News | May 06, 2009

Endosense Receives CE Mark for its TactiCath Force Sensing Ablation Catheter

May 6, 2009 - Endosense said today it received the CE mark for its TactiCath system, reportedly the first force-sensing ablation catheter developed to gives physicians a real-time, objective measure of contact force during the catheter ablation procedure.

The CE mark allows physicians across Europe to use TactiCath in the treatment of supraventricular tachycardia (SVT) of the right atrium, the company said. The CE mark for TactiCath was granted based on select data submitted from Endosense’s TOCCATA (TOuCh+ for CATheter Ablation) clinical study, which was performed by 17 experienced investigators at eight European centers. During procedures on 42 enrolled SVT patients, the device was found to cause no serious adverse events, and the primary study endpoint was reached.

“The availability of the TactiCath marks an important advance in the field of catheter ablation,” said Karl-Heinz Kuck, M.D., Asklepios Klinik St. Georg, Hamburg, Germany, Endosense European scientific advisor and primary investigator of the TOCCATA trial. “The TactiCath is a critically important addition to our treatment armamentarium, as it will help to prevent perforation and identify sites of low contact force, which may lead to reconduction from the pulmonary veins in patients undergoing atrial fibrillation ablation.”

Acute data from the TOCCATA study will be presented at the Heart Rhythm Society’s 30th Annual Scientific Sessions May 13-16 in Boston.

Endosense plans to release the TactiCath system in Europe in the second half of 2009.

For more information: www.endosense.com

Related Content

Biotronik Announces U.S. Launch of Edora HF-T QP CRT Pacemaker
Technology | Cardiac Resynchronization Therapy Devices (CRT)| August 21, 2017
Biotronik announced U.S. Food and Drug Administration (FDA) approval and commercial availability of Edora HF-T QP, an...
The FDA is concerned about cybersecurity of ICDs and cyber security of other medical devices.
Feature | Cybersecurity| August 16, 2017 | Dave Fornell
There is growing concern among patients and regulators that medical devices, especially implantable electrophysiology
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...
Merge Hemo cath lab hemodynamics monitoring system.

Hemodynamic data shown on screens from the Merge Hemo recording system. It is among the newer generation hemodynamic systems for cath labs that are more user friendly and have technologies to speed workflow.

Feature | Hemodynamic Monitoring Systems| August 03, 2017 | Dave Fornell
The current generation of...
Left Atrial Pressure Monitor from Vectorious Medical Technologies Offers New Hope for Heart Failure Patients

On of the top stories in July was the introduction of a left atrial pressure monitor from Vectorious Medical Technologies to prevent heart failure patient hospitalizations or readmissions. Read the article"Left Atrial Pressure Monitor Offers New Hope for Heart Failure Patients."

Feature | August 01, 2017 | Dave Fornell
Aug.
Ohio State Researchers Prove Human Heart's 'Battery' Has Multiple Backups
News | EP Lab| July 27, 2017
July 27, 2017 — There is good news when it comes to the heart’s sinoatrial node (SAN), the body’s natural...
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...
Biotronik Launches DX Technology for U.S. Heart Failure Patients
News | Cardiac Resynchronization Therapy Devices (CRT)| July 21, 2017
Biotronik announced U.S. Food and Drug Administration (FDA) approval and availability of the Intica DX and Intica...
Overlay Init