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FDA approves Medtronic Integrity Coronary Stent

Medtronic, a provider cardiovascular devices, has received the US Food and Drug Administration (FDA) approval for its Integrity Coronary Stent system.

The Integrity bare-metal stent is based on sinusoid technology that enables the exploration of other device concepts such as a polymer-free drug-filled stent.

The Integrity Coronary Stent system coupled with the MicroTrac delivery system has been shown in bench testing and in blinded in vivo physician assessment studies to be highly deliverable, in traversing the patient’s vasculature and reach the narrowed heart artery targeted for treatment.

The Integrity stent is also made from cobalt alloy and is laser fused similar to Driver bare-metal and Endeavor drug-eluting stents and instead of rings, the continuous sinusoid technology enables each stent to be made from a single wire, comparable to a flexible spring.

Medtronic Coronary and Peripheral division vice president and general manager Sean Salmon said that clinicians clearly appreciate the superior deliverability of the Integrity stent.

“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,” Salmon said.