Surgical Ablation Products Cleared for Market
A new, next generation high intensity focused ultrasound (HIFU) tool from St. Jude Medical were cleared for marketing by the Food and Drug Administration. The new Epicor LP Cardiac Ablation System is indicated to treat patients who have abnormal electric cardiac impulses as in atrial fibrillation.
One of the main differences between the Epicor and earlier generations of HIFU ablation systems is that the new device has a lower profile. Additional features incorporated are intended to support introduction of the device, as well as placement both on and around the patient’s heart. One benefit of the Epicor system is that it can be used with either a noninvasive or open chest approach.
The Epicor system was initially developed by Epicor Medical. The company was then acquired, in 2004, by St. Jude. Since that time, St. Jude has been collaborating with clinicians to further develop and refine the ablation tool.
Atrial fibrillation is one of the most common cardiac conditions across the United States. When this condition is not treated, patients have a five-fold risk of developing a stroke. A number of studies have validated the utility of HIFU as an appropriate means to treat inappropriate pulsing of the heart.
August 19, 2008 Related topics: Product Approval & Certification, Cardiology