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FDA-Approved DES for CAD is First to Feature Diabetes Indication
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A drug-eluting stent has been approved by the FDA for the treatment of patients with CAD who also have diabetes, making it the first stent of its kind to feature the indication, according to a press release.
The DES (Resolute Integrity, Medtronic) utilizes continuous sinusoid technology, which enables each stent to be made from a single strand of wire, enhancing the device’s deliverability, the release stated.
The approval was based on the stent’s clinical performance in the RESOLUTE clinical program. Specifically, in the RESOLUTE US trial, which included 1,402 patients (34% with diabetes) across 128 US-based centers, researchers observed 1-year rates of target lesion failure of 4.7%, clinically driven target lesion revascularization of 2.8%, and definite/probable stent thrombosis of 0.1%. The DES was also shown to match the safety and effectiveness of the everolimus-eluting stent (Xience V, Abbott) in two separate large randomized controlled trials (RESOLUTE All Comers and TWENTE).
Perspective
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Salvatore J. Tirrito, MD
An FDA-approved stent with a diabetes indication sets out a clear course of action in what had been a very complex decision-making process. When examining a CAD patient with heart disease, some of our most difficult-to-treat cases, there have always been questions about the appropriate treatment decision for borderline cases — whether it be bypass or stenting. Their disease is so complicated that it makes it very hard to determine a clear treatment path. With Resolute Integrity’s diabetes indication, it makes the decision a lot easier and allows you to feel more confident in your decision-making, knowing that a stent has been validated by the FDA for this specific subset of patients.Perspective
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James H. Myer, MD
To use a baseball analogy, the Resolute Integrity DES — with its unprecedented deliverability, trackability, biocompatibility and industry low rates of TLR and late loss — is an easy triple. Throw in its FDA approval with the first diabetes indication, which is not only anywhere from 30% to 50% of the patient population in interventional cardiology, but also some of the hardest cases we see in our practice, and it’s an absolute home run. For all of these reasons, I anticipate it making a huge impact on our practice, benefiting both physicians and patients. I expect it will be the No.1 stent we will be utilizing in the next 6 to 12 months.Click Here to Manage Email Alerts