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LINC 2025: 5-Year Follow Up of Venovo Venous Stent

Published: 06 Feb 2025

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LINC 2025 - Five-year, follow-up findings of the Venovo venous stent for venous recanalization in obstructive iliofemoral vein lesions show good patency rates, supporting the VERNACULAR (NCT02655887; C. R. Bard) IDE trial findings. The follow-up study also found improvements in quality of life, venous claudication, pain, and swelling after venous recanalization.

Dr Michael Lichtenberg (Vascular Centre Clinic Arnsberg, Arnsberg, DE) joins us to discuss the follow-up findings of the single-arm, observational, post-market study investigating the efficacy, safety and quality of life after implantation of the Venovo venous stent in patients with May-Therner syndrome and post-thrombotic syndrome.

Interview Questions:
1. What is the reasoning behind the trial?
2. What was the study design and patient population?
3. What are the key outcomes?
4. What are your take-home messages?
5. What further study is needed in this area?

Recorded remotely from Arnsberg, 2025.

Editors: Yazmin Sadik, Jordan Rance
Videographers: David Ben-Harosh, Dan Brent

Support: This is an independent interview produced by Radcliffe Vascular.

Transcript

Hello, my name is Michael Lichtenberg from Arnsberg Vascular Centre. I'm the Director of the Vascular Centre here in Arnsberg.

What is the reasoning behind the trial?

It's very important for venous stents to show that venous recanalization beside patency analysis also helps the patient in terms of their quality of life. So we intended with this trial, the Venovo long-term trial, to analyze the quality of life of these patients after venous stent implantation with the Venovo stent and followed up these patients right now up to 96 months to analyse their quality of life.

What was the study design and patient population?

So this was a single-centre, observational, post-market study. So we included 79 patients in this trial with mainly May-Therner syndrome, so [illegible] patients as well as patients with post-thrombotic syndrome. So a very mixed cohort of patients analysing efficacy and safety of this Venovo stent and focusing on the quality of life after venous recanalization.

What are the key findings?

So first of all we could support the already presented VERNACULAR trial which was the official IDE trial for FDA approval and CE Mark approval, especially in terms of patency rates. We were on absolutely the same page for patency rates after three years, and now with 96 months, we see very similar data in terms of patency rates. So that means that this stent shows very good patency rates in patients with [illegible] syndromes and post thrombotic syndrome. This is important to have these data for the first time in this way of long-term analysis, I think is very important.

Secondly, we could show that these patients improved very well after venous recanalization, especially in terms of their quality of life, especially with venous claudication, pain ulceration as well as persistent swelling. And I think this is important and we hope that these data especially to convince the payers in our country, and hopefully also in other countries, to reimburse the venous recanalization procedures much better.

What are your take-home messages?

Venous recanalization is safe and efficient. It helps patients who are suffering from post-thrombotic syndrome or pelvis venous insufficiency syndrome. It helps them to improve the quality of life with venous claudication with persistent swelling. So I think this is important to show that after venous recanalization, these patients are improving and showing this improvement over a long-term follow up.

What further study is needed in this area?

So we definitely need multi-centre trials for this so that a lot of experienced centres and physicians can involve patients in such trials or commerce registries to really prove that these patients are improving after venous recanalization. We desperately need more data to convince healthcare systems for better reimbursement of venous recanalization. I think these kind of all-commerce registries can help us to get better reimbursement.

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