CIRSE 22: The DEEPER LIMUS Trial: Temporary Spur Stent System for Below-the-Knee Disease
Published: 12 Sep 2022
CIRSE 2022 - Dr Marianne Brodmann (Medical University of Graz, AT) joins us in a short interview on the latest data from the DEEPER-LIMUS Trial, originally presented at the CIRSE Conference in 2022.
DEEPER LIMUS aims to evaluate the safety of ReFlow Medical's Temporary Spur Stent System in below-the-knee patients with peripheral arterial disease or critical limb ischemia. The Spur Stent System is designed for the treatment of long, diffuse and severely calcified infrapopliteal disease, and is currently only approved for investigational use.
Recorded Remotely from Graz, 2022.
Interviewer: Jordan Rance
Videography: Oliver Miles
"- My name is Marianne Brodmann. I'm from Graz, Austria. I'm a vascular specialist, angiologist as we call it here in Austria, and I'm the Substitute Head of the Division of Angiology here at the Medical University in Graz, Austria. And I'm very much interested... At our site we are a huge centre for endovascular therapy so that's my main focus.
Unmet Needs in BTK Disease
The unmet need in BTK disease, there are many unmet needs in BTK disease but the most... The most important unmet need is that we are able to create for the patient, the long term good outcome. And we still have the issue that we don't have the ideal vessel prep system to avoid recoil which is responsible for the restenosis and the recurrence of the disease below the knee. So this is the most important unmet need, to get the ideal vessel prep system for below the knee arteries.
The Spur Stent System
The Spur Stent system is a unique vessel prep system. It's a stent-based system and you have these spikes which are then going into the vessel wall and creating the... how to say? The holes, the tiny holes in the vessel wall which are responsible for the adequate vessel expansion. Then you can retract this a stent once again into a cover sheet and pull it out. So it's some kind of stent system which is therefore for a certain time. And this creates this really... How do you say? Focused force on the vessel that the expansion of the vessel wall is really done in the focused manner and that prevents recoil. This has been shown in the studies so far we have done with the Spur Stent system in different indications.
Study Design and Patient Population
The study design and patient population for the DEEPER LIMUS study which I'm going to present was CLI patients... CLI patients we treated with the Spur Stent system and we followed it with DCB, which was sirolimus, everolimus-coated coded DCB. It was a single centre study just, you know, to look at the primary efficacy after first... In combination with everolimus-coated DCB and it was below-the-knee disease with CLI.
The findings were really great. We are able to show that the vessel that there's really good six month primary endpoint right now, good patency, we can avoid recoil. And I think that's one of the most important things that we are really able to avoid recoil and therefore able to... Able to improve the longer term outcome. So these are the data so far.
The next steps will be that we compare the different kind of drug-coated technologies we have evaluated so far. And I guess then it's going into the field just to use the Spur Stent system as a vessel prep system especially in below the knee, it's really a very easy to handle device with no complications. We have sensed so far, and it's not only at our side but also the DEEPER-OUS and then the DEEPER study. So in... So in combination, there are more than 150 patients in this different trials where the efficacy safety.. and safety... efficacy and good safety profile of this device has been shown.