St. Jude nets FDA approval for low-radiation ablation catheters

St. Jude's MediGuide platform reduces radiation during ablation with the newly approved catheters.--Courtesy of St. Jude

St. Jude Medical ($STJ) won FDA approval for its line of three-dimensionally visualized ablation catheters designed to treat irregular heartbeats with reduced radiation, and doctors have performed the first procedure using the device.

The MediGuide Enabled Ablation Catheters, including the Safire Duo and Cool Path Duo, treat atrial flutter--a heart disorder that causes the upper chambers to beat faster than the lower chambers--by creating small lesions in the heart tissue, according to the company.

And with St. Jude's MediGuide navigation system, the catheters come equipped with 3-D magnetic tracking, which allows for visualization in real-time as the catheter is steered in the blood vessels and heart. Along with high-performance tips and uni-direction or bi-directional deflection, which gives them improved reach and control, both the Safire and Cool Path have 12 irrigation ports designed to cool the tissue at the site of ablation.

St. Jude touts the MediGuide technology as the first and only available system meant to reduce radiation exposure during ablation. This is a benefit to both patients and doctors. The American Heart Association found that, between 1980 and 2006, the amount of ionizing radiation patients received during medical tests increased by about 600%, and doctors are exposed to radiation on a regular basis as they perform the procedures.

"The new MediGuide Enabled Ablation Catheters expand the utility of the MediGuide System, which is an important platform that provides clinicians with the ability to reduce the duration of radiation exposure and consistency of procedures," Frank Callaghan, St. Jude's Cardiovascular and Ablation Technologies president, said in a statement. "The MediGuide technology is an example of our commitment to providing solutions for expensive and epidemic diseases that can have a direct impact on both physicians and patients."

And St. Jude could use a win in the cardiovascular arena, with those sales remaining flat year-over-year in the 2013 second quarter and net sales also stagnant so far.

- here's the release

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