News

Biosense Webster Announces FDA Approval of the ThermoCool® SF Catheter in the United States

Biosense Webster, Inc. announced the FDA approval of the new ThermoCool® SF irrigated ablation catheter in the United States.

The ThermoCool® SF NAV Catheter combines Biosense Webster’s latest irrigated ablation technology with the accurate visualization of the Carto®3 3D Mapping & Ablation System. The catheter was launched in Europe in October 2010, and has received excellent feedback from electrophysiologists who have used the product.



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FDA Approves Xarelto to Prevent Stroke in People With Common Type of Abnormal Heart Rhythm

The U.S. Food and Drug Administration approved the anti-clotting drug Xarelto (rivaroxaban) to reduce the risk of stroke in people who have abnormal heart rhythm (non-valvular atrial fibrillation).
Atrial fibrillation occurs in more than 2 million Americans and is one of the most common types of abnormal heart rhythm. In atrial fibrillation, the beating of the heart’s two upper heart chambers is irregular and poorly coordinated.



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Medtronic Announces Results from TTOP-AF Trial Demonstrating Clinical Benefits of Its Phased RF Ablation System in Treating Persistent Atrial Fibrillation

Medtronic, Inc. announced results from its Tailored Treatment of Permanent Atrial Fibrillation (TTOP-AF) clinical trial, the first randomized study comparing ablation therapy with the Medtronic Phased RF Ablation System ablation system to traditional medical management (antiarrhythmic drugs and direct current cardioversion) in 210 patients with persistent or longstanding persistent atrial fibrillation (AF).



News

FDA Clears New Rapid, Large-Area, and Radiopaque Temperature Sensing Probe and System

CIRCA Scientific announced that its CIRCA S-CATH and CIRCA Temperature Monitoring System have received 510(k) clearance in the U.S. by the Food and Drug Administration (FDA).

The CIRCA S-CATH and the CIRCA Temperature Monitoring System address the problems associated with slow, single sensor, and small surface area standard esophageal temperature probes and monitors.



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HeartLight Endoscopic Ablation System Now Available in the UK

CardioFocus, Inc., developer of the HeartLight Endoscopic Ablation System (EAS) for the treatment of atrial fibrillation (AF), announces that the HeartLight EAS is now available in the United Kingdom. The first AF patients were treated at The Heart Hospital in London on Wednesday, August 17, with additional cases to take place throughout the month.



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Biosense Webster Enrolls First Patient in Groundbreaking SMART-AF Trial

Biosense Webster, Inc. announced the enrollment of the first patient in their latest groundbreaking clinical trial, the SMART-AF Investigational Device Exemption (IDE) study, and the treatment of the first patient with the new ThermoCool® SmartTouch™ Contact Force Sensing Catheter and Software Module in the United States.



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Cardiovascular Credentialing International to Sunset On-the-Job Training as Qualification Pathway for Invasive Registry Examination  

Effective July 1, 2013, Cardiovascular Credentialing International (CCI) will officially remove the RCIS1 Qualification (also referred to as the On-the-Job Training qualification) that allows applicants who only have two years (full-time or full-time equivalent) working in Invasive Cardiovascular Technology, at the time of application, to qualify for CCI's Invasive Registry examination. The Invasive Registry examination is the required examination for the Registered Cardiovascular Invasive Specialist (RCIS) credential.



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Sorin Group Receives CE Mark Approval for PARADYM™ RF ICDs and CRT-Ds

Sorin Group announced the CE mark approval for the PARADYM™ RF1 family of implantable cardiac defibrillators and cardiac resynchronization therapy devices.

Sorin Group, a global medical device company and a leader in the treatment of cardiovascular diseases, announced the CE mark approval for the PARADYM™ RF1 family of implantable cardiac defibrillators (ICDs) and cardiac resynchronization therapy devices (CRT-D). With their proprietary algorithms, SafeR™ and Parad+™, PARADYM™ RF remote monitoring-enabled ICDs and CRT-D automatically adjust to provide individualized, appropriate therapy in a thin, powerful, long-lasting device.



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New Study of Medicare Beneficiaries Reveals Significant Cost Burden, High Mortality Associated with Patient Infections Following Cardiac Device Implantation

Surgical infections associated with pacemakers and defibrillators led to 3-fold increases in hospital stay, 55–118% higher hospitalization costs, 8- to 11-fold increase in mortality rates, and double the mortality after 1 year compared to pacemaker and defibrillator implantations where no infection occurred. Surprisingly, more than one-third of the excess mortality occurred after hospital discharge. These findings, from a new study in Medicare beneficiaries of more than 200,000 pacemaker and defibrillator implantations with and without infection, were presented at a poster session at the American College of Cardiology 60th Annual Scientific Session by researchers from the Mayo Clinic, the Johns Hopkins School of Medicine, and TYRX, Inc.



News

Advanced Cardiac Therapeutics Initiates First-In-Man CE Mark Clinical Trial to Study Innovative Catheter System for the Treatment of Atrial Arrhythmias

Advanced Cardiac Therapeutics, Inc., a developer of innovative temperature-sensing cardiac ablation systems, announced that the first patients have been enrolled in a first-in-man CE Mark clinical trial of the safety and performance of the company’s TEMPASURE™ cardiac ablation catheter. The TEMPASURE system is the world’s first RF cardiac ablation catheter to offer both saline irrigation and temperature-sensing technology.