Irish medical technology firm Medtronic has unveiled plans to commence Drug-Filled Stent (DFS) trial at several sites in geographies including Australia and Brazil.
The firms’ decision was based on the preclinical results of the stent announced at the 64th Annual Scientific Session of the American College of Cardiology (ACC).
According to the company, the DFS demonstrated controlled and efficacious drug elution into the arterial wall without a polymer carrier, in addition to reducing diameter stenosis and achieving complete stent coverage without inflammation.
Medtronic coronary business vice president and general manager Jason Weidman said: "The internally-loaded DFS has been developed to control drug release in the absence of a polymer carrier and eliminate inflammation due to polymer degradation."
The company plans to enroll around 100 patients in the trial to assess late lumen loss as measured by quantitative coronary angiography.
Columbia University Medical Center’s Center for Interventional Vascular Therapy and New York-Presbyterian Hospital cardiovascular research and education director Gregg Stone will act as the global chairperson of the Global Clinical Program executive committee.
The study co-principal investigators will include Australia-based Royal Adelaide Hospital’s Stephen Worthley and Brazil-based Instituto Dante Pazzanese de Cardiologia’s Dr. Alexandre Abizaid.
Medtronic constructed the new DFS based on the platform of the Resolute Integrity DES with Continuous Sinusoid Technology and the Resolute Onyx DES with CoreWire Technology.
The new DFS features a tri-layer wire design that helps to remove the inner most core layer and drug is eluted from the core upon implantation through abluminal side holes on the surface of the stent, allowing polymer-free drug elution over a desired period of time.
The DFS, which is available for investigational use only, has not received approval for use outside of clinical studies.