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SIR 2026

Scientific Session

Venous Interventions

Session: Venous Interventions 1

Safety and Efficacy of the OATF® Optimal Inferior Vena Cava Filter: A First-in-man Single-center Prospective Study

Tuesday, April 14, 2026
3:27 PM - 3:36 PM ET
Location: 717
Purpose: IVC filters are dedicated to the prevention of pulmonary embolism (PE) when anticoagulation is contraindicated. The major drawback of filters is the tilt, as it compromises removal and reduces clot filtration capabilities. In this line, ALN designs a new self-centering filter, overcoming this tow flaw.

Materials and Methods: The objectives of this first-in-man open-label prospective single-center study (NCT05785676) were to evaluate the clinical safety and efficacy of the OATF® IVC filter. This was conducted on 50 consecutive patients requiring temporary or permanent IVC filtration. Clinical examination and thoracic and abdominal angio-CT scanner were performed at 6 months and one year if permanent indication or before removal.

Results: The filter was successfully implanted at the intended location in all the patients. During all the follow-ups, there was no clinical and scanographic evidence of PE recurrence. Only one case of major tilt ( >15°) was observed in a patient with major scoliosis, and > 3 mm filter strut IVC penetration occurred in 5 patients at the end of the follow-up. Neither migration nor fracture was observed. Retrieval was attempted in 25 (50%) patients after a mean period of 223 days (range: 20 -321 days) and was successful in all cases without additional maneuvers.

Conclusion: This prospective study confirms the relevance of the new design of the ALN OATF® retrievable IVC filter to prevent PE recurrence and facilitate filter removal when needed.