Electrophysiology News and Research

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BIOTRONIK announces FDA IDE approval and first patient enrollment for TOCCASTAR clinical trial

BIOTRONIK SE Co. & KG highlights two key milestones toward receiving premarket approval (PMA) of the TactiCath, a novel technology for treating atrial fibrillation (AF): FDA IDE (investigational device exemption) approval and the first patient enrollment of the TOCCASTAR (TactiCath Contact Force Ablation Catheter Study for Atrial Fibrillation) clinical trial.

14 Jan 2011

FDA accepts Merck's JANUMET extended-release formulation NDA for type 2 diabetes

Merck today announced that the New Drug Application (NDA) for the Company's investigational extended-release formulation of JANUMET for type 2 diabetes has been accepted for standard review by the U.S. Food and Drug Administration (FDA). The Company is also moving forward as planned with regulatory filings in countries outside the United States.

12 Jan 2011

Stereotaxis announces first successful cardiac ablation procedure with Vdrive robotic navigation system

Stereotaxis, Inc. announces the first successful cardiac ablation procedure with the Vdrive™ robotic navigation system as the company received CE Mark for this latest innovation.

11 Jan 2011

Baylor Hamilton offers Arctic Front Cardiac CryoAblation Catheter system treatment for paroxysmal atrial fibrillation

Physicians at Baylor Jack and Jane Hamilton Heart and Vascular Hospital are the first in North Texas to offer the Arctic Front® Cardiac CryoAblation Catheter system, the first and only cryoballoon in the United States indicated to treat drug refractory recurrent symptomatic paroxysmal atrial fibrillation (PAF), a serious heart rhythm disorder that affects millions of Americans.

11 Jan 2011

nContact Surgical removes 'Surgical' from company name

nContact Surgical, Inc., a cardiac ablation device manufacturer, announced today that it is changing the name under which it operates from nContact Surgical, Inc. to nContact, Inc. As the pioneer of interdisciplinary epicardial and endocardial cardiac ablation, the change represents the Company's further evolution towards closed chest approaches to treating common cardiac arrhythmias.

10 Jan 2011

$FDA approves Medtronic's Arctic Front Cardiac CryoAblation Catheter system for drug refractory PAF$

FDA approves Medtronic's Arctic Front Cardiac CryoAblation Catheter system for drug refractory PAF

Medtronic, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved its Arctic Front® Cardiac CryoAblation Catheter system, the first and only Cryoballoon in the United States indicated for the treatment of drug refractory paroxysmal atrial fibrillation (PAF). The Cryoballoon treatment involves a minimally-invasive procedure that efficiently creates circumferential lesions around the pulmonary vein, which is the source of erratic electrical signals that cause the irregular heartbeat.

20 Dec 2010

LUMEDX implements CardioInventory software at Iowa Health Systems' affiliate hospitals

LUMEDX Corporation, a leading provider of vendor-neutral, integrated cardiovascular imaging and information systems (CVIS), announced the successful implementation of CardioInventory at nine Iowa Health Systems (IHS) affiliate hospitals. The final go-live at St. Luke's Medical Center in Cedar Rapids represents an important milestone in the ongoing installation of a centralized, enterprise-wide LUMEDX cardiovascular image- and data-management system for Iowa Health System.

9 Dec 2010

St. Jude Medical announces advanced technologies for streamlined workflow in EP lab

St. Jude Medical, Inc., a global medical device company, today announced several new products that provide physicians and hospitals with the opportunity for improved efficiency and information connectivity in the electrophysiology (EP) lab. The EnSite Connect™ Remote Support feature, EnSite Courier™ Module, EnSite Velocity v2.0™ Software and recently launched EnSite Derexi™ Module are advanced technologies that allow a streamlined workflow within the EP lab.

9 Dec 2010

Stereotaxis awarded VA Federal Supply Schedule Contract for Niobe Remote Magnetic Navigation System

Stereotaxis, Inc. announced that the United States Department of Veteran Affairs awarded Stereotaxis a Federal Supply Schedule Contract for its Niobe® Remote Magnetic Navigation System, related service agreement, and disposable products. This contract, effective December 15, 2010, is for five years, with a five year renewal option.

