA Approval

St. Jude Medical today announced the approval of its Protégé™ IPG from the U.S. Food and Drug Administration (FDA). Protégé is the first and only neurostimulation system that allows spinal cord stimulation (SCS) technology upgrades as they are approved to be made via software updates.  According to the press release: Chronic pain sufferers implanted with

 
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Greatbatch Submits Application for CE Mark for its SCS System

On January 20, 2014, Mass Device reported that Greatbatch filed a CE Mark application for its spinal cord stimulation system with German notified body TÜV SÜD America.  The spinal cord stimulation system comes from Greatbatch’s subsidiary, QiG Group. The company also applied for pre-market approval last month.  

 
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SecondSight Starts US Commercial Implants of Argus II Retinal Prosthesis

On Jan 29, 2014, Second Sight Medical announced that it had performed the first commercial implants of the Argus II visual prosthetic at the University of Michigan’s Kellogg Eye Center.  Second Sight plans to provide updates during a press conference at the American Society of Cataract and Refractive Surgery conference in April, after the patients complete

 
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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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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 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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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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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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