Esophageal Catheters

Electrophysiology (EP) Market: In this market, the Company's products, specifically the TAPCATH 205 and TAPSCOPE 210/210s catheters, address the noninvasive assessment of and treatment of cardiac arrhythmias, in particular the diseases of atrial fibrillation, atrial flutter, and other supraventricular tachyarrhythmias (SVT). There are an estimated 2-3 million people who suffer from these atrial rhythm diseases, and 300,000 new cases each year. These conditions are expected to grow as the population ages, since the diseases increase with age.

Stress Test Market: In the USA, approximately 6 million patients undergo a cardiac stress test each year, and this number is expected to increase significantly with the aging population. Stress tests are conducted either by exercising the patient or through non-exercise stress methods, primarily drugs.

TAPSTRESS is a direct competitor with the non-exercise tests done with heart rate accelerating drugs; TAPSTRESS accelerates the heart rate to the desired level by applying a small electrical stimulus to the left atrium through the esophagus. TAPSTRESS is also a potential substitute for traditional exercise ECG or exercise echo stress tests, because it is faster and supports continuous and clearer heart images, which provide for better diagnosis. In addition to its catheters, the Company sells the following equipment:

• The Model 7A Stimulator is designed specifically for transesophageal pacing. It sets up quickly and has easily adjusted dedicated controls. The user can regulate pacing intensity, pulse width and frequency for achieving capture of the patient's atrial activity and increasing heart rate as required. Indicated uses include: pacing-induced stress for diagnosis of ischemic heart disease; pacing stress during echocardiography and nuclear studies; stress testing of patients unable or unwilling to exercise; temporary acceleration of heart rate to overcome bradycardia in anesthetized patients.

• The Model 3 Preamplifier is the electronic link that connects a CardioCommand, Inc. disposable esophageal catheter and a standard ECG monitor. It eliminates noise artifacts due to respiration, swallowing and peristalsis, allowing noise-free esophageal recordings and accurate electrode positioning prior to cardiac pacing. It permits simultaneous recordings of esophageal ECG and surface Lead II making it possible for analysis of atrial activity. As a pacing interconnect device, the Model 3 transmits pacing pulses from the Model 7A Stimulator to the disposable esophageal catheter, either the TAPCATH 205 or the TAPSCOPE™ 210.