The DFS is built using the Fridley, Minn.-based medical device giant’s Resolute Integrity and Resolute Onyx stents, using its “continuous sinusoid” and CoreWire technologies. It’s made with a “tri-layer” wire design in which the innermost layer is removed, leaving an empty space that’s lined with the anti-restenosis drug sirolimus. The drug is delivered via laser-drilled holes on the outer surface of the stent, designed for sustained elution directly into the arterial wall over a set period of time.
Yesterday the company released 1-month results from the 100-patient Revelution trial for 15 patients evaluated using optical coherence tomography, showing an “early healing profile” with an average of 90% full strut coverage, a 1.5% rate of malapposed struts and minimal thickening of the vascular wall. Those results echo earlier results released last October at the annual Transcatheter Cardiovascular Therapeutics conference in San Francisco.
Medtronic also said that it closed enrollment in the 50-patient DFS arm of the study.
“These data indicate that the DFS has the potential to positively address issues associated with polymer-based stents to optimize care for a wide range of patient populations,” vice president Jason Weidman said in prepared remarks. “This breakthrough technology is a great example of our commitment to innovation through collaboration with physicians to address real unmet needs.”
“The unique attribute of DFS technology is that it allows for controlled elution of drug directly from within a next-generation stent, obviating the need for a polymer,” added Dr. Ajay Kirtane of the Columbia University Medical Center. “If the encouraging early data from the Revelution trial continue to show promise with longer-term follow-up, they will set the stage for further pivotal investigations of the DFS. Furthermore, the ability to potentially reduce the mandatory duration of dual antiplatelet therapy following DFS implantation is vitally important for patients and treating physicians.”