|Medtronic Issues First PMA Module for IN.PACT Balloon; St. Jude Announces Approval and First Use of Ablation Catheters|
|By Staff and Wire Reports|
|Thursday, 15 August 2013 19:55|
Marking a major milestone in the advancement of new treatments for peripheral artery disease, Medtronic, Inc. (NYSE: MDT) announced the submission of its first pre-market approval (PMA) module to the U.S. Food and Drug Administration (FDA) for the IN.PACT Admiral drug-eluting balloon. Designed to treat atherosclerotic lesions in the superficial femoral artery (SFA), the novel angioplasty device remains investigational in the United States.
"Pending FDA approval, we remain on track to launch the IN.PACT Admiral drug-eluting balloon in the United States during the second half of calendar year 2015," said Tony Semedo, president of Medtronic's Endovascular Therapies business. "In the meantime, we will continue working with leading healthcare providers and researchers around the world to amass clinical and economic evidence to support the global adoption of this innovative medical technology as an important addition to the treatment options for peripheral artery disease in the lower extremities."
St. Jude Medical, Inc. (NYSE: STJ), a global medical device company, today announced U.S. 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.
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