News | Ablation Systems | February 04, 2019

First Patient Treated With QDot Micro Ablation Catheter

Treatment marks kickoff of U.S. IDE study evaluating RF catheter in the treatment of symptomatic drug-refractory paroxysmal atrial fibrillation

First Patient Treated With QDot Micro Ablation Catheter

February 4, 2019 – Biosense Webster has enrolled and treated the first patient in its U.S. Investigational Device Exemption (IDE) study evaluating the company’s QDot Micro radiofrequency (RF) ablation catheter in the treatment of symptomatic drug-refractory paroxysmal atrial fibrillation (AF). The first AF patient was treated at NYU Langone Health’s Heart Rhythm Center in New York City, one of up to 30 centers participating in the study that will enroll up to 185 patients throughout the U.S.

“The delivery of 90 watts of RF power in a short, four-second ablation session is a significant advancement in the treatment of paroxysmal atrial fibrillation,” said Larry A. Chinitz, M.D., electrophysiologist and director of the Heart Rhythm Center at NYU Langone Health, who treated the first patient in the study.+ “We’re eager to see whether this new technology helps to reduce procedure time and improve clinical outcomes.”

Current catheter technologies typically deliver RF ablation at an average power level between 20 and 40 watts and for a duration of 20 to 40 seconds.[1] The QDot Micro RF Ablation Catheter, which is only available for investigational use in the United States, is the first to deliver 90 watts of RF power in a short, four-second temperature-controlled session. Its temperature control and micro-electrode technology is specifically designed to provide more efficient and consistent lesion creation with advanced diagnostics.

An estimated 33 million people worldwide have been diagnosed with AF and its prevalence is projected to increase significantly as the population ages.[2] Approximately 70 percent of patients with AF are between the ages of 65 and 85.[3]  

The QDot Micro IDE follows the commencement of the STELLAR U.S. IDE study in November. That trial will evaluate the safety and effectiveness of the Heliostar Multi-electrode Radiofrequency Balloon Ablation Catheter in treating symptomatic drug refractory recurrent paroxysmal (intermittent) atrial fibrillation.

For more information: www.biosensewebster.com

References

[1] https://link.springer.com/article/10.1007/s10840-018-0322-6

[2] European Heart Journal, Volume 37, Issue 38, 7 October 2016, Pages 2893–2962, https://doi.org/10.1093/eurheartj/ehw210

[3] Amin A, Houmsse A, Ishola A, Tyler J, Houmsse M. The current approach of atrial fibrillation management. Avicenna J Med. 2016 Jan-Mar; 6(1): 8–16.

 

Related Content

CardioFocus Announces European CE Mark Approval Of HeartLight X3 System
News | Ablation Systems | April 16, 2019
CardioFocus Inc. announced the European CE Mark approval of the HeartLight X3 Endoscopic Ablation System.
FDA Approves TactiCath Contact Force Ablation Catheter, Sensor Enabled
Technology | Ablation Systems | January 21, 2019
Abbott announced U.S. Food and Drug Administration (FDA) approval of the TactiCath Contact Force Ablation Catheter,...
First Patient Treated in STELLAR Atrial Fibrillation IDE Study
News | Ablation Systems | November 30, 2018
Johnson & Johnson Medical Devices Companies announced that Biosense Webster Inc. has enrolled and treated the first...
FDA Approves Biosense Webster's Tag-Index Guided Ablation Software
Technology | Ablation Systems | October 09, 2018
Biosense Webster Inc. recently received approval from the U.S. Food and Drug Administration (FDA) for its Visitag...
Medtronic Cryoballoon Improves Quality of Life, Reduces Systems of Persistent Atrial Fibrillation
News | Ablation Systems | August 28, 2018
Medtronic plc announced new findings from the CRYO4PERSISTENT AF clinical trial demonstrating improved quality of life...
Thermedical Announces FDA IDE Approval for Clinical Study of Durablate Catheter
News | Ablation Systems | August 02, 2018
Thermedical announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational Device...
Boston Scientific to Acquire Cryterion Medical Inc.
News | Ablation Systems | July 13, 2018
Boston Scientific Corp. recently announced a definitive agreement to acquire Cryterion Medical Inc., a privately-held...
Treating AFib With Ablation Reduces Mortality and Stroke
News | Ablation Systems | July 05, 2018
Using catheter-based ablation instead of medications alone reduces the risks of death and stroke in patients with the...
LuxCath Showcases OmniView Light-Guided Ablation Catheter at HRS 2018
News | Ablation Systems | May 22, 2018
LuxCath LLC showcased the next generation of its proprietary OmniView light-guided catheter ablation system at the 2018...
The Kardium Globe combined mapping and ablation catheter. The device has a distal multi-electrode array consisting of 16 ribs with 122 gold-plated electrodes. Ablation can be done with up to 24 electrodes simultaneously.  #HRS2018

The Kardium Globe combined mapping and ablation catheter. The device has a distal multi-electrode array consisting of 16 ribs with 122 gold-plated electrodes. Ablation can be done with up to 24 electrodes simultaneously. 

News | Ablation Systems | May 21, 2018
May 21, 2018 — Complete pulmonary vein isolation (PVI) was achieved in more than 99 percent of patients in a first-in
Overlay Init