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

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Home Treated Conditions Archive for category "Tachycardia"
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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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St Jude Receives CE Mark for Quadra Assura MP™ Multipoint CRT-D

St. Jude Medical today announced CE Mark approval of its next-generation quadripolar device, the Quadra Assura MP™ cardiac resynchronization therapy defibrillator (CRT-D). The device features MultiPoint™ Pacing (MPP) technology that enables physicians to pace multiple locations on the left side of the heart. This gives the clinician more choices to best optimize cardiac resynchronization therapy (CRT)

 
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FDA Approves St. Jude’s Ellipse™ and SJM Assura™ Portfolio of ICDs and CRT-D Devices

St. Jude Medical announced FDA approval of its next-generation Ellipse™ and SJM Assura™ portfolio of implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). The new devices are designed to lower the risk of lead abrasion and to ensure high-voltage therapy delivery. According to the announcement: The Ellipse and SJM Assura family of devices

 
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Sorin Receives FDA Approval for SMARTVIEW™ Remote Monitoring Solution

Sorin today announced it received FDA approval for and is beginning the U.S. launch of the SMARTVIEW™ remote monitoring solution for patients with CRM devices.  From the press release: “Using the secure SMARTVIEW remote monitoring solution, physicians and nurses following patients with a Sorin PARADYMTM RF device can access valuable cardiac data and alert messages from

 
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Biotronik Receives FDA Approval for Ilesto 7 ICD/CRT-D Series

Biotronik announced that FDA granted approval for its Ilesto 7 implantable cardioverter-defibrillator/cardiac resynchronization therapy defibrillator (ICD/CRT-D) series. According to the press release: “BIOTRONIK lives up to its reputation for excellence in design and manufacturing with the introduction of the Ilesto family, and the new Ilesto DX device. Physicians depend on complete and timely information, and Ilesto

 
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Medtronic Announces FDA Approval of Next-Generation CRT-D and ICD IPG Families

Medtronic announced today the FDA approval of its new Viva® portfolio of cardiac resynchronization therapy with defibrillation (CRT-D) devices, and the Evera® portfolio of implantable cardioverter-defibrillators (ICD).  According to the press release: “The Viva CRT-D significantly improves response rate to the therapy for many indicated heart failure patients, with a demonstrated 21 percent reduction in overall

 
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Sorin Receives Conditional FDA IDE Approval to Study its Paradym CRT-D IPG and SonRtip Hemodynamic Sensor Lead

Sorin announced it received U.S. Food and Drug Administration (FDA) conditional approval for its Investigational Device Exemption (IDE) application and clinical trial protocol for RESPOND CRT. The trial will study the safety and effectiveness of the innovative SonR cardiac resynchronization therapy (CRT) optimization system in patients with advanced heart failure. RESPOND CRT is a multi-center,

 
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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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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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RF Programming Hack Demonstrates Potentially Fatal ICD Exploit

I received today a link to a very interesting article which plays on the fears of the public, and which I am sure will result in tough new regulations to our industry. The article discusses how IOActive researcher Barnaby Jack reverse-engineered a “pacemaker transmitter” (probably a programmer or a MICS module) to command ICDs within a 30

 
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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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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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Boston Scientific Receives FDA Approval of S-ICD® for Patients at Risk of SCA

  On Sept. 28, 2012 Boston Scientific announced that the FDA granted regulatory approval for its S-ICD® System, the world’s first and only commercially available subcutaneous implantable defibrillator (S-ICD) for the treatment of patients at risk for sudden cardiac arrest (SCA). The S-ICD System sits entirely just below the skin without the need for leads to be

 
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FDA Approves St. Jude’s Assura™ ICDs That Reduce Inappropriate Shocks

St. Jude Medical today announced FDA approval of its Assura™ portfolio of implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds).The new implantable defibrillators feature SecureSense™ RV Lead Noise Discrimination, an algorithm that expands the St. Jude Medical ShockGuard® Technology and offers advanced sensing options designed to reduce the incidence of inappropriate shocks for patients

 
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iPacemaker Implantable Pacemaker/ICD Database for the iPhone

My friend and colleague Dr. Irit Yaniv alerted me to this iPhone app that was just released.  It is an implantable pacemaker and defibrillator database that, according to its author, displays up to 70 parameters for each model, includes battery and longevity data, and links directly to product manuals.

 
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