St. Jude Medical Inc. has reached yet another important clinical landmark by registering the first implant of its Amplatzer Cardiac Plug (ACP) in a clinical trial. The ACP clinical study is intended to evaluate the effectiveness of the device for the prevention of left atrial appendage (LAA) stroke. The trial will enroll roughly 400 to 3,000 patients with atrial fibrillation (an uncontrolled rate of heartbeat) across 90 centers in the U.S. and Canada.
Atrial fibrillation (AF) is the most common heart disease in people above the age of 65 and up to 90% of the clots that form in patients with AF originate from the LAA. Approximately 2.7 million Americans suffer from AF, according to the American Heart Association. If left untreated, AF can lead to fatal consequences and is responsible for about 20% of all ischemic strokes.
The minimally-invasive self-expanding transcatheter ACP device from St. Jude’s cardiovascular product line is used to seal off the opening of the LAA in patients ailing from non-valvular AF. The device is CE marked and has been the market leader since its launch in 2008. The clinical trial should provide further evidence that the device is superior to traditional medical treatments and will help St. Jude to receive approval from the Food and Drug Administration (FDA) for launching the product in the U.S.
In Jan 2013, STJ had received CE Mark approval for its advanced Amulet cardiovascular device, which is a notch above the original ACP. It has been developed with suggestions from physicians, who have already used the ACP in Europe and can be used to treat a wider range of appendage anatomies. Following the success of the ACP, the Amulet device should further boost structural heart devices sales.
The medical technologies giant remains committed to develop innovative offerings in the field of stroke care as it has huge market opportunity in this area. As per the World Health Organization (WHO), strokes occur in approximately 15 million people across the globe every year, rendering it to be one of the leading causes of death and long-term disability.
St. Jude currently has a Zacks Rank #3 (Hold). Edwards Lifesciences Corp. (EW - Free Report) , which also manufactures transcatheter heart valves, currently carries a Zacks Rank #2 (Buy).
While we remain on the sidelines regarding St. Jude due to softness in the core Cardiac Rhythm Management (“CRM”) business, medical products companies such as CareFusion and Covidien , which carry a Zacks Rank #2 (Buy), appear impressive.