FDA Clears STJ MediGuide Catheters

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Medical devices major, St. Jude Medical (STJ) has won Food and Drug Administration (:FDA) approval for its latest MediGuide Enabled Ablation Catheters. The advanced device enhances the efficiency of the company’s MediGuide System used to treat irregular heartbeats. The first procedure with the new catheters was conducted at the Utah Valley Regional Medical Center in Provo, Utah.

Interventional Electrophysiology (:EP) procedures, including catheter ablations and Cardiac Resynchronization Therapy (CRT) procedures, expose operators, staff and patients to the significant risks of fluoroscopy. As per the American Heart Association, humans exposed to ionizing radiation during medical tests have increased by a whopping 600% between 1980 and 2006. Cardiovascular patients comprise about one-third of the numerous radiation-based imaging studies conducted by physicians across the globe annually.

It has been clinically proven that the pioneering MediGuide Enabled Ablation Catheters can effectively reduce exposure to radiation during EP procedures. St. Jude considers the MediGuide technology to be the most important growth driver for its Atrial Fibrillation (AF) products portfolio under its Cardiovascular and Ablation Technologies Division (:CATD). The company plans to initiate a limited launch of its MediGuide mapping system in 2013, with a full launch in 2014.

In the second quarter of 2013, revenues from AF climbed 9% (up 12% in constant currency) year over year to $237 million. The FDA clearance and the subsequent sale of the new products in the U.S. should further boost revenues of the AF franchise, which is expected in the range of $930–$960 million for 2013.

St. Jude has a Zacks Rank #3 (Hold). Other medical stocks such as Hanger (HGR) and Alere (ALR), with a Zacks Rank #1 (Strong Buy) along with Hospira (HSP), carrying a Zacks Rank #2 (Buy), are worth considering.
 

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