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Medtronic’s Resolute Integrity stent achieves US approval
Medtronic's Resolute Integrity drug-eluting stent has achieved a key regulatory milestone in the US after being approved for the treatment of coronary artery disease.
The US Food and Drug Administration (FDA) has ratified the device for this treatment specification after clinical trials showcased the advantages of its continuous sinusoid technology (CST).
Characteristic of the Resolute range, the CST design utilises a continuous strand of wire moulded into a sinusoidal wave and wrapped in a helical pattern and laser-fused, creating significant advantages in terms of flexibility and deliverability.
Evidence of the stent's benefits was collected during a global series of studies taking place at nearly 250 sites in 32 countries.
Sean Salmon, president of Medtronic's coronary and renal denervation business, said: "Our next-generation zotarolimus-eluting coronary stent has gained wide global acceptance for its remarkable ability to successfully meet clinical and anatomic challenges that interventional cardiologists confront in their everyday practice."
This comes after the firm announced data underlining the efficacy of its Complete SE vascular stent for treating atherosclerosis in the superficial femoral artery earlier this month.
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