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LINC 2022: Update on DEEPER LIMUS With Prof Brodmann: Temporary Spur Stent System

Published: 14 Jun 2022

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In this short interview recorded at LINC 2022, Prof Marianne Brodmann (Medical University of Graz, AT) provides an update on the DEEPER LIMUS Trial (NCT04162418) which studied the safety and efficacy of Reflow Medical's Temporary Spur Stent System (ReFlow Medical, Inc). 

Discussion Points:
1. Unmet Needs in Patients with Infrapopliteal Arterial Disease
2. Temporary Spur Stent System
3. Study Design & Patient Population
4. Key Findings
5. Take-home Messages
6. Next Steps

Recorded on-site at LINC 2022, Leipzig.

Interviewer: Mirjam Boros
Editor: Jordan Rance
Videographer: Tom Green 

Transcript

- My name is Marianne Brodmann. I'm from Graz, Austria from the Medical University from the division of angiology. We have a big vascular division and we concentrate mainly in endovascular procedures. This our main part of science and, and exploration.

Unmet Needs

I think the most important unmet need for dealing with patients with infrapopliteal disease is that we still do not have the adequate vessel prep technology. So there is a lot of science ongoing with regard to this and there are a lot of presentations here and I was able to present about this spur stent to do an adequate vessel prep for below the knee disease.

Temporary Spur Stent System

The temporary spur stent is a self expanding stent with a six French compatibility and it creates channels into the vessel wall. And with regard to these channels, which are created by the spikes on the stent, you should get a better drug uptake. It's not only you should you will get a better drug uptake. And I think this is very important because we also need drugs for below the knee treatment, for the long term outcome. So I think this is really preparing the vessel in an adequate way for that. And the other effect we see is that we've just controlled modifying the vessel wall. We don't see the usual issues we see in infrapopliteal disease treatment like recoil or dissections. And this is also very, very important because we then do not need a mechanical thing to fix the mechanical issue.

Study Design and Patient Population

The study designed it's single-arm prospective study, it's around 30 patients with below the knee disease rutherford two to five. So patients with medication and critical emphysema, multi-vessel below the knee disease.

Key Findings

The key, the key results to date are that we really see that at six months we have a very good freedom from, from TLR. We use it in our single centre prospective study with a limus coated balloon as an adjunctive. So we have really good six month results so far from the patients we overlook. And I think this is very, very, very encouraging. And the other key result is that the acute vessel gain with regard to this is norm you get a really great acute vessel gain. You don't get dissections you don't get recoil, you don't get perforations So the safety profile is also very great.

Take-home Messages

If I need to summarise the take-home message on the spur stent system in general I would say it's an ideal vessel prep system creating controlled expansion of the vessel wall without any safety issues and therefore, no need for other mechanical sealing of this issues and therefore providing better drug uptake for whatever we want to need, use in the future as a drug in below the knee treatment.

Next Steps

The next steps will be to compare the data from the different studies we have there. We, we have a paclitaxel control study. We have deeper limus controlled study. See, maybe draw some conclusions out of that. And then we will go for the next steps maybe a drug coated, deeper spur stent.