CardioFocus is looking to bring the next generation of its endoscopic ablation system to the market and that could happen sometime next year. The Marlborough, MA-based company and finalist in MD+DIâs Manufacturer of the Year Award in 2012, took bold steps on this front this past week by completing enrollment for a trial evaluating its HeartLight X3 System.
The HeartLight X3 System uses laser energy to create lines of scar tissue to block the abnormal electrical pathways that cause atrial fibrillation, the most common type of cardiac rhythm disorder.
Roughly 60 patients were treated with the HeartLight X3 System in the pivotal confirmatory trial with a one-month follow up. CardioFocusâs trial will evaluate time, safety, and acute outcomes using the HeartLight X3 System in the treatment of AFib as pivotal endpoints.
âWe anticipate submitting for regulatory approval in Europe in the first quarter of next year,â Omari Bouknight, president and Chief Commercial Officer, for CardioFocus, told MD+DI. âWe anticipate having approval in Europe sometime mid-2019. One the U.S. side of things, weâre currently in discussions with FDA on what the submission will require. Weâre still in conversations with them in terms of what the regulatory path is, so we donât have a strict timeline for approval in the U.S. Weâll probably have a go…
ConclusionProtocol optimization and technological advances both contributed to significantly lower radiation dose and contrast volume used in cardiac CT prior to AF ablation, without compromising image quality.ResumoIntroduçãoA capacidade de a TC cardíaca fornecer um mapa anatómico preciso e excluir a presença de trombo intracardíaco é conhecida. O objetivo deste estudo foi avaliar o impacto da otimização de protocolos e evolução tecnológica nas doses de radiação e contraste e na qualidade de imagem dos exames de TC card&iacut…
People with the highest levels of salt in their diet had a higher rate of atrial fibrillation than those with the lowest salt intake in a new study.
Authors: Ibrahim A, Walsh LG, Algaali M, Satti Z, Kiernan TJ, Yan BP
INTRODUCTION: Direct oral anticoagulants (DOACs) have gained momentum in recent years in patients requiring anticoagulation for the prevention and management of venous thromboembolism and thromboembolic events caused by atrial fibrillation. The use of these agents involves potential bleeding complications, particularly during invasive procedures. With increasing use of DOACs, adequate knowledge regarding the perioperative management of patients on DOACs has become indispensable. Areas covered: This review covers the indications, mechanism…
Reva Medical (ASX:RVA) CEO Reggie Groves got her start in the medical device industry at medtech titan Medtronic. In her upcoming keynote interview at DeviceTalks West, Groves will discuss how that experience has shaped her as a leader and an innovator. Here’s a preview:
When Reggie Groves joined Medtronic (NYSE:MDT) in 2002, she didn’t know very much about the medical device industry. That was by design, she told MassDevice – the company was looking for somebody outside of the medtech world to launch their CareLink Network. It was the world’s first remote monitoring system designed to lin…
Top 3 AF Studies in 2018
Payal Kohli, MD, FACC
Every year, during the holidays, I look back on the exciting new discoveries in the world of atrial fibrillation and I am always amazed at all the ways in which our clinical practice continues to evolve as a result of these breakthroughs. This year, I selected three to highlight with my commentary on why I believe they are so meaningful.
#1) Antidote for Factor Xa inhibitors: Approved.
Andexxa, CABANA, and new AF score. Cardiologist and Patient Care author Payal Kohli, MD, highlights 3 pivotal developments from 2018.
This study looked at the impact of receiving an EHR popup on anticoagulation prescribing.
Authors: Westerman S, Wenger N
Atrial fibrillation is the most common sustained cardiac arrhythmia. The scope and impact of atrial fibrillation is wide; it can affect cardiac function, functional status, and quality of life, and it confers a stroke risk. There are sex differences in atrial fibrillation across the scope of the disease process, from epidemiology and causative mechanisms to management and outcomes. The approach to management of atrial fibrillation differs between women and men, and there are sex differences in response to medical therapy and catheter ablation. There are many gaps in our knowl…
Patients with warfarin have a potential risk of warfarin-related nephropathy, which could result in the discontinuation of anticoagulation therapy. The question of whether non-vitamin K antagonist oral anticoagulants (NOACs) use is associated with increased risk of renal impairment in atrial fibrillation (AF) patients remains unanswered.
Cardiac fibrosis (CF), a process characterized by potentiated proliferation of cardiac fibroblasts and excessive secretion and deposition of extracellular matrix (ECM) from the cells, contributes strongly to the pathogenesis of a series of cardiovascular (CV) diseases, including AMI, heart failure and atrial fibrillation. Endothelial-mesenchymal transition (EndMT), one of the sources of transformed cardiac fibroblasts, has been reported as a key factor involved in CF. However, the molecular basis of EndMT has not been thoroughly elucidated to date.