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Safety and efficacy of the VenaTech™ Retrievable inferior vena cava filter: a first-in-man single-center prospective

Carole Déan¹, Young Il Kim¹, Olivier Sanchez²

¹Université de Paris-Cité, PARCC, INSERM-970, Department of Interventional Radiology Assistance Publique - Hôpitaux de Paris - Hôpital Européen Georges-Pompidou, 20 Rue Leblanc, F-75015, Paris, France.

CVIR Endovascular

|October 4, 2022

Insights

This study evaluated the Venatech® retrievable inferior vena cava (IVC) filter in 40 patients. The filter showed promising safety and efficacy, with successful placement and a high retrieval rate, indicating its clinical utility.

Area of Science:

Vascular Surgery
Interventional Radiology
Cardiovascular Medicine

Background:

Venous thromboembolism (VTE) is a global health concern with significant morbidity and mortality.
Inferior vena cava (IVC) filters are crucial for managing VTE in specific patient populations.
The Venatech® retrievable IVC filter's clinical performance requires thorough evaluation.

Purpose of the Study:

To assess the clinical safety and efficacