Drug-Eluting Stent For Coronary Artery Disease Approved By FDA

Medtronic Inc's Resolute Integrity™ Drug-Eluting Stent for treating coronary artery disease has been approved by the FDA, after studies showed consistent clinical performance among a wide range of patients, including individuals with diabetes. Coronary artery disease is a common complication for patients with diabetes. Medtronic says that its Resolute DES (drug-eluting stent) has the same drug (zotarolimus) and polymer (BioLinx) combination as its Resolute Integrity DES. However, the Resolute Ingegrity is more flexible - as the coronary arteries of patients with diabetes are usually narrower than those of other patients, this is a great advantage.

Medtronic says this is the first stent of this kind that carries an indication for use with diabetes patients with coronary artery disease.

In a communiqué issued by Medtronic, Martin B. Leon, M.D., principal investigator (PI) of the RESOLUTE US clinical study, said:

"The Resolute Integrity DES offers several notable benefits, starting with outstanding the coronary vasculature to the narrowed arterial segment that requires treatment. Its approval by the FDA is based on the impressive performance of the Resolute DES in a wide variety of patients.

With the device's compelling combination of deliverability, efficacy and safety, not to mention that it is the first DES approved for patients with diabetes, the Resolute Integrity DES promises to gain rapid acceptance in cath labs nationwide."

Medtronic says the Resolute Integrity DES is a progression on its Integrity bare metal stent, thanks to a proprietary engineering techology called CST (continuous sinusoid technology). CST "encompasses one continuous, single strand of wire that is molded into a sinusoidal wave and then wrapped in a helical pattern and laser-fused at certain points, making each stent comparable to a flexible spring".

The global RESOLUTE clinical program - randomized controlled human trials were carried out in nearly 250 centers in 32 nations and involved over 5,100 participants who received a Resolute DES. 1,535 of them were diabetics, approximately one third of all patients, which is about the same percentage as that found in the US patient mix. 

RESOLUTE US - randomized controlled human trials were done in 128 clinical sites across the USA, and involved 1,402 participants. A one-year follow-up revealed a 4.7% rate of target lesion failure, which is low, clinically-driven TLR of 2.8% (target lesion revascularization), and def/prob ST of 0.1% (definite/probable stent thrombosis). These impressive results were achieved even though 34% of participants had diabetes.