Medtronic Inc. (NYSE:MDT) said Monday that the Food and Drug Administration has approved its next generation Integrity coronary stents.
The company, based in Fridley, Minnesota, also said Integrity, made from continuous sinusoid technology, eventually would lead to the development of breakthrough devices like polymer-free drug filled stents (DFS).
Doctors use stents to prop open a patient’s clogged arteries. The first bare metal stents eventually gave way to drug-eluting stents (DES), which delivered a drug to help prevent restenosis, the re-closing of vessel walls.
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Medtronic’s Driver bare metal and Endevour stents are made from rings of a cobalt alloy that are shaped into crowns and, to maximize flexibility, laser-fused where only certain points on the crowns meet.
Instead of rings, continuous sinusoid technology enables Integrity stents to be made from a single wire, comparable to a flexible spring. The new design improves doctors’ ability to deliver the device without compromising the stent’s strength and conformability to vessel walls.
Medtronic officials say Integrity is the first step to drug-filled stents. Today’s drug-eluting stents contain polymer coatings that can degrade, causing inflammation, poor healing and clotting.
Researchers are looking to replace polymers with bio-reabsorbable materials that can safely break down in the body.
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Using nanotechnology, scientists also are developing metal coatings with tiny holes that can better control the release of drugs into the arterial wall. The technology would allow cells to absorb higher concentrations of the drug over time, preventing restenosis and reducing the patient’s reliance on Plavix, a widely used anti-clotting drug.
“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, including the potential for a drug filled stent, which could obviate the need for a polymer to regulate drug elution by using holes on the surface of a hollow tube.”