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

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Home Archive for category "AIMD Companies" (Page 6)
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Biotronik’s Iforia DF4 ICD/CRT-D CE-Approved as Compatible with MRI

Biotronik announced that it had received CE-approval for the world’s first DF4 ICD/CRT-D series approved for MRI. In addition, this series contains one of the world’s smallest ICDs– the Iforia single chamber ICD. Aside from featuring ProMRI®technology, which allows patients to undergo potentially life saving MRI scans, Iforia also includes the industry standard DF4 connector

 
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CircuLite Receives Approval to Start IDE Trial of its SYNERGY Circulatory Support System

The SYNERGY Circulatory Support System is a micro-blood pump that provides up to 4.25 liters of blood per minute and reduces the heart’s workload, while improving blood flow to vital organs. The system is surgically implanted using a mini-thoracotomy and the micro-pump is placed in a pacemaker-like pocket. The system’s less invasive procedure is intended

 
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Retina Implant AG Publishes Study Results on its Alpha IMS Implant

Retina Implant AG published study results on its Alpha IMS Implant for functional vision restoration.  According to the press release, “Retina Implant AG, the leading developer of subretinal implants for patients blinded by retinitis pigmentosa (RP), announced results from part of its multicentre study were published today in the peer-reviewed journal Proceedings of the Royal

 
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Second Sight Receives FDA Clearance for Argus II Retinal Prosthesis

On February 4, 2013, after more than 20 years of research and development, Second Sight Medical Products, Inc., announced that its Argus® II Retinal Prosthesis System (“Argus II”) has received U.S. market approval from the Food and Drug Administration (FDA) to treat individuals with late stage retinitis pigmentosa (RP). This announcement follows receipt of the European

 
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Boston Scientific Releases 2012 AIMD Sales Report: CRM Down 7%, Neuromodulation Up 9%

Boston Scientific reported Q4 2012 CRM sales of $457M versus $482M for Q4 2011, or a decline of 5% (4% on constant-currency basis).  For the same period, neuromodulation sales grew by 14% from $91M to $104M. Worldwide CRM sales for the full 2012 year were $1,908M compared to $2,087M for 2011, or a decline of 9%

 
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Medtronic Introduces First Neuromodulation Systems Compatible with Full-Body MRI

Medtronic has introduced in Europe the first and only implantable neurostimulation systems indicated for use in the treatment of chronic back and/or leg pain that are designed for full-body Magnetic Resonance Imaging (MRI) scans under specific conditions.  Medtronic SureScan neurostimulation systems include enhancements to existing devices as well as specially designed leads to reduce or

 
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St. Jude Releases 2012 Year-End Results: CRM Down 6%, Neuromodulation Up 1%

St. Jude Medical today reported sales and net earnings for the fourth quarter and year ended December 29, 2012.   According to the announcement: “Total CRM sales, which include implantable cardioverter defibrillator (ICD) and pacemaker products, were $682 million for the fourth quarter of 2012, a 6 percent decrease compared to the fourth quarter of 2011.

 
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SetPoint Medical’s Vagus Nerve Stimulation for Treatment of Systemic Inflammation

SetPoint Medical, headquartered in Valencia, California, is developing neuromodulation therapies for patients with inflammatory autoimmune diseases, such as rheumatoid arthritis (RA), inflammatory bowel disease (IBD), psoriasis, diabetes, heart disease, and multiple sclerosis.  SetPoint’s proprietary neuromodulation platform consists of an implantable “microregulator”, wireless charger and iPad prescription pad application.

 
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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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Boston Scientific’s Q3 2012 AIMD Results: CRM Dropped 6%, Neuromodulation Up 5%

Today Boston Scientific reported its results for Q3 2012.  For its AIMD divisions: Cardiac Rhythm Management sales dropped from $503M in Q3 of 2011 to $462M for this year (-8%), a 6% decrease on constant-currency basis. Neuromodulation sales grew by 5% from $84M to $88M.

 
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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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St. Jude’s Q3 2012 AIMD Results: CRM Maintains Downward Trend, Neuromodulation Steady

St. Jude announced today its third quarter 2012 results.  From the press release: “Total CRM sales, which include implantable cardioverter defibrillator (ICD) and pacemaker products, were $691 million for the third quarter of 2012, an 8 percent decrease compared with the third quarter of 2011. Total CRM sales for the third quarter decreased 4 percent

 
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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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