News | May 13, 2013

First Patient Enrolled in Study Evaluating the Multi-Electrode nMARQ Pulmonary Vein Isolation System

System may aid treatment of paroxysmal atrial fibrillation

BioSense Webster eMARQable Clinical Study nMARQ System Atrial Fibrillation

May 13, 2013 — Biosense Webster Inc. announced the first patient has been enrolled in the reMARQable clinical study. ReMARQable will assess the safety and efficacy of the use of the nMARQ Pulmonary Vein Isolation System to treat paroxysmal atrial fibrillation. Atrial fibrillation (Afib) is a heart rhythm disorder that affects approximately 20 million people worldwide.

Texas Cardiac Arrhythmia Institute (TCAI) at St. David’s Medical Center was first facility in the United States to use the nMARQ System to treat paroxysmal Afib as part of the clinical study. Andrea Natale, M.D., FHRS, FACC, FESC, cardiac electrophysiologist and executive medical director of TCAI, performed the first case in the United States, and was among the first to use this new catheter in Europe. “I am encouraged by the possibilities of this new system,” said Natale. “This technology could provide another tool to more effectively treat patients with paroxysmal Afib.”

“We are excited about the start of the pivotal U.S. clinical trial for this innovative new technology,” said Shlomi Nachman, worldwide president, Biosense Webster, Inc. “By combining the multi-ablation capability of nMARQ System with the proven irrigation technology and the unparalleled mapping accuracy of the CARTO 3 System, this new platform has been designed to reduce procedure time and complexity.”

The nMARQ System consists of a multi-electrode, irrigated catheter ablation system. Each nMARQ Catheter has 10 irrigation holes per electrode completely surrounding the electrodes. The reMARQable trial will enroll approximately 400 patients at up to 50 sites in the U.S. The study is being conducted under a U.S. Food and Drug Administration (FDA)-approved Investigational Device Exemption, and the new catheter is not available in the United States outside of the reMARQable study. Further information is available at: http://clinicaltrials.gov/ct2/show/NCT01824394?term=remarqable&rank=1.

For more information: www.biosensewebster.com


Related Content

News

May 15, 2024 —CardioFocus, Inc., a medical device company dedicated to advancing ablation treatment for cardiac ...

Home May 15, 2024
Home
News

May 13, 2024 — Innovative Health, Inc. announced that recent growth in single-use device reprocessing has delivered ...

Home May 13, 2024
Home
News

October 10, 2023 — Axon Therapies, a private company focused on addressing a root cause of heart failure, announced 6 ...

Home October 10, 2023
Home
News

August 9, 2023 — Boston Scientific Corporation announced it has received U.S. Food and Drug Administration (FDA) ...

Home August 09, 2023
Home
News

January 31, 2023 —Imricor, a global leader in real-time interventional cardiac magnetic resonance (iCMR) ablation ...

Home January 31, 2023
Home
News

December 21, 2022 — Stereotaxis, a global leader in robotic technologies for the treatment of cardiac arrhythmias ...

Home December 21, 2022
Home
News

October 24, 2022 — Acutus Medical, Inc, an arrhythmia management company focused on improving the way cardiac ...

Home October 24, 2022
Home
News

May 13, 2022 — Acutus Medical, an arrhythmia management company focused on improving the way cardiac arrhythmias are ...

Home May 13, 2022
Home
News

May 4, 2022 – Stereotaxis, the global leader in innovative robotic technologies for the treatment of cardiac arrhythmias ...

Home May 04, 2022
Home
News

April 5, 2021 — Acutus Medical today announced initial U.S. enrollments in the company’s AcQForce Flutter ...

Home April 05, 2021
Home
Subscribe Now