Early data from a small set of patients implanted with Medtronic‘s (NYSE:MDT) drug-filled stent, presented today at the annual Transcatheter Cardiovascular Therapeutics conference in San Francisco, showed that the device “achieved rapid and well-controlled stent coverage,” the company said today.
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.
Today Medtronic said results from 6 patients in its Revelution trial showed an average of 90% strut coverage at 1 month, with a 2% rate of malapposed struts and minimal thickening of the vascular wall. The trial is slated to enroll 100 patients and is designed to evaluate late lumen loss via quantitative coronary angiography.
“Through our collaboration with interventional cardiologists from around the world to advance our coronary portfolio together, we believe the drug-filled stent represents a significant breakthrough in stent design and engineering that helps address current and next-generation technology challenges,” coronary & renal denervation general manager Jason Weidman said in prepared remarks.
“The novel DFS truly represents an innovative stent platform with advanced stent manufacturing to optimize clinical performance without the need of a polymer,” added co-principal investigator Dr. Stephen Worthley of Australia’s Royal Adelaide Hospital. “These patients implanted with the DFS have shown very promising early outcomes of strut coverage and healing that indicate the new platform may provide many clinical benefits, including shorter DAPT duration, and we look forward to evaluating how well the stent continues to perform throughout the trial.”