7 Dec 2010

Sentara Heart Hospital commences procedures in AtriCure DEEP AF feasibility trial

Sentara Heart Hospital is breaking new ground in cardiac care and treatment. Surgeons and Cardiologists at Sentara Heart Hospital are first to begin enrolling and performing trial cases in the AtriCure DEEP AF feasibility trial. The first procedure in the country was performed in a new, state-of-the-art hybrid operating room at Sentara Heart Hospital by Jonathan Philpott, M.D., Director of the Sentara Atrial Fibrillation Surgery Program, Ian Woollett, M.D., and John Onufer, M.D., Medical Director of Cardiac Electrophysiology.

3 Dec 2010

AtriCure initiates enrollment in DEEP AF feasibility trial

AtriCure, Inc., a medical device company and a leader in cardiac surgical ablation systems and systems for the exclusion of the left atrial appendage, announced initial patient enrollment in its DEEP AF feasibility trial. The first procedure was performed in a new, state-of-the-art hybrid room at Sentara Norfolk General Hospital in Norfolk, Virginia by Jonathan Philpott, M.D., Director of the Sentara Atrial Fibrillation Surgery Program, Ian Woollett, M.D., and John Onufer, M.D., Medical Director of Cardiac Electrophysiology.

3 Dec 2010

Daiichi Sankyo completes patient enrollment in Phase III edoxaban study for AF

Daiichi Sankyo Company, Limited (TSE: 4568) announced today that it has successfully completed patient enrollment for its Phase III ENGAGE AF-TIMI 48 clinical study of edoxaban, a direct, specific, oral Factor Xa inhibitor that is being investigated in two different dosing regimens given once daily, to prevent the occurrence of strokes and systemic embolic events (SEE) in patients with atrial fibrillation (AF).

2 Dec 2010

Budapest meeting to highlight discrepancies in using implantable devices among European countries

Even though the use of implantable devices for the treatment of heart failure and heart rhythm disturbances has increased enormously in Europe in recent years, there still remain large differences between countries. Indeed, a report last year in the European Journal of Heart Failure found that there is an underuse of devices in many of the European countries surveyed. This is especially so in the emerging economies of Eastern Europe.

23 Nov 2010

New editorial dispel doubts about Lou Gehrig's ALS diagnosis

A recent study suggesting that amyotrophic lateral sclerosis (ALS) may be attributed to repetitive head trauma experienced in collision sports lacks scientific epidemiological evidence to support this claim.

20 Nov 2010

Insertable cardiac monitors may help physicians diagnose, treat patient with syncope: PICTURE trial

Medtronic, Inc. today announced the publication of data showing that use of its Reveal family of Insertable Cardiac Monitors led to diagnosis and specific treatment for 78 percent (170 of 218) of patients who experienced a recurrent syncopal (fainting) event during the course of the study.

20 Nov 2010

NAVISTAR THERMOCOOL Catheter improves quality of life in patients with atrial fibrillation

According to data appearing today in Circulation Cardiovascular Quality and Outcomes, patients with a common heart rhythm disorder, called atrial fibrillation, who were treated with catheter ablation using the NAVISTAR THERMOCOOL Catheter, reported markedly fewer symptoms and substantially improved quality of life than patients treated with antiarrhythmia drugs at one year.

18 Nov 2010

Gene transfer reduces and stabilizes plaque and decreases inflammation

A plaque-fighting gene - studied in various forms by researchers at the Cedars-Sinai Heart Institute for 18 years - has now been transferred intravenously to lab mice bred to model atherosclerosis (clogged arteries) in humans. Studies show the gene transfer reduced and stabilized plaque and decreased inflammation, key factors in cutting the risk of heart disease.

18 Nov 2010

St. Jude Medical and ZONARE enter partnership in ultrasound imaging

St. Jude Medical, Inc., a global medical device company and ZONARE Medical Systems, a leading provider of premium ultrasound systems, today announced they have entered into a development and marketing agreement. Under this agreement, the companies will combine the St. Jude Medical intracardiac echocardiography (ICE) catheter and the ZONARE z.one Convertible Ultrasound system technology, and co-market an ultrasound system for intracardiac (inside the heart) imaging.

17 Nov 2010

Anti-stroke blood thinner shows promise in large clinical trials

In new and extensive clinical trials an experimental blood thinner called rivaroxaban is at least as good at preventing strokes as the drug warfarin – that has been the most widely used agent for the past five decades in people with erratic heartbeats called atrial fibrillations. Researchers said this Monday that this drug also sharply reduces the risk of major bleeding that is seen with warfarin.

16 Nov 2010

World's first remote heart procedure using robotic arm alongside 3-D mapping

The world's first remote heart procedure, using a robotic arm alongside 3-D mapping, is due to take place at Glenfield Hospital in Leicester.

15 Nov 2010