News | Cardiovascular Clinical Studies | March 15, 2018

Patient Enrollment Completed in U.S. IDE Study of THERMOCOOL SMARTTOUCH SF Catheter

The catheter will treat persistent atrial fibrillation

 

Patient Enrollment Completed in U.S. IDE Study of THERMOCOOL SMARTTOUCH SF Catheter

March 15, 2018 –  Johnson & Johnson Medical Devices Companies announced today that Biosense Webster, Inc., who works in the diagnosis and treatment of heart arrhythmias, has completed patient enrollment in its U.S. Investigational Device Exemption (IDE) study of the THERMOCOOL SMARTTOUCH SF Catheter. The prospective, multicenter, non-randomized study of 367 patients is evaluating the device for the treatment of persistent atrial fibrillation (AF), an irregular heartbeat that lasts beyond seven days.

The THERMOCOOL SMARTTOUCH SF Catheter, the most widely used ablation catheter on the market, was launched in 2016 in the United States to treat symptomatic, drug-refractory, paroxysmal AF, an intermittent AF that resolves within a week. The device combines contact force technology and a porous tip to optimize efficiency by providing uniform cooling at half the flow rate of earlier generation irrigated catheters, which eases the fluid management process.

“This is an important study that may lead to a new option for persistent AF patients in the United States who are unable to control their abnormal heart rhythm with drugs or tolerate the side effects these drugs can sometimes produce,” said Moussa Mansour, M.D., Director, Atrial Fibrillation Program, Massachusetts General Hospital (MGH) in Boston. “We’ve already seen very good results with the device in patients with paroxysmal AF and are now assessing whether it is beneficial to a wider patient population.”

AF is the most common heart rhythm disorder and a leading cause of stroke among people 65 years and older. An estimated 3 million people in the U.S. and 20 million worldwide are affected. Left untreated, AF can lead to stroke, chronic fatigue, congestive heart failure and additional heart rhythm problems.

“Catheter ablation is increasingly being offered to patients with atrial fibrillation based on the growing evidence supporting the procedure,” said Andrea Natale, M.D., Executive Medical Director, Texas Cardiac Arrhythmia Institute at St. David’s Medical Center. “This study will add to our knowledge and potentially lead to greater adoption of RF ablation as a viable treatment option for patients with persistent AF.”

For more information: www.biosensewebster.com

Related Content

Medtronic Cryoballoon Shows Positive Results for Patients With Persistent Atrial Fibrillation
News | Ablation Systems | April 12, 2018
Medtronic plc announced one-year results from the CRYO4PERSISTENT AF study of ablation with the Arctic Front Advance...
Boston Scientific Acquires Securus Medical Group Inc.
News | Ablation Systems | April 04, 2018
Boston Scientific Corp. announced the acquisition of Securus Medical Group Inc., a privately-held company that has...
Stereotaxis Receives Regulatory Approval of e-Contact Module in Canada
Technology | Ablation Systems | December 08, 2017
December 7, 2017 — Stereotaxis Inc.
CardioFocus Announces European CE Mark Approval of HeartLight Excalibur Balloon
Technology | Ablation Systems | October 10, 2017
October 10, 2017 — CardioFocus Inc. recently announced the European CE Mark approval of the HeartLight Excalibur Ball
The Apama Radiofrequency (RF) Balloon Catheter System.
News | Ablation Systems | October 02, 2017
October 2, 2017 — Boston Scientific announced a definitive agreement to acquire Apama Medical Inc., a privately-held
Three New Atrial Fibrillation Studies to Feature HeartLight Endoscopic Ablation System
News | Ablation Systems | August 07, 2017
CardioFocus Inc. announced that its HeartLight Endoscopic Ablation System is being featured in three new major clinical...
Medtronic Announces First Enrollments in STOP AF First Clinical Trial
News | Ablation Systems | July 24, 2017
Medtronic plc recently announced first enrollments in the STOP AF First clinical trial. The trial will evaluate the...
Biosense Webster multi-electrode RF ablation balloon

Biosense Webster's multi-electrode RF ablation balloon with irrigation. The system allows operators to change the energy levels of each electrode to avoid damaging sensitive underlying critical structures like the esophagus or phrenic nerve.

Feature | Ablation Systems | May 17, 2017 | Dave Fornell
May 17, 2017 – Clinical trial results from a first-in-human study evaluating the acute feasibility of an investigatio
Abbott Announces CE Mark for New Cardiac Ablation Catheter
News | Ablation Systems | May 10, 2017
Abbott announced CE Mark of the TactiCath Contact Force Ablation Catheter, Sensor Enabled, developed to make it easier...
Medtronic, expanded indication, Freezor Xtra Cryoablation Catheter, AVNRT, atrioventricular nodal re-entrant tachycardia
Technology | Ablation Systems | February 16, 2017
Medtronic plc announced the U.S. Food and Drug Administration (FDA) has approved its Freezor Xtra Cryoablation Catheter...
Overlay Init