Medtronic Stent Gets FDA Approval
Medtronic, Inc., has received approval from the U.S. Food and Drug Administration (FDA) for its Integrity Coronary Stent System, the Fridley-based medical device maker said Monday.
The new stent uses continuous sinusoid technology, which enables each stent to be made from a single wire-thus making it flexible and conformable to the natural shape of the patient's vessels. That's a departure from typical stents, which are made from rings of cobalt alloys.
“Clinicians clearly appreciate the superior deliverability of the Integrity stent,” Sean Salmon, vice president and general manager of Medtronic's coronary and peripheral division, said in a statement. “They are also intrigued at what else might be possible with continuous sinusoid technology.”
Dr. Mark Turco, director of cardiac and vascular research at Washington Adventist Hospital, was among the first cardiologists in the United States to use this stent in his practice.
“The Integrity stent system sets a new gold standard for deliverability thanks to the advance of continuous sinusoid technology,” he said in a statement. “This new platform negotiates the twists and turns of the coronary anatomy remarkably well. Credit goes to Medtronic for continuing to improve stent technology, as continuous sinusoid technology should prove to be an excellent platform for future product development.”
The Integrity Coronary Stent System received European regulatory approval in February and is currently available in about 100 countries outside of the United States.
Medtronic is Minnesota's ninth-largest public company based on revenue for the fiscal year that ended in April 2009, which totaled $14.6 billion. The company reported revenue of $15.82 billion in its most recently completed fiscal year.