St. Jude expands EnSite Precision launch in EU, seeks FDA approval

St. Jude Medical (NYSE:STJ) said today it is expanding its commercial release of its EnSite Precision cardiac mapping system in the European Union, and that it is currently pursuing FDA clearance of the system. The St. Paul, Minn.-based company’s Ensite cardiac mapping system is designed for use in ablation procedures to visualize and aid in catheter navigation in the heart, providing detailed anatomical models and maps. The system is designed to aid in diagnosing arrhythmias, guiding therapy and providing expanded procedural options. “We developed the EnSite Precision system with insight from world-renowned electrophysiologists to encompass leading mapping capabilities. Providing a best-in-class mapping system combining speed and detail with precision and stability allows physicians to have the information they need to treat both straightforward and complex arrhythmias,” clinical, medical and scientific affairs veep Dr. Srijoy Mahapatra said in a prepared release. The expanded release includes a new suite of technologis including improved hardware and software features, the company said. “The EnSite Precision system is precise, reliable, accurate and it’s fast. This is very important when it comes to the demands of today’s electrophysiologists, especially as we see more patients with complex substrate based arrhythmias. This is really what we need to push clinical electrophysiology forward to a better level of successful case executio...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Blog St. Jude Medical Source Type: news

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AbstractPurpose of reviewIn this review article, we aim to describe the pathophysiology of concomitant atrial fibrillation and both left and right heart failure, as well as pronounce the prognosis of having these two conditions simultaneously. This review also summarizes the current management of atrial fibrillation including stroke and thromboembolism prevention in the presence of systolic and diastolic heart failure.Recent findingsWhile rhythm control strategy is not superior to rate control strategy in atrial fibrillation patients without heart failure, catheter ablation for atrial fibrillation has shown to improve outc...
Source: Current Treatment Options in Cardiovascular Medicine - Category: Cardiology Source Type: research
Int J Angiol DOI: 10.1055/s-0040-1708529Atrial fibrillation is the most common arrhythmia in the adult population, and its incidence and prevalence are still rising. Cardiac devices are widely used in clinical practice in the management of various rhythm disturbances and heart failure treatment. Many patients who receive a pacemaker, implantable cardioverter-defibrillator, or cardiac resynchronization therapy also experience atrial fibrillation in the course of their life. Therefore, this review aims to describe the role of these devices in the treatment and prevention of atrial fibrillation in the device recipients. In ad...
Source: International Journal of Angiology - Category: Cardiology Authors: Tags: Review Article Source Type: research
AbstractAtrial fibrillation and other atrial tachyarrhythmias are increasing with age and concomitant morbidity. First options in symptomatic patients are drug treatment and catheter ablation. Nevertheless, a considerable number of patients suffer from refractory atrial tachyarrhythmias despite treatment. Atrioventricular node ablation (AVNA) may be helpful in many of these patients. Therefore, we investigated AVNA patients with a long-term follow-up. We enrolled 82 patients with a follow-up longer than 1  year receiving AVNA for drug- and ablation-resistant atrial tachyarrhythmias (AA) in a retrospective manner. Mean...
Source: Heart and Vessels - Category: Cardiology Source Type: research
Abstract Objectives: To examine the association between the echocardiographic parameters measured as left atrial diameter (LAD) and left ventricular end-diastolic diameter (LVEDD) and long-term risk of all-cause mortality in adults with hypertrophic cardiomyopathy (HCM) following pacemaker implantation. Methods: A total of 94 adult patients with HCM who underwent pacemaker implantation from November 2002 to June 2013 in our Arrhythmia Center for symptomatic bradycardia and did not receive an implantable cardiac defibrillator (ICD) or cardiac resynchronization therapy (CRT) during follow-up were retrospectivel...
Source: Cardiology Research and Practice - Category: Cardiology Authors: Tags: Cardiol Res Pract Source Type: research
ConclusionFemales were associated with persistently reduced odds of receipt of CRT-D compared to males over an eleven-year period. The present study identifies important factors that predict the choice of CRT device offered to patients in the US.
Source: Canadian Journal of Cardiology - Category: Cardiology Source Type: research
Michel Mirowski and his colleagues gave the field of implantable cardioverter-defibrillators (ICDs) a pretty good start, but what's more impressive is how far the technology has advanced since that first human ICD implant in February 1980. In the past 40 years we've seen ICDs become dramatically smaller, longer lasting, more capable, more personalized, subcutaneous (non-transvenous), and even MRI-firendly. And that's not to mention the advanced data connectivity and monitoring capabilities that the latest technologies offer. So without further ado, let's take a look at the current ICD landscape and the companie...
Source: MDDI - Category: Medical Devices Authors: Tags: Implants Source Type: news
Purpose of review It has been nearly 2 decades since His bundle pacing (HBP) was described and with very first randomized pilot study published, reviewing its impact on clinical practice is inevitable. Recent findings Inclusion of HBP in the guidelines, along with long-term outcomes, outcomes comparing selective and non selective HBP and investigator initiated randomized pilot comparing with cardiac resynchronization therapy, HBP has established itself as a feasible pacing alternative. Summary HBP is an addition to the current armada of resynchronization techniques. HBP is an emerging area of interest, and is parti...
Source: Current Opinion in Cardiology - Category: Cardiology Tags: ARRHYTHMIAS: Edited by Wilber W. Su Source Type: research
AbstractHeart failure with reduced ejection fraction (HFrEF) is common in patients with adult congenital heart disease. Many of the most common congenital defects have a high prevalence of HFrEF, including left-sided obstructive lesions (aortic stenosis, coarctation of the aorta, Shone complex), tetralogy of Fallot, Ebstein anomaly, lesions in which there is a systemic right ventricle, and lesions palliated with a Fontan circulation. However, heart failure with preserved ejection fraction (HFpEF) is also prevalent in all these lesions. Comprehensive evaluation includes physical exam, biomarkers, echocardiography and advanc...
Source: Heart Failure Reviews - Category: Cardiology Source Type: research
Background: Tpeak-Tend interval (TpTe), a measurement of transmural dispersion of repolarization (TDR), has been shown to predict ventricular tachyarrhythmia in cardiac resynchronization therapy with defibrillator (CRT-D) patients. However, the ability of TpTe to predict ventricular tachyarrhythmia and mortality for heart failure patients with a cardioverter-defibrillator (ICD) is not clear. The purpose of this study was to assess the predictive ability of TpTe in heart failure patients with ICD. Methods and results: We enrolled 318 heart failure patients treated after ICD. Patients were divided into 3 groups accordin...
Source: Medicine - Category: Internal Medicine Tags: Research Article: Observational Study Source Type: research
The residual risk of ventricular arrhythmia (VA) after cardiac resynchronization therapy (CRT) implantation in patients with non-ischemic cardiomyopathy (NICM) remains difficult to evaluate. The impact of left ventricular (LV) wall thickness (WT) measured using computed tomography (CT) on the occurrence of VA after CRT implantation has never been investigated. In this pilot study, we examined the association of LVWT and the occurrence of VA in NICM patients receiving CRT. Thirty three patients with NICM scheduled for CRT underwent pre-procedural CT.
Source: The American Journal of Cardiology - Category: Cardiology Authors: Source Type: research
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