The arrhythmia market is very large, exceeds $18-billion USD, and growing. Worldwide estimate: there are 10-million to 15-million in US (ACC Dec-05) and an additional 10-million to 20-million or more people outside US are afflicted with arrhythmia, and expanding. Annually, incidences of 720,000 (new cases) atrial arrhythmia are diagnosed. Atrial-fibrillation and Atrial-flutter are two most common forms of atrial arrhythmias.
The current treatment for atrial arrhythmia consists of medication, implantable devices, surgery and RF-catheter ablation. The latest data presented at the Heart Rhythm Society in Boston (May 20, 2006) indicates that ablation is 12 times more effective than anti-arrhythmic drugs (75%-ablation vs. 6%-drug) in clinical trials. The implantable devices have shown to have significant problems recently with device failures and disproportionate number of electrode lead infections that are accelerating. The surgery is an effective option piggy backed onto other primary procedures, but it is highly invasive and not preferred.
The company’s microwave endocardial ablation system has shown to be safe and effective in currently on going clinical trials abroad. The clinical and pre-clinical studies suggest the microwave energy can linearly ablate cardiac tissue without pain, pop, char and coagulum that are plaguing the RF ablation technology. The lack of pain is not only an important factor for the patient acceptance, but also a cost effective factor for the procedure since most of the procedures are done without general anesthetics outside of US.
Patient population is expanding and this market needs an ablation tool that can serve more than just 2% as RF has. The market is underserved and is in need of a technology that will make the curative treatment safer, effective and economical for more patients, physicians and hospitals. The microwave technology offers superior linear-curvilinear lesion ablation option to RF-current (conductive contact) point by point ablation.
The microwave technology overcomes many of the basic technology problems that are holding back the RF ablation systems from penetrating deeper into very large worldwide arrhythmia markets. The company’ proprietary microwave technology offers predictable precisely controlled ablation of cardiac tissues without collateral damage to adjacent organs.
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