St. Jude wins CE Mark for expanded suite of cardiac leads

St. Jude Medical (NYSE:STJ) said today it won CE Mark approval in the European Union and launched 3 new Quartet left ventricular leads. The newly released leads are designed for more effective targeting of individual cardiac anatomies for patients who require cardiac resynchronization therapy pacers and defibs, the company said. “Heart and blood vessel anatomy vary from patient to patient so having multiple sizes and spacing options with the Quartet quadripolar lead helps me to treat all of my patients in need of cardiac resynchronization therapy. We are now able to place the quadripolar lead in the best possible location for that patient, capturing more cardiac tissue to give heart failure patients the best opportunity to respond,” Dr. Sami Pakarinen of Finland’s Helsinki University Central Hospital said in a press release. St. Paul, Minn.-based St. Jude Medical said the leads are designed to be used with next-gen MultiPoint Pacing technologies which allows for pacing in multiple locations on the left side of the heart. A select number of the newly cleared products area also compatible with magnetic resonance imaging, as well as the company’s Quadra Assura CRT-D and Quadra Assura MP CRT-D with MultiPoint Pacing, the company said. “These lead choices allow physicians to identify what lead spacing option will work best for each patient so they can individualize care. The expanded selection of quadripolar pacing leads reinforces St. Jude ...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Cardiac Assist Devices Cardiac Implants Cardiovascular Regulatory/Compliance St. Jude Medical Source Type: news

Related Links:

