DIAMOND BAR, Calif., Feb 06, 2009 (BUSINESS WIRE) -- Biosense Webster, Inc., a Johnson & Johnson company, today announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval to the NAVISTAR(R) THERMOCOOL(R) Catheter for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with compatible three-dimensional electroanatomic mapping systems. Atrial fibrillation, or AFib, is a highly prevalent heart rhythm disorder and one of the most common causes of stroke.
On November 20, 2008, the FDA's Circulatory System Devices Panel unanimously recommended approval of the NAVISTAR(R) THERMOCOOL(R) Catheter for AFib. The NAVISTAR(R) THERMOCOOL(R) Catheter is the first and only ablation catheter in the U.S. to be approved for the treatment of this disorder, which affects an estimated 10 million people worldwide.
"Today's announcement is a milestone for electrophysiologists, physicians who specialize in heart rhythm disorders, and their patients throughout the U.S.," said Marcia S. Yaross, Ph.D., Vice President, Clinical, Regulatory and Health Policy, Biosense Webster. "This landmark decision by the FDA recognizes the safety and effectiveness of NAVISTAR(R) THERMOCOOL(R) Catheter ablation for the treatment of paroxysmal AFib and gives the medical community another treatment option for many patients whose often debilitating symptoms are not effectively managed through medical therapy."
Conditions of approval include a post-marketing registry and a physician education program about use of the product.
The NAVISTAR(R) THERMOCOOL(R) Catheter is also approved in the U.S. for the treatment of Type 1 atrial flutter, and recurrent drug/device refractory sustained monomorphic ventricular tachycardia due to prior myocardial infarction (heart attack). Atrial flutter and ventricular tachycardia are two types of cardiac arrhythmia.
"Since it was founded, Biosense Webster has been a leading provider of innovative products for the treatment of heart rhythm disorders and continues to partner with electrophysiologists to help advance ablation options for the millions of patients with these conditions," said Shlomi Nachman, Worldwide President, Biosense Webster. "Today's approval continues our legacy of innovation."
Clinical Data that Supported FDA Approval
Today's approval is based on results from a multicenter study comparing catheter ablation to drug therapy for the treatment of AFib. In this randomized clinical trial, catheter ablation was shown to significantly outperform anti-arrhythmic drug (AAD) therapy for the treatment of drug refractory recurrent symptomatic paroxysmal AFib. These data were first presented in November 2008 at the American Heart Association's Annual Scientific Sessions.
Patients receiving cardiac ablation with the NAVISTAR(R) THERMOCOOL(R) Catheter were significantly more likely to be free of recurring AFib and experienced fewer serious adverse events than those receiving AAD therapy.
This clinical trial was a randomized, unblinded and controlled evaluation of symptomatic, paroxysmal AFib patients who were refractory to at least one AAD and had at least three episodes of AFib in the six months prior to randomization. A total of 167 patients were enrolled from 19 sites throughout the world and the primary effectiveness endpoint (chronic success) was freedom from documented symptomatic AFib recurrence following procedural endpoint confirmation and absent new AAD use or repeat ablation outside of protocol-defined criteria.
The probability of chronic success was 62.7% for patients receiving NAVISTAR(R) THERMOCOOL(R) Catheter ablation at end of the 9-month effectiveness evaluation period, which is significantly superior (p<0.0001) to the 17.2% probability for the group of patients treated with AAD. The NAVISTAR(R) THERMOCOOL(R) Catheter ablation group also demonstrated a dramatic reduction in symptomatic AFib recurrence compared with patients treated with AAD (75% vs 21%).
Additionally, the NAVISTAR(R) THERMOCOOL(R) Catheter ablation group demonstrated an excellent safety profile with no device-related serious adverse events such as death, heart attack, stroke, cerebrovascularaccident, heart block or atrial perforation within seven days post ablation. Importantly, there was no clinically significant pulmonary vein stenosis in patients receiving ablation, and the incidence of serious adverse events in the NAVISTAR(R) THERMOCOOL(R) Catheter group in the 90 days following initiation of therapy was observed to be approximately half that in the AAD group (35.1 vs. 18.4%, p = 0.0221).
Biosense Webster sponsored this trial.
Today's approval by the FDA also includes the EZ STEER(R) THERMOCOOL(R) Navigational Catheter, which is a bi-directional version of the catheter. These catheters are compatible with 3-D mapping systems which recognize the CARTO(R) System magnetic location sensors. These include the CARTO(R), CARTO(R) XP, and CARTO(R) 3 EP Navigation Systems.
About AFib and Current Treatments
AFib is the most prevalent arrhythmia, affecting between 2.3 to 5.6 million adults in the United States, and is a leading cause of stroke among people 65 years and older. Worldwide, it is estimated that 10 million people have AFib, yet fewer than 80,000 are treated through ablation. The public health implications of AFib are a growing concern because those with the condition are at an increased risk of morbidity and mortality as well as a reduced quality of life.
Most patients with AFib today are treated with AADs even though about half of them are refractory to these drugs. During cardiac ablation, a catheter is inserted into the heart and energy is delivered through the catheter to those areas of the heart muscle causing the abnormal heart rhythm. This energy "disconnects" the pathway of the abnormal rhythm.
Cardiac ablation is an important therapeutic tool in treating arrhythmias. It is the standard of care for 'simple' arrhythmias, like Wolff-Parkison-White Syndrome and atrioventricular nodal re-entry tachycardia (AVNRT). It is increasingly being used for more complex arrhythmias like ventricular tachycardia and atrial flutter.
In 2006, the leading medical societies including the American Heart Association, American College of Cardiology and the European Society of Cardiology recognized catheter ablation as second-line therapy for AFib.
About Biosense Webster, Inc.
Biosense Webster, Inc., a Johnson & Johnson company, pioneered electrophysiology diagnostic catheters more than 30 years ago and continues to lead the industry as an innovative provider of advanced diagnostic, therapeutic and mapping tools. As the leader in navigation systems and ablation therapy, Biosense Webster, Inc.'s technology includes the largest installed base of navigation systems worldwide in leading hospitals and teaching institutions. With proprietary products such as the CARTO(R) XP System, the CARTOSOUND(TM) Image Integration Software Module, the THERMOCOOL(R) Irrigated Tip Catheter and the LASSO(R) Circular Variable Mapping Catheter, the company is changing the way electrophysiologists diagnose and treat arrhythmias.
For more information about Biosense Webster and its products, please visit: www.biosensewebster.com.
SOURCE: Biosense Webster, Inc.
Biosense Webster, Inc.
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