FDA accepts CardioFocus' premarket application for endoscopically guided laser catheter

The FDA has accepted CardioFocus' (Marlborough, MA) premarket approval application for the company's HeartLight Endoscopic Ablation System (EAS) that treats atrial fibrillation (AF). The accepted application includes safety and effectiveness data from the company's multi-center HeartLight Pivotal Clinical Trial, a randomized, controlled study in which a total of 353 patients were treated at 19 leading arrhythmia centers across the U.S.

The HeartLight system allows surgeons to see what they are ablating inside the heart, according to Dr. Vivek Y. Reddy, senior author, co-principal investigator of the HeartLight U.S. pivotal trial, and Professor of Medicine and Director of Cardiac Arrhythmia Services at the Mount Sinai School of Medicine (New York, NY). Results from the clinical trial found that with increased operator experience, there was a significant improvement in fluoroscopy time and non-significant trends to improvement in procedure time, efficacy, and safety.

The U.S. clinical trial results add to existing clinical evidence, which includes nearly two dozen independent studies, supporting the HeartLight system. Several EU single-center studies have been published reporting high rates of freedom from AF recurrence measured one year after the performance of a single ablation procedure using the system. To date, the system has helped to treat more than 3000 patients worldwide.

Full results of the clinical trial appear in the Journal of the American College of Cardiology (JACC); for more information, please visit http://dx.doi.org/10.1016/j.jacc.2015.07.036.

Follow us on Twitter, 'like' us on Facebook, connect with us on Google+, and join our group on LinkedIn

Get All the BioOptics World News Delivered to Your Inbox

Subscribe to BioOptics World Magazine or email newsletter today at no cost and receive the latest news and information.

 Subscribe Now
Related Articles

FDA authorizes emergency use of Zika virus molecular detection assay

The xMAP MultiFLEX Zika RNA assay combines optofluidics and digital signal processing to detect Zika virus in vitro.

Merz acquires laser tattoo removal device maker ON Light Sciences

Merz North America has acquired ON Light Sciences, which develops technologies to enhance laser-based dermatology procedures.

Shortwave-infrared device could improve ear infection diagnosis

An otoscope-like device that could improve ear infection diagnosis uses shortwave-infrared light instead of visible light.

Laser therapy extracts rare tumor that grew human hair, skin in boy's skull

About four years ago, a tumor comprised of human skin, hair, bone and cartilage was fast-growing inside a Ramsey, MN, 10-year-old youth's brain.
BLOGS

Neuro15 exhibitors meet exacting demands: Part 2

Increasingly, neuroscientists are working with researchers in disciplines such as chemistry and p...

Why be free?

A successful career contributed to keeping OpticalRayTracer—an optical design software program—fr...

LASER Munich 2015 is bio-bent

LASER World of Photonics 2015 included the European Conferences on Biomedical Optics among its si...

White Papers

Understanding Optical Filters

Optical filters can be used to attenuate or enhance an image, transmit or reflect specific wavele...

How can I find the right digital camera for my microscopy application?

Nowadays, image processing is found in a wide range of optical microscopy applications. Examples ...

CONNECT WITH US

            

Twitter- BioOptics World

Copyright © 2007-2016. PennWell Corporation, Tulsa, OK. All Rights Reserved.PRIVACY POLICY | TERMS AND CONDITIONS