Biosense Webster Announces FDA Approval of the ThermoCool^® SF Catheter in the United States

Biosense Webster, Inc. announced the FDA approval of the new ThermoCool^® SF irrigated ablation catheter in the United States.

The ThermoCool^® SF NAV Catheter combines Biosense Webster’s latest irrigated ablation technology with the accurate visualization of the Carto^®3 3D Mapping & Ablation System. The catheter was launched in Europe in October 2010, and has received excellent feedback from electrophysiologists who have used the product.

The ThermoCool^® SF NAV Catheter is approved in the United States for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation when used with Carto^® Systems and Type 1 Atrial Flutter for patients 18 years and older.

Unlike competitive irrigated technologies, the innovative catheter design and breakthrough porous tip technology with Surround Flow technology of the ThermoCool^® SF Catheter allows for uniform cooling of the entire catheter tip, and efficient heat dissipation when ablating. This cutting-edge innovation provides more effective cooling and allows half the volume load to the patient, when compared to the traditional ThermoCool^® Catheter.

“We are proud to offer electrophysiologists in the United States our latest irrigated ablation technology to help treat patients with cardiac arrhythmias,” said Shlomi Nachman, Worldwide President, Biosense Webster.

About AF and Cardiac Ablation

Atrial fibrillation is the most prevalent arrhythmia, and is a leading cause of stroke among people 65 years and older. Worldwide, it is estimated that 20 million people have AF, yet only ~130,000 are treated with ablation every year. The public health implications of AF are a growing concern because those with AF are at an increased risk of morbidity and mortality as well as a reduced quality of life.

Most patients with AF today are treated with anti-arrhythmic drugs (AADs), even though about half of them are refractory to these drugs. During cardiac ablation, 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 commonly used for “simple” arrhythmias, like Wolff-Parkinson-White Syndrome and atrioventricular nodal re-entry tachycardia (AVNRT), and is increasingly being used for more complex arrhythmias like ventricular tachycardia and atrial fibrillation. ThermoCool^® Navigation Catheters are approved for drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with Carto^® Systems (excluding the NaviStar^® RMT ThermoCool^® Catheter).

Cameron Health Submits PMA Application to FDA for the S-ICD^® System

Cameron Health, Inc. announced that it has submitted the Premarket Approval (PMA) application to the Food and Drug Administration (FDA) for the S-ICD System, the world’s only completely subcutaneous implantable defibrillator.

“This is an important milestone for our company. We look forward to working closely with the FDA through the review process to make this important technology available to more patients at risk of sudden cardiac arrest,” said Kevin Hykes, Cameron Health’s President and CEO.