OEM News, Regulatory

St. Jude Medical Reports First Use of New Catheter-Guiding Technology

The technology is also touted to reduce radiation exposure.

Soon after St. Paul, Minn.-based medical device titan St. Jude Medical Inc. gained U.S. Food and Drug Administration approval for its Mediguide Enabled ablation catheters, the company also announced the device’s first use. The ablation catheters, which are used to treat specific irregular heartbeats, add to St. Jude’s existing Mediguide platform.

Mediguide technology is described by company officials as similar to a global positioning system (GPS), as it is designed to allow physicians to see the precise location and orientation of Mediguide-enabled devices inside the heart. The technology uses magnetic tracking to locate miniature sensors embedded in devices and applies 3-dimensional visualization to previously recorded fluoroscopic images in real-time. Automatic adjustments are made to the recorded images to maintain an accurate real-time clinical representation compensating for cardiac motion, respiratory changes and patient movements in order to minimize workflow delays.

According to St. Jude, Mediguide technology can potentially reduce the duration of radiation exposure during catheter ablation procedures. The catheters are used to create lesions during cardiac ablation procedures to treat atrial flutter, a heart rhythm disorder where the upper chambers of the heart beat too fast and out of sync with the lower chambers.

“The availability of Mediguide ablation catheter tools allows us to effectively treat patients with ablation therapy using minimal exposure to radiation,” said Chun Hwang, M.D., director of cardiac electrophysiology at Utah Valley Regional Medical Center in Provo, Utah, who performed the first procedure with the new ablation catheter. “We are exposed to radiation multiple times a day, which adds up quickly. Reducing the exposure time to radiation is a huge benefit for everyone in the [electrophysiology] lab.”

This new technology can be used with St. Jude’s Safire Duo and Cool Path Duo irrigated tip ablation catheters, allowing visualization and navigation of these catheters in real-time on pre-recorded fluoroscopy, according to St. Jude. These ablation catheters are designed to be steered in two different directions for improved reach and maneuverability via uni-directional or bi-directional deflection tips. They also include 12 irrigation ports for cooling tissue during procedures.

According to the American Heart Association, the collective dose of ionizing radiation that patients annually received during medical tests increased among the general population an estimated 600 percent between 1980 and 2006. As a result, there has been a dramatic increase in human exposure to ionizing radiation.

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