Medtronic: Resolute stent functions well in diabetes patients two years out

Medtronic ($MDT) continues apace with the heavy sale for its Resolute Integrity drug-eluting stent. In advance of a major conference presentation on Sunday, the Minnesota device giant says the stent has performed well in patients with and without diabetes as a treatment for coronary artery disease.

The company seems to be positioning the product as the drug-eluting stent that can do everything, so to speak. Earlier this month, Medtronic revealed it gained approval in Europe for 7 new indications for the product, upping its total CE mark approvals to 9. Overseas, the stent can now be used to treat everything from acute coronary syndromes to in-stent restenosis and diabetes mellitus.

Integrity also stands out in the U.S. as the only drug-eluting stent that's FDA approved to treat coronary artery disease in diabetic patients, who have a much higher risk of contracting CAD. They're also harder to treat, Medtronic explains, because their coronary arteries are smaller and their high blood sugar levels can complicate the stent procedures.

That reality gives Medtronic's new Resolute data some important context and potentially significant industry punch. The company said 30% of patients that took part in its RESOLUTE clinical study had diabetes (878 to be precise, versus 1,903 who did not have the disease). Medtronic promises the study will show patients with diabetes had consistently low rates of problems for up to two years, despite their higher risk of complications. The rate of death, repeat procedures or heart attacks following stents hit 9.6% for patients with diabetes, and 7.1% for those who did not have the disease.

Of course, the rate of post-stent complications is still higher in the diabetes population. But the number appears low enough it seems to make Integrity stent a viable, less invasive option compared with what CAD/diabetes patients more typically face: open heart surgery. Medtronic will disclose further details on Sunday at the American Association of Clinical Endocrinologists 21st Annual Scientific and Clinical Congress in Philadelphia, during the event's late-breaking clinical trials session.

- read the release

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