Biosense Webster, Inc. Launches Outcomes-Based, Risk-Sharing Program to Reinforce Significant Patient Benefits Demonstrated by Company’s Leading Contact Force Therapy

DIAMOND BAR, Calif.--()--Biosense Webster, Inc., a worldwide leader in the diagnosis and treatment of cardiac arrhythmias, announced the launch of the BIOSENSE WEBSTER ADVANTAGESM Program, an outcomes-based, risk-sharing program for U.S. hospitals that reinforces the significant patient benefits demonstrated by the company’s THERMOCOOL SMARTTOUCH® Catheter. This is the first therapy approved by the U.S. Food and Drug Administration (FDA) to enable direct and real-time measurement of contact force during catheter ablation and the only integrated catheter in the world that can provide stability of contact force.1

All U.S.-based hospitals are eligible to participate in the BIOSENSE WEBSTER ADVANTAGESM Program and enrollment is open to patients with paroxysmal, drug-resistant atrial fibrillation (Afib) treated with the THERMOCOOL SMARTTOUCH® Catheter. Participating hospitals will be guaranteed a credit if an enrolled patient returns for a repeat procedure within 12 months.

“We are pleased to announce availability of the BIOSENSE WEBSTER ADVANTAGESM Program for all U.S. hospitals after receiving extremely positive feedback from an initial pilot of the program,” said David Shepherd, Worldwide President of Biosense Webster. “This novel program is backed by our confidence in the THERMOCOOL SMARTTOUCH® Catheter, which is seamlessly integrated with our CARTO® SMARTTOUCH™ 3D Module, and has demonstrated compelling clinical outcomes in our SMART-AF Trial that studied this therapy. This program aligns with broader efforts in the U.S. to improve health outcomes, increase patient satisfaction, and lower costs – known as the ‘Triple Aim’ of health care.”

An estimated three million people in the U.S. and 20 million worldwide are affected by Afib and it is a leading cause of strokes among people 65 years and older.3 Afib is estimated to be responsible for 88,000 deaths and $16 billion in additional costs to the U.S. health care system on an annual basis.4

“Biosense Webster’s risk-sharing program demonstrates the company’s commitment to exploring unique partnerships with hospitals as we look to optimize clinical outcomes, decrease cost and enhance the overall patient experience,” said Dr. Reginald Blaber, FACC, Executive Director and Vice President of Cardiovascular Services at Lourdes Health System. “This novel program facilitates easier access to this latest treatment advancement as it mitigates some of the economic risk we traditionally absorbed on our own.”

The SMART-AF Trial evaluated the safety and effectiveness of the THERMOCOOL SMARTTOUCH® Catheter in patients with drug-resistant paroxysmal atrial fibrillation. One-year results from the trial, recently published in the Journal of the American College of Cardiology, showed patients experienced an overall success rate of 74 percent.2 Importantly, a subanalysis from the trial demonstrated an 88 percent success rate when contact force was within an investigator-selected range greater than or equal to 85 percent of time.* This trial demonstrated for the first time that stability of contact force therapy helps to significantly improve outcomes for patients undergoing catheter ablation. This data reinforces the growing body of clinical evidence demonstrating that stability of contact force helps physicians deliver tailored treatment with precision and accuracy, ensuring very positive clinical outcomes.

“The THERMOCOOL SMARTTOUCH® Catheter has set a new standard in cardiac arrhythmia management by providing the confidence that every location I need to ablate is effectively treated the first time,” said Dr. Craig Delaughter, HeartPlace Baylor All Saints. “This therapy represents a significant advancement as it has proven results in improving clinical outcomes for patients with atrial fibrillation and helping them get back to their lives.”

The THERMOCOOL SMARTTOUCH® Catheter was approved by the FDA in February of this year and is indicated for patients suffering from drug-resistant paroxysmal atrial fibrillation (Afib), sustained monomorphic ischemic ventricular tachycardia and Type I atrial flutter.

About Atrial Fibrillation and Contact Force Therapy

Afib is the most common heart rhythm disorder in the world and its prevalence is expected to increase significantly as the population ages. Left untreated, it can lead to heart valve disease, sleep apnea, chronic fatigue, congestive heart failure and stroke. During contact force therapy, doctors insert a therapeutic catheter through a small incision in the groin where it is then weaved up to the heart through a blood vessel in the leg. Once it reaches the upper left chamber of the heart, an advanced 3D map guides the controlled application of contact force therapy around the openings of the pulmonary veins. This advanced technology enables doctors to precisely and accurately control how much pressure they’re applying against the heart wall to ensure optimal outcomes. The lesions that are created work to isolate and prevent the abnormal electrical signals originating from those pulmonary veins from reaching the rest of the heart.

About Biosense Webster, Inc.

Biosense Webster, Inc. is the global leader in the science of diagnosing and treating heart rhythm disorders. The company partners with clinicians to develop innovative technologies that improve the quality of care for arrhythmia patients worldwide. Biosense Webster, Inc. is part of the Johnson & Johnson Family of Companies. More information can be found at www.biosensewebster.com.

1. The THERMOCOOL SMARTTOUCH® Catheters provide a real-time measurement of contact force between the catheter tip and heart wall, as well as location information when used with CARTO® 3 Navigation System. THERMOCOOL® Navigation Catheters are approved for drug refractory recurrent symptomatic paroxysmal Afib, when used with CARTO® Systems (excluding NAVISTAR® RMT THERMOCOOL® Catheter).

2. Natale A, Reddy VY, Monir G, et al. Paroxysmal AF catheter ablation with a contact force sensing catheter: results of the prospective, multicenter SMART AF trial. J Am Coll Cardiol 2014;64:647–56.

3. Naccarelli GV, Varker H, Lin J, Schulman KL. Increasing prevalence of atrial fibrillation and flutter in the United States. Am J Cardiol.2009;104:1534-1539.

4. Kim MH, Johnston SS, Chu BC, Dalal MR, Schulman KL. Estimation of total incremental health care costs in patients with atrial fibrillation in the United States.Circ Cardiovasc Qual Outcomes 2011;4:313–320.25

*Success defined as freedom from any symptomatic atrial arrhythmia (atrial fibrillation, atrial flutter, atrial tachycardia) 12 months postprocedure when operator remained in the preset contact force range. Further sub-analysis showed that when the contact force was within investigator-selected range ≥85% of time, success rate increased by 21% to 88% (≥85%: n=32; <85%: n=73).

Third party trademarks used herein are trademarks of their respective owners.

Dr. Delaughter has previously served as a paid consultant to Biosense Webster, Inc.

Contacts

Janet Kim, 909-839-7275
jkim50@its.jnj.com

Contacts

Janet Kim, 909-839-7275
jkim50@its.jnj.com