The device closes the vestigial structure attached to the upper chamber of the heart so that clots, which might otherwise break off and travel to the brain resulting in a stroke, can no longer emerge. There are approximately 2.2 million Americans diagnosed with AF and 200,000 new cases annually. The occurrence of AF is responsible for a five-fold increase in stroke incidence compared to patients with normal heart rhythm. Atrial fibrillation, a very common heart arrhythmia, causes a marked decrease in the pumping action of the upper chambers of the heart, which results in sluggish blood flow. When blood pools in the left atrial appendage, clots form that can, in time, break loose, or embolize, block arteries to the brain, and cause a stroke.
Clots can also block arteries to limbs or internal organs resulting in devastating consequences.
Blood thinners, however, present a risk of life-threatening hemorrhage and require major lifestyle changes. Frequent blood tests and dosage adjustments are needed to keep the blood anti-coagulated to the proper degree. Because of these issues, up to two-thirds of patients for whom the most common of such blood thinners, warfarin, is indicated are not given the medication or do not adhere to its regimen. While there are many new approaches for acutely treating stroke once it has occurred, ours represents the only means, in a single minimally invasive procedure, to actually prevent stroke in a high risk group of patients. Appriva has addressed one of the most significant problems in cardiac and cerebrovascular disease.