Florida Hospital Leads in Visually Guided Catheter Ablation

Florida Hospital is the First Hospital in the Southeast to Perform Visually Guided Catheter Ablation for Irregular Heartbeats

ENdoscopic ABlation using Light Energy (ENABLE) Clinical Study Heats Abnormal Tissue to Treat Most Common Type of Arrhythmia

ORLANDO, Fla., Oct. 2, 2007 - Sixty-year-old Royice Rasnake has been suffering from periodic episodes of irregular heartbeat, dizziness, and fatigue for nearly six years.  Diagnosed with atrial fibrillation, an electrical disturbance of the heart caused by a "short circuit" involving the upper chambers of the heart, now Rasnake is one of the first patients in the Southeast to undergo a minimally invasive investigational procedure to treat the region of the heart that was causing this potentially dangerous arrhythmia.  Florida Hospital is one of just 20 hospitals in the United States to take part in the CardioFocus ENABLE Investigational Clinical Study which uses an endoscopically guided laser catheter to treat atrial fibrillation.

"For the first time we can see directly into the heart and treat the areas that are 'short circuiting' with more precision," said Dr. Scott Pollak, cardiologist, who along with Dr. George Monir is a principal investigator for the trial at Florida Hospital.  "We hope that this therapy will be an effective treatment for people with atrial fibrillation or heart rhythm disturbance."

During the procedure, a cardiologist inserts a slender catheter into a large vein in the patient's leg.  The catheter is threaded up into the right side of the patient's heart and guided into a larger vein in the left side of the heart using the investigational endoscopic video camera, small amounts of traditional real time X-ray, and ultrasound imaging.  Once in the area with the "short-circuiting" tissue, the cardiologist inflates the balloon and visualizes the target tissue.  After the target is located, the laser is turned on, which releases precisely controlled arcs of light around the vein.  The system is designed to use laser energy to destroy an area of abnormal tissue while causing no significant damage to surrounding healthy heart muscle.

ABOUT THE ENABLE STUDY

Clinical sites are currently recruiting patients to enroll in the CardioFocus ENABLE pivotal clinical study of the Endoscopic Ablation System (EAS)(www.cardiofocus.com/afib_trial_enable.htm).  This FDA-approved study is designed to assess the safety and efficacy of an investigational device for the treatment of paroxysmal atrial fibrillation (PAF).  As an investigational device, the EAS is only offered through this clinical study and is not commercially available.  The purpose of the study is to compare two types of treatment for PAF that are designed to treat the symptoms of atrial fibrillation.  The treatments being compared are:  Catheter ablation with the investigational EAS, a visually-guided, light-energy catheter and standard drug therapy (antiarrhythmic drugs).

ABOUT FLORIDA HOSPITAL

With seven hospitals and 16 Centra Care locations, Florida Hospital is one of the largest not-for-profit hospitals in the country, caring for more than one million patients each year.  The more than 1,900-bed hospital system has several major centers of excellence including Cardiology, Cancer, Neuroscience, Orthopaedics, and Diabetes.

 For more information, contact Florida Hospital Media Relations at 407-303-8217.

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