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"
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Destron Fearing Bio-Thermo Pet ID + Temperature Sensor Implantable Tag

“Bio-Thermo” implantable tags combining animal ID and temperature measurement are manufactured by Destron Fearing (www.destronfearing.com).  The Bio-Thermo tags were originally produced by a company named “Digital Angel” in Delray Beach, FL. The Bio-Thermo tag is covered under a 2006 US Patent No. 7,015,826 “Method and Apparatus for Sensing and Transmitting a Body Characteristic of a

 
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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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Pacesetter’s 1973 Rechargeable Pacemaker

Yesterday I visited the Udvar-Hazy Center of the Smithsonian Air & Space Museum in Chantilly, VA.  There I found this demo rechargeable pacemaker being displayed as a spinoff of NASA’s technology with the following explanation: I can’t remember exactly where I found the picture of a Pacesetter model BD102 VVI, but the story behind it

 
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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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St. Jude Implants First US Patient with its Nanostim Leadless Cardiac Pacemaker

St. Jude today announced the first U.S. implant in the company’s LEADLESS II pivotal trial designed to evaluate the Nanostim™ leadless pacemaker for FDA approval. The world’s first retrievable, non-surgical pacemaker was implanted at The Mount Sinai Hospital in New York City by Dr. Vivek Reddy.  The LEADLESS II pivotal trial is a prospective, non-randomized,

 
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Reveal LINQ: Medtronic’s New Miniaturized Insertable Cardiac Monitoring System

Medtronic’s new Reveal LINQ Insertable Cardiac Monitor is a tiny implantable device that weighs less than three grams and is far less invasive than any previous loop recorder.  The figure above shows its diminutive size compared to the Reveal XT device – it is a full 87% smaller!  The Reveal LINQ is a leadless device that

 
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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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