Medtronic's Resolute Integrity DES Approved by FDA

February 17, 2012—Medtronic, Inc. (Minneapolis, MN) announced US Food and Drug Administration (FDA) approval of the Resolute Integrity drug-eluting stent (DES) for the treatment of coronary artery disease (CAD). The device was studied and approved in the United States for all patients with CAD, including those with diabetes.

Medtronic advised that the Resolute Integrity DES incorporates the company's continuous sinusoid technology, which encompasses a continuous, single strand of wire that is molded into a sinusoidal wave, wrapped in a helical pattern, and laser-fused at certain points, making each stent comparable to a flexible spring. The Resolute Integrity DES also features the company's MicroTrac delivery system.

The Resolute Integrity DES uses the same combination of the cytostatic, antiproliferative drug zotarolimus and the highly biocompatible BioLinx polymer, as used in the original Resolute DES, which has been available outside of the United States since 2007. The Resolute Integrity's CE Mark approval and market launch outside of the United States were announced in August 2010.
 

According to Medtronic, FDA approval of the Resolute Integrity DES is based on the results of a global series of studies that demonstrated the device's clinical performance across a broad spectrum of patients.


The global RESOLUTE clinical program consisted of one large randomized controlled trial and a series of confirmatory single-arm studies that comprised approximately 5,100 patients who received a Resolute DES at 250 sites in 32 countries. The program enrolled 1,535 (30.1%) CAD patients with diabetes, a proportion that mirrors the patient mix in the United States.



The RESOLUTE US trial was a clinical evaluation of the Resolute DES for treating de novo lesions in native coronary arteries. The trial enrolled 1,402 patients at 128 sites in the United States. In April 2011, Alan C. Yeung, MD, et al published the 1-year follow-up results in the Journal of the American College of Cardiology (2011;57:1778–1783).

The 1-year results included low rates of target lesion failure (TLF, 4.7%), clinically driven target lesion revascularization (TLR, 2.8%), and definite/probable stent thrombosis (0.1%). These results were achieved in a study population in which 34% of the patients had diabetes, which typically drives higher event rates. Low rates of TLF (6.6%), TLR (3.4%), and definite/probable stent thrombosis (0.3%) were also noted in a prespecified analysis of diabetic patients who received a Resolute DES as participants in the RESOLUTE clinical program.

Additionally, two large randomized controlled trials demonstrated that the safety and effectiveness of the Resolute DES matched the Xience V DES (Abbott Vascular, Santa Clara, CA).

The RESOLUTE All-Comers study enrolled approximately 2,300 patients at 17 centers. Patrick W. Serruys, MD, et al published the 1-year results in July 2010 in The New England Journal of Medicine (2010;363:136–146). In April 2011, Prof. Sigmund Silber, MD, et al published the 2-year results in The Lancet.

The TWENTE study, which was not part of the FDA dataset, enrolled approximately 1,400 patients at a single center, the Thoraxcentrum Twente in Enschede, the Netherlands. One-year results from TWENTE were presented in November 2011 at the Transcatheter Cardiovascular Therapeutics meeting in San Francisco. On February 15, 2012, Clemens von Birgelen, MD, et al published the results online ahead of print in the Journal of the American College of Cardiology. 

“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,” commented Martin B. Leon, MD, one of the RESOLUTE US Principal Investigators. “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.”