- Hello. My name is Michael Lichtenberg from Arnsberg Vascular Centre. I'm interventional angiologist practicing in the arterial and venous field for many years now.


Outline of the BioMimics 3D Stent Used in This Study

So this is a very unique stent design. It's a helical stent, which promotes swirling flow. And we know that swirling flow suppresses re-stenosis meaning with this stent, we can definitely work against re-stenosis and therefore it was very interesting to evaluate this swirling flow BioMimics stent in a multicenter prospective registry to see about the efficacy and safety for the stent.

Rationale

So it was a typical all-comers open registry with a multicenter inclusion meaning we included patients with different disease. There was a very open inclusion criteria catalogue, nearly no exclusion criteria.


Patient Population and Study Design


So we included patients with claudication, critical limb ischemia within the SFA and popliteal segment. And the very interesting thing is that so many centres took part in this trial and included more than 500 patients in a very short time in this registry. So I can say that I'm very proud of this group of physicians who included in this trial. And I really would say thank you as the principal investigator to all these participating centres for this trial.

Key Findings

So we found that the BioMimics stent was highly efficient in patients with short and long SFA and popliteal lesions, including CTOs, meaning patients with complex total occlusions, patients with severe calcification. We found a very high efficiency of the stent even for these most challenging patient cohort.

Take-Home Messages

So one aspect I would like to mention here, we allowed the centres to combine the stent with drug coated balloon angioplasty technique. We found no difference between DCB yes or no in conjunction with the stent, meaning the stent itself was so highly efficient that you don't even need a drug coated balloon. So therefore the conclusion of this registry is that this is a very efficient stent for many indication in patients with claudication and critical limb ischemia.