Author: Dr. Michael Lichtenberg

Institution: Vascular Center of Arnsberg, Germany

Summary

This presentation discusses the 12-month follow-up results of the BeYond Venous Stent System in patients with venous obstruction, focusing on its application in acute deep vein thrombosis (DVT), post-thrombotic syndrome (PTS), May-Thurner syndrome, and tumor-related venous obstruction. Real-world data from an international multicenter study showed that the BeYond Venous Stent System achieved a primary patency rate of 91.5% and demonstrated high clinical safety.

BeYond Venous PMCF Study

• Study Design: This study is a prospective, international, multicenter, single-arm post-market clinical follow-up (PMCF) study aimed at evaluating the safety and efficacy of the BeYond Venous Stent System. Seven centers participated, including Arnsberg, Aachen, Heidelberg, Zurich, Vienna, London, and Galway, enrolling a total of 112 patients.

• Study Objectives: The primary endpoint was the 12-month primary patency rate, with secondary endpoints including clinical outcomes and safety indicators. Follow-up intervals were set at 3 months, 6 months, 24 months, and 60 months.

Study Results

• 12-Month Primary Patency Rate: Among the 112 patients, the 12-month primary patency rate was 91.5%, and the technical success rate was 98.2%, indicating a high success rate in treating femoral and iliac vein obstructions.

• Secondary Patency Rate: The 12-month secondary patency rate was 93.2%, further confirming the long-term efficacy of the stent.

• Patient Scores: During the follow-up period, Villalta scores and Venous Clinical Severity Scores (VCSS) showed significant improvement. The average Villalta score dropped to 3.5 at 12 months, indicating substantial relief of clinical symptoms.

Clinical Significance

• Technical Advantages: The BeYond Venous Stent System is made from self-expanding nitinol, providing flexibility and strength to meet various anatomical needs. Its 10F low-profile design is suitable for vessels of different diameters and reduces the risk of procedural complications.

Conclusion

1. The BeYond Venous Stent System demonstrates excellent primary and secondary patency rates in patients with femoral and iliac vein obstructions, with long-term follow-up results showing significant improvements in patient quality of life.

2. The 12-month clinical follow-up data confirms the safety and efficacy of the BeYond Venous Stent System in treating acute DVT, PTS, and other venous obstruction conditions.

3. With future long-term follow-up data, the BeYond Venous Stent System has the potential to become a standard treatment option for venous obstruction.

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