In short
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.
Background
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 Integrity is more flexible and as the coronary arteries of patients with diabetes are usually narrower than those of other patients, the company claims 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.
Clinician comments
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 deliverability, which means it’s exceptionally easy to navigate the stent on the delivery system through the coronary vasculature to the narrowed arterial segment that requires treatment,”
“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.”
What’s different with Resolute Integrity?
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”.
Resolute Clinical studies
The global RESOLUTE clinical program was a randomised controlled human trial, carried out in nearly 250 centers in 32 nations and involving 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.
In the RESOLUTE US randomized controlled human trials 1402 participants came from 128 clinical sites across the USA. A one-year follow-up revealed a 4.7% rate of target lesion failure, which is low, clinically-driven Target Lesion Revascularisation (TLR) of 2.8%, and definite/probable stent thrombosis (def/prob ST) of 0.1%. These impressive results were achieved even though 34% of participants had diabetes.
Company comments
“The new Resolute Integrity DES comes to U.S. cath labs with compelling clinical evidence and a highly differentiated stent platform,” said Sean Salmon, president of Medtronic’s coronary and renal denervation business. “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. We are excited to provide this important advanced technology to U.S. patients and practitioners.”
Source: Medtronic
published: February 20, 2012 in: Approval/Clearance, Cardio, Medtronic, Regulatory, USA