AbstractBackgroundThe importance of interlead electrical delays (IEDs) in the presence of scar tissue for response to cardiac resynchronization therapy (CRT) in patients with ischemic cardiomyopathy is poorly described.MethodsSixty ‐eight CRT patients with ischemic cardiomyopathy and left bundle branch block were included. IEDs, the time between sensing of native impulse at the RV lead and LV lead, were measured at implantation and after 8 months. Magnetic resonance imaging was used for assessment of scar tissue. Echocardiog raphic response was defined as ≥ 15% decrease in left ventricular end‐systolic vol...
Source: Pacing and Clinical Electrophysiology : PACE - Category: Cardiology Authors: Tags: DEVICES Source Type: research
n H Abstract Aims Heart failure patients with LV dyssynchrony often do not respond to cardiac resynchronization therapy (CRT), indicating that the pathophysiology is insufficiently understood. Intracardiac hemodynamic forces computed from 4D flow MRI have been proposed as a new measure of cardiac function. We therefore aimed to investigate how hemodynamic forces are altered in LV dyssynchrony. Methods 31 patients with heart failure and LV dyssynchrony and 39 controls underwent cardiac magnetic resonance imaging with acquisition of 4D flow. Hemodynamic forces were computed using the Navier-Stokes equations and inte...
Source: American Journal of Physiology. Heart and Circulatory Physiology - Category: Physiology Authors: Tags: Am J Physiol Heart Circ Physiol Source Type: research
Cardiac resynchronization therapy (CRT) improves symptoms of heart failure (HF), morbidity and mortality in selected population. The aim of the study was to investigate the impact of cardiac magnetic resonance (CMR)-guided left ventricular (LV) lead placement on clinical outcomes and LV reverse remodelling in CRT recipients.
Source: International Journal of Cardiology - Category: Cardiology Authors: Source Type: research
Patients with drug-refractory heart failure can greatly benefit from cardiac resynchronization therapy (CRT). A CRT device can resynchronize the contractions of the left ventricle (LV) leading to reduced mortality. Unfortunately, 30%–50% of patients do not respond to treatment when assessed by objective criteria such as cardiac remodeling. A significant contributing factor is the suboptimal placement of the LV lead. It has been shown that placing this lead away from scar and at the point of latest mechanical activation can improve response rates. This paper presents a comprehensive and highly automated system that us...
Source: IEE Transactions on Medical Imaging - Category: Biomedical Engineering Source Type: research
Cardiac resynchronisation therapy (CRT) is a cornerstone in the contemporary management of heart failure. The most effective way of predicting response to this therapy remains electrocardiographic (ECG) criteria of electromechanical dyssynchrony. The left bundle branch block (LBBB) pattern is currently the most robust ECG criterion in predicting improvement in symptoms and reduction in mortality. However, recent studies using three-dimensional (3D) mapping and cardiac magnetic resonance imaging (CMR) have demonstrated heterogeneous left ventricular activation patterns in patients with LBBB.
Source: Heart, Lung and Circulation - Category: Cardiology Authors: Tags: Review Source Type: research
Medtronic (NYSE:MDT) said today it won CE Mark approval in the European Union for its Attain Stability quad magnetic resonance imaging-safe left heart leads designed for cardiac resynchronization therapy defibrillators and pacemakers. The leads feature MRI SureScan technology and are cleared for use with 3 Tesla and 1.5T MRI scans, the Fridley, Minn.-based company said. The leads also feature a side-helix designed to be fixated in veins of various sizes, the company said. Medtronic said it has initiated a limited European launch, with the 1st commercial implants recently performed at Bergen, Norway’s Haukeland U...
Source: Mass Device - Category: Medical Devices Authors: Tags: Cardiac Implants Cardiovascular Regulatory/Compliance Medtronic Source Type: news
Biotronik said today it won FDA approval for its Intica DX and Intica cardiac resynchronization therapy CRT-DX implantable cardioverter defibrillator systems and that it launched the devices in the US. The Berlin-based company touted that the Intica line of ICD devices are the 1st to not require an atrial lead, normally used to monitor electrical activity in the atrium, as the system itself provides the necessary atrial signal information. Atrial diagnostics are used for the early detection of supraventricular tachycardia, atrial fibrillation and atrial ventricular synchronization. “When treating heart failure p...
Source: Mass Device - Category: Medical Devices Authors: Tags: Cardiac Assist Devices Cardiovascular Food & Drug Administration (FDA) Regulatory/Compliance Biotronik Source Type: news
Conclusion Retained CIED fragments are not associated with adverse events or increased mortality after OHT. Diagnostic MRI has been safely performed in patients with retained CIED fragments after incomplete device extraction. Retrieval of these fragments prior to MRI does not appear warranted given the demonstrated safety and preserved image quality in this population.
Source: American Heart Journal - Category: Cardiology Source Type: research
by Jun Kim, Jongmin Hwang, Jin Hee Choi, Hyo-In Choi, Min-Seok Kim, Sung-Ho Jung, Gi-Byoung Nam, Kee-Joon Choi, Jae Won Lee, You-Ho Kim, Jae-Joong Kim End-stage heart failure patients with implantable cardioverter-defibrillator (ICD) with/without cardiac resynchronization therapy (CRT-D) often require heart transplantation (HTPL) as a last-resort treatment. We aimed to assess the frequency and clinical impact of retained ICD lead materials in HT PL patients. In this retrospective single center study, we examined the clinical records and chest radiographs of patients with ICD and CRT-D who underwent HTPL between January 19...
Source: PLoS One - Category: Biomedical Science Authors: Source Type: research
Authors: Manolis AS Abstract INTRODUCTION: Risk stratification for sudden cardiac death in non-ischemic dilated cardiomyopathy (NIDCM) remains a clinical challenge. Areas Covered: Currently, left ventricular ejection fraction (LVEF), severity of heart failure symptoms according to NYHA classification, and morphology and duration of the QRS complex guide device management in these patients with implantation of a cardioverter defibrillator (ICD) and/or cardiac resynchronization therapy (CRT) devices. Recently, the results of a randomized trial stirred some controversy regarding the utility of ICD in NIDCM patients, h...
Source: Expert Review of Cardiovascular Therapy - Category: Cardiology Tags: Expert Rev Cardiovasc Ther Source Type: research
More News: Anatomy | Cardiac Resynchronization Therapy | Cardiology | Cardiovascular | Heart | Heart Failure | Hospitals | Medical Devices | MRI Scan