According to reports yesterday by the Mumbai Bureau of Pharmabiz, and confirmed today by MassDevice, Medtronic has launched its Resolute Integrity Drug-Eluting Stent (DES) in India for the treatment of coronary artery disease (CAD). The Resolute Integrity is the only stent approved by the FDA for use in diabetics, based on a large cohort of diabetic patients in the Resolute clinical program.
Diabetics historically have had higher adverse events when treated with PCI (angioplasty and stents) — but the data from the Resolute trials showed virtually no difference between diabetics and non-diabetics, leading the FDA to approve the indication. Continue reading