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CORRECTING and REPLACING Biosense Webster Teams Up with StopAfib.org to Challenge Americans to Get SMART About AfibSM

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Fourth paragraph, first sentence of release should read: Earlier this year, the U.S. Food and Drug Administration approved the THERMOCOOL(R) SMARTTOUCH(R) Catheter, the first contact force therapy available in the U.S. (Instead of Earlier this year, the U.S. Food and Drug Administration approved the THERMOCOOL(R) SMARTTOUCH(R) Catheter, the first and only contact force…).

The corrected release reads:

BIOSENSE WEBSTER TEAMS UP WITH STOPAFIB.ORG TO CHALLENGE AMERICANS TO GET SMART ABOUT AFIBSM

Biosense Webster, Inc., a worldwide leader in the diagnosis and treatment of cardiac arrhythmias, has partnered with advocacy organization StopAfib.org to encourage Americans to Get SMART About AfibSM. The initiative sets out to raise awareness of atrial fibrillation, or Afib, and available treatment options to better support the estimated three million people in the U.S. who are living with the condition. People can study up on Afib through an interactive website experience by logging on to www.GetSMARTAboutAfib.com.1

During Afib, an irregularity in the heart’s electrical system prevents the heart from beating normally and instead, the upper chambers of the heart (atria) quiver. This abnormal beating of the heart prevents the blood from effectively moving into the bottom chambers of the heart (ventricles), increasing the risk of stroke. In fact, Afib patients face a fivefold increase in their risk of stroke than those without the condition. Most patients are treated with medical therapy as a first line treatment to manage their Afib but over half of patients do not respond to, or can’t tolerate the side effects associated with, these medications.

“Over the past several years, there have been significant advances made in minimally invasive therapies for the treatment of atrial fibrillation, called catheter ablation, as well as stronger recommendations for use of this procedure in updated clinical guidelines published by the American Heart Association and the American College of Cardiology,” said Larry A. Chinitz, M.D., NYU Langone Medical Center. “Most recently contact force therapy has emerged as a very important advancement in the treatment of Afib as it has demonstrated significantly improved outcomes for patients with this condition.”

Earlier this year, the U.S. Food and Drug Administration approved the THERMOCOOL(R) SMARTTOUCH(R) Catheter, the first contact force therapy available in the U.S. The unique elements of this device help physicians deliver targeted treatment with precision and accuracy, ensuring a very high patient success rate as demonstrated in the SMART-AF Trial that studied the device.2 One-year results from the trial, which were recently published in the Journal of the American College of Cardiology, showed patients experienced an overall success rate of 74% and more significantly, an 81% success rate when consistent and stable application of contact force was achieved (when a targeted range was maintained >=80% of the time).3 The trial demonstrated for the first time that the use of contact force therapy helps to significantly improve outcomes for patients undergoing catheter ablation.

The Get SMART About AfibSM Initiative is a collaboration between Biosense Webster and StopAfib.org, which was founded by Afib patient Mellanie True Hills. Mellanie has devoted her life to raising disease awareness around Afib and available treatment options on behalf of patients like herself.

“Like many patients, medicines were not sufficient for managing my Afib. That’s why I worked closely with my doctor to find a procedure that was right for me, and I’ve been Afib-free for more than nine years,” said Mellanie True Hills, founder and CEO, American Foundation for Women’s Health and StopAfib.org. “Because of my experience, I work as an advocate for those who are living with Afib to help them better understand the condition and the importance of finding the right treatment options.”

As part of the Get SMART About AfibSM Initiative, people can visit the website to learn more about Afib, view dynamic videos and read stories about people who have had their Afib successfully treated.

“As a leader in the space, we have a strong legacy of developing innovations to address unmet needs in the treatment of heart rhythm disorders,” said David Shepherd, Worldwide President of Biosense Webster. “In recognition of Atrial Fibrillation Awareness Month, the Get SMART About AfibSM Initiative demonstrates our ongoing commitment to this important community so that in partnership with their physician, patients and their loved ones feel empowered to make the right choice about the therapeutic option they choose.”

About Atrial Fibrillation and Contact Force Therapy

Atrial fibrillation, or Afib, is the most prevalent heart rhythm disorder and is a leading cause of stroke among people 65 years and older. An estimated three million people in the U.S. and 20 million worldwide are affected by Afib, and its prevalence is expected to increase significantly as the population ages.4 Afib is a progressive disease and increases in severity and frequency as patients get older. 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 for the first time, 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

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. 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.

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

3. 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.

4. 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.

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