St. Jude Medical, Inc., has seen its MediGuide Enabled™ Ablation Catheters gain U.S. FDA approval. The company is touting reduction in radiation exposure for patients, MediGuide using a previously recorded fluoroscopic map of the target tissue.
Background
Worldwide, physicians perform several billion radiation-based imaging studies annually, approximately one-third of which are in cardiovascular patients. 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.
As the name suggests, MediGuide is all about improving delivery of ablative treatment to the heart, bringing 3D magnetic tracking to the discipline. By allowing the company’s Safire™ Duo and Cool Path™ Duo irrigated tip ablation catheters to be visualized and navigated in real-time on pre-recorded fluoroscopy, the technology potentially reduces the duration of radiation exposure during catheter ablation procedures. 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. They also include 12 irrigation ports for cooling tissue during procedures.
MediGuide Technology allows physicians to see the precise location and orientation of MediGuide-enabled devices inside the heart. Using magnetic tracking to locate miniature sensors embedded in devices, this technology applies 3-D 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.
Physician comments
“The availability of MediGuide ablation catheter tools allows us to effectively treat patients with ablation therapy using minimal exposure to radiation,” said Dr. Chun Hwang, Director Cardiac Electrophysiology, from 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 EP lab.”
Company comments
“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 J. Callaghan, president of the St. Jude Medical Cardiovascular and Ablation Technologies Division.
Source: St.Jude Medical, Inc., Business Wire
Image provided courtesy of St. Jude Medical, Inc.
published: August 19, 2013 in: Approval/Clearance, Cardio, St Jude