Medtronic to initiate clinical study of Drug-Filled Stent following successful preclinical results


Medtronic unveiled the preclinical outcomes of its novel Drug-Filled Stent at the 64th Annual Scientific Session of the American College of Cardiology (14–16 March, San Diego, USA). The preclinical data showed controlled and efficacious drug elution into the arterial wall without a polymer carrier, while reducing diameter stenosis and achieving complete stent coverage quickly without inflammation. Based on these results, Medtronic plans to initiate a clinical trial in the coming months.

The first global Drug-Filled Stent study will be conducted at multiple sites in geographies including Australia and Brazil. The clinical study will enrol 100 patients and will evaluate late lumen loss as measured by quantitative coronary angiography. Gregg W Stone, director, cardiovascular research and education, Center for Interventional Vascular Therapy, Columbia University Medical Center, New York-Presbyterian Hospital, USA, will serve as the global chairperson of the Global Clinical Program executive committee. The study co-principal investigators are Stephen Worthley of Royal Adelaide Hospital, Adelaide, Australia and Alexandre Abizaid of Instituto Dante Pazzanese de Cardiologia, São Paolo, Brazil.

“Second-generation drug-eluting stent technologies have shown better clinical outcomes compared to first generation technology in a broad spectrum of patient anatomies and subsets, however, controlled polymer-free drug elution has the potential to further optimise acute performance, improve near-term and long-term clinical outcomes and potentially allow for a shorter DAPT duration,” said Stone.

The Drug-Filled Stent is built on the proven platform of the Resolute Integrity drug-eluting stent with Continuous Sinusoid Technology (a Medtronic method of stent manufacturing that moulds one single strand of wire into a sinusoidal wave enabling a continuous range of motion), as well as the next-generation Resolute Onyx stent with CoreWire Technology that allows it to have a denser core metal surrounded by a cobalt alloy outer layer. The new Drug-Filled Stent features a novel tri-layer wire design, which allows the inner most core layer to be removed, so that the hollow strut lumen functions as an internal drug reservoir. Drug is eluted from the core upon implantation through abluminal side holes on the surface of the stent, which allows for controlled, polymer-free drug elution over a desired period of time directly into the arterial wall to potentially avoid chronic inflammation and adverse vascular responses.

“While investigating some of the latest innovations—including both bioabsorbable polymers and polymer-free technologies—we identified several potential drawbacks,” said Jason Weidman, vice president and general manager of the Medtronic coronary business. “The internally-loaded Drug-Filled Stent has been developed to control drug release in the absence of a polymer carrier and eliminate inflammation due to polymer degradation. It is encouraging to see that the preclinical data confirm the ability of the Stent to address these issues and we believe the clinical programme will support the position of the device as a premium product that brings meaningful advantages to clinicians and patients.”

The Drug-Filled Stent is available for investigational use only and it is not approved for use outside of clinical studies. The Resolute Onyx drug-eluting stent received CE mark in November 2014 and is an investigational device in the USA.