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 "Heart Failure (CHF)"
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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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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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FDA Panel Majority Votes Against Effectiveness of CardioMEMS CHAMPION HF Monitoring Device

Although the FDA advisory panel found CardioMEMS’ CHAMPION HF Pressure Measurement System to be safe, on October 9, 2013, the majority of panel members decided that the implantable sensor monitor to help guide treatment in patients with congestive heart failure is not effective. According to Forbes, one panel member said it was difficult to connect the dots between

 
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Enopace Receives Additional $5M Investment for Development of Stimulator for Treatment of Heart Failure

Sorin recently announced a $5 million investment in Israeli startup Enopace Biomedical, which is developing an endovascular neurostimulation system for heart failure.  Back in October 2011 Sorin invested $7 million to finance the initial clinical studies of Enopace’s technology as well as ongoing product development. Very scant details are available besides that it is developing

 
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Neuromodulation Startup NeuroTronik Raises $13.1M for Development of System for Treating Acute Heart Failure Syndrome

NeuroTronik, a recent spin-off from Synecor, a Chapel Hill business accelerator, announced that it has raised $13.1M for the development of a neuromodulation system intended for the treatment of acute heart failure syndrome. Douglas Reed, a partner in the VC group backing NeuroTronik said that the device aims to shorten hospital stays and reduce the need of

 
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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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St. Jude Launches Allure Quadra™ CRT-P IPG with Quadripolar Lead Technology

St. Jude Medical today announced CE Mark approval and European launch of its Allure Quadra™ Cardiac Resynchronization Therapy Pacemaker (CRT-P), which brings the quadripolar lead technology to the pacemaker market for the first time.  According to the press release: “Quadripolar leads allow for increased implant efficiencies, which clinical data indicates can result in fewer surgical revisions.

 
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Impulse Dynamics Launches CE-Marked OPTIMIZER IVs System for the Treatment of Heart Failure

Impulse Dynamics (yes, the company for which I work) launched its new, CE-marked OPTIMIZER™ IVs implantable device for the treatment of heart failure at the 79th Annual Meeting of the German Cardiac Society (Mannheim, Germany, 3–6 April 2013). The OPTIMIZER™ IVs Implantable Pulse Generator (IPG) is a programmable telemetric device intended to treat moderate to severe heart

 
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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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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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