News | May 14, 2012

Endosense Reports Strong Interest in Ablation Contact-Force Sensing

Expansive body of data and professional consensus statement mark progress in the field

May 14, 2012 – Endosense said there has been strong interest and significant advancement in the move toward making contact-force sensing a standard-of-care in catheter ablation procedures. Participating at the Heart Rhythm (HRS) 2012 meeting last week in Boston, the company noted a wealth of new clinical abstracts and a new HRS/EHRA/ECAS consensus statement as key validation points supporting the value of the sensory parameter in cardiac ablation.

Among the clinical data presented at Heart Rhythm 2012 were more than 20 abstracts exploring the use of contact-force sensing during catheter ablation procedures; these abstracts build on more than 50 clinical papers and presentations on the subject since 2010 alone. Fourteen of the new Heart Rhythm 2012 abstracts featured Endosense’s TactiCath, the first force-sensing catheter to give the electrophysiologist a real-time, objective measure of contact force during the catheter ablation procedure.

Key new data on the TactiCath included the results of Endosense’s EFFICAS II clinical study, presented by Dr. Josef Kautzner (Prague, Czech Republic) in “Contact Force, FTI [Force Time Integral] and Lesion Continuity Are Critical to Improve Durable PV Isolation: EFFICAS II Results.” The data showed that contiguous lesions created following the Contact Force Guidelines identified in EFFICAS I (CF above 10 g and FTI above 400 gs) resulted in superior ablation outcomes, with durable pulmonary vein isolation of up to 98 percent found at three months via invasive follow-up. Several other studies presented showed the importance of FTI as a determinant for ablation success or for a reduction of procedure time.

Additional force sensing-related topics discussed at the Heart Rhythm meeting include the 2012 HRS/EHRA/ECAS Expert Consensus Statement on Catheter and Surgical Ablation of Atrial Fibrillation, which was released in March. For the first time, the consensus statement recognizes contact-force sensing as a parameter that has the potential to improve the efficacy and safety of catheter ablation procedures.

“The field of contact-force sensing is clearly experiencing tremendous momentum, as more and more scientific evidence and clinical use point to its value in improving outcomes and shortening procedure times of catheter ablation procedures,” said Jan Keltjens, Endosense president and chief executive officer. “Endosense is proud to have pioneered the concept of contact-force sensing in catheter ablation and to have also validated it with the groundbreaking TOCCATA and EFFICAS studies, and we are very pleased to remain at the forefront of this exciting field today.”

Endosense’s leadership in the field of contact-force sensing dates back to the first abstract on the TactiCath at Heart Rhythm 2006. Since that time, the company has conducted a number of clinical studies demonstrating the safety and effectiveness of contact-force sensing over traditional ablation technologies, and has also nearly completed enrollment in the pivotal TOCCASTAR investigational device exemption clinical trial.  

Biosense Webster also showed its version of force sensing catheters at its booth during HRS 2012. The company showed its CE-marked Smart Touch system, which is in its final follow up phase of its investigational device exemption (IDE) trial in the United States. The company hopes to submit the device for final U.S. Food and Drug Administration review in 2013. 

Smart Touch uses a force sensing system based on pressure applied to the tip, which integrates a nitinol spring and pressure sensor. The system was developed to integrate with the Biosense Carto3 mapping system.

For more information:



Related Content

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...
CardioFocus, HeartLight Excalibur Balloon, 22nd Annual AF Symposium, atrial fibrillation, initial clinical evaluation
News | Ablation Systems | January 25, 2017
CardioFocus Inc. recently announced the initial clinical evaluation of the HeartLight Excalibur Balloon, a next-...
catheter ablations, atrial fibrillation, stroke risk, Intermountain Medical Center Heart Institute study, AHA Scientific Sessions, American Heart Association
News | Ablation Systems | November 14, 2016
Atrial fibrillation patients with a prior history of stroke who undergo catheter ablation lower their long-term risk of...
Overlay Init