Medtronic to Initiate Clinical Study of Drug-Filled Stent

March 14, 2015—Medtronic plc announced the preclinical outcomes of its drug-filled stent (DFS) at the 64^th annual scientific session of the American College of Cardiology (ACC). 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. Medtronic advised that based on these results, it will initiate a clinical trial in the coming months.

The first global DFS study will be conducted at multiple sites in geographies including Australia and Brazil. The clinical study will enroll 100 patients and will evaluate late lumen loss as measured by quantitative coronary angiography. Gregg W. Stone, MD, will serve as the global chairperson of the Global Clinical Program executive committee. The study coprincipal investigators are Prof. Stephen Worthley, MD, and Alexandre Abizaid, MD.

In Medtronic’s press release, Dr. Stone commented, “Second-generation DES technologies have shown better clinical outcomes compared to first generation DES in a broad spectrum of patient anatomies and subsets, however, controlled polymer-free drug elution has the potential to further optimize acute performance, improve near-term and long-term clinical outcomes, and potentially allow for a shorter DAPT duration.”

Dr. Stone is Director, Cardiovascular Research and Education for the Center for Interventional Vascular Therapy at Columbia University Medical Center/New York-Presbyterian Hospital in New York, New York. Prof. Worthley is from Royal Adelaide Hospital in Adelaide, Australia. Dr. Abizaid is from Instituto Dante Pazzanese de Cardiologia in São Paolo, Brazil.

According to Medtronic, the DFS is built on the platform of the Resolute Integrity DES with Medtronic’s Continuous Sinusoid Technology (which molds one single strand of wire into a sinusoidal wave enabling a continuous range of motion), as well as the next-generation Resolute Onyx DES with CoreWire Technology that allows it to have a denser core metal surrounded by a cobalt alloy outer layer.

The new DFS features a trilayer wire design, which allows the inner most core layer to be removed, so that the hollow strut lumen functions as an internal drug reservoir. The 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.

The company advised that the DFS is available for investigational use only and it is not approved for use outside of clinical studies. The Resolute Onyx DES received CE Mark in November 2014 and is an investigational device in the United States.