Medtronic announced new clinical data from one of the endpoints in the RevElution Trial for its novel, next-generation Drug-Filled Stent (DFS).
These new data showed rapid vessel healing without inflammation in Optical Coherence Tomography (OCT) data of the complete one-month follow-up patient cohort.
The results were unveiled at the 65th Annual Scientific Session of the American College of Cardiology (ACC) on the heels of completing enrollment in the 50-patient cohort of the RevElution Trial, which will be used to support CE (Conformité Européenne) Mark.
The DFS is an innovative, polymer-free stent design, which elutes the drug (sirolimus) from the inside of the stent through laser-drilled abluminal holes.
This allows for a controlled and sustained drug elution directly into the arterial wall, which may eliminate potential drawbacks experienced with bioabsorbable polymers and polymer-free technologies, such as inflammation due to polymer degradation and uncontrolled drug release in the absence of a polymer.
"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," said Ajay Kirtane, M.D., director, New York-Presbyterian Hospital/Columbia University Cardiac Catheterization Laboratories, associate professor of medicine at Columbia University and member of the RevElution Trial Steering Committee.
"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."
In the fully completed one-month cohort of patients (N=15) from the RevElution Trial, which evaluated healing with OCT imaging, the DFS showed an early healing profile with an average of nearly 90 percent full strut coverage (new cell growth over stent struts) and a low rate of malapposed struts (1.5 percent).
Importantly, the data also showed minimal neointimal hyperplasia (NIH) formation.
"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," said Jason Weidman, vice president and general manager of the Coronary and Renal Denervation business, which is part of the Cardiac and Vascular Group at Medtronic.
"This breakthrough technology is a great example of our commitment to innovation through collaboration with physicians to address real unmet needs."
The Drug-Filled Stent is available for investigational use only outside of the United States.