Medical Device Daily Staff Writer

Worldwide, physicians perform several billion radiation-based imaging studies annually, about one-third of which are in cardiovascular patients. According to the American Heart Association (Austin), the collective dose of ionizing radiation that patients annually received during medical tests increased among the general population an estimated 600% between 1980 and 2006. As a result, there has been a dramatic increase in human exposure to ionizing radiation.

St. Jude Medical (St. Paul, Minnesota) has developed a line of devices that could help in the reduction of exposure to ionizing radiation in cardiovascular patients. The firm reported FDA approval and first use of MediGuide Enabled Ablation Catheters. The ablation catheters, which are used to treat specific irregular heartbeats, expand the firm's MediGuide platform.

The MediGuide Enabled ablation catheters can be visualized using 3-D magnetic tracking. MediGuide technology is the first and only system to potentially reduce the duration of radiation exposure during catheter ablation procedures. The catheters are used to create lesions (tiny scars) 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. MediGuide sensors allow the catheters to be visualized and navigated in real-time on pre-recorded fluoroscopy.

"Approval of the new MediGuide Enabled Ablation Catheters now allows physicians to treat patients for atrial flutter while visualizing the catheters on the pre-recorded cine loop, which potentially reduces the durations of radiation exposure. As you may be aware, radiation exposure in the U.S. has doubled in the past two decades," told Medical Device Daily via e-mail.

The spokesperson added, "Similar to a GPS, the MediGuide Technology uses low power electromagnetic signals to locate a miniature sensor, which is placed in the tip of the catheter. The precise location and orientation of the catheter is tracked inside the heart and its image is then displayed on monitors in the EP lab. At the beginning of the procedure, a short duration of fluoroscopic images are taken and then replayed throughout the procedure. This allows physicians to see a real-time, 3-D representation of the catheter tip without exposing themselves, support staff and patients to additional radiation. The system also makes automatic adjustments to the recorded images throughout the procedure to maintain an accurate, real-time representation of the heart that compensates for respiratory changes, cardiac motion and patient movement. Prior to the approval of the ablation catheters, the MediGuide system was only able to be used for diagnostic procedures and CRT implants."

The company said that both the Safire Duo and Cool Path Duo irrigated tip ablation catheters can now be visualized and navigated in real-time on pre-recorded fluoroscopy with MediGuide Technology. Featuring a high-performance tip with uni-directional or bi-directional deflection, these ablation catheters have the ability to be steered in two different directions for improved reach and maneuverability. The two catheters also include 12 irrigation ports for cooling tissue during procedures.

"This flexibility promotes efficiency and was designed to provide electrophysiologists with increased control over their delivery of ablation therapy," a company spokesperson said. "What's different about the Safire Duo and Cool Path catheters are the handles. Designed to be ergonomically appealing and provide physician comfort for both routine and complex ablation procedures, physicians can choose between the ComfortGrip for the Safire Duo catheter or push/pull style handle for the Therapy Cool Path catheter."

St. Jude has already secured approval outside of the U.S. The company told MDD via e-mail that the MediGuide Ablation Catheters were CE mark approved in May 2012.

Originally, the MediGuide technology was bought by St. Jude Medical when the company acquired MediGuide in 2008 (Medical Device Daily, Dec. 23, 2008).

St. Jude acquired the company because MediGuide had developed a navigation system, the Medical Positioning System (gMPS), that uses technology for real-time tracking of sub-millimeter sized sensors.

"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 improve the accuracy and consistency of procedures. 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," said Frank Callaghan, president of the St. Jude Medical Cardiovascular and Ablation Technologies Division.

With the approval of this device, the company has a chance for a deeper penetration of the AF market, which is estimated to be more than $2.5 billion in revenue.

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