Thomas Zeller, MD, presented early findings of the DEEPER OUS trial, at the 2020 Virtual Amputation Prevention Symposium (AMP). Prof. Zeller is the head of the Department of Angiology at Universitäts—Herzzentrum Freiburg, Bad Krozingen, Germany, and Professor, and associate professor in the Angiology Division of the Universitaet-Herzzentrum Freiburg.
The DEEPER OUS trial is a multi-center, single-arm trial evaluating the safety and performance of the investigational device, in conjunction with a commercially available drug-coated balloon in patients with peripheral arterial disease, primarily critical limb ischemia (CLI).
Prof. Zeller notes that the safety of the novel Temporary Spur Stent System is reassuring, with “no acute complications,” and no issues with device delivery to the intended site.
He discusses the challenges of CLI and how the Temporary Spur Stent system addresses them. “Basically, the spikes are reaching the area which is of interest to deliver an antirestenotic drug,” by penetrating the adventitia. Preliminary results of the vessel recoil substudy are promising, he emphasizes, “we have a technology available that is reducing elastic recoil.”
The Spur System may be an alternative to stents, especially in segments that are hypermobile and averse to stent implantation, “to overcome the problem of elastic recoil, the Spur plays an important role.”
Watch the interview to hear his experience with the Temporary Spur Stent System as he discusses safety, vessel recoil, vessel patency, and future directions.