St. Jude Medical Announces Approval and First Use of MediGuide Enabled Ablation Catheters
St. Jude Medical, Inc. (NYSE: STJ), a global medical device company, today announced U.S. Food and Drug Administration (FDA) approval and first use of MediGuide Enabled™ Ablation Catheters. The ablation catheters, which are used to treat specific irregular heartbeats, expand the innovative MediGuide platform for St. Jude Medical.
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.
“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.”
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. They also include 12 irrigation ports for cooling tissue during 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 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.
The St. Jude Medical MediGuide technology provides a pioneering solution to better manage fluoroscopy exposure during Electrophysiology procedures. MediGuide Technology provides a comprehensive platform and set of tools to address a broad array of clinical applications including catheter ablations and CRT implants.
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.
Similar to a global positioning system (GPS) that automobile drivers use to determine the location of their car on a map, 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.
About St. Jude Medical
St. Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. St. Jude Medical is headquartered in St. Paul, Minn. and has four major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. For more information, please visit sjm.com.
This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. Such forward-looking statements include the expectations, plans and prospects for the Company, including potential clinical successes, anticipated regulatory approvals and future product launches, and projected revenues, margins, earnings and market shares. The statements made by the Company are based upon management's current expectations and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include market conditions and other factors beyond the Company's control and the risk factors and other cautionary statements described in the Company's filings with the SEC, including those described in the Risk Factors and Cautionary Statements sections of the Company's Annual Report on Form 10-K for the fiscal year ended December 29, 2012 and Quarterly Report on Form 10-Q for the fiscal quarter ended June 29, 2013. The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.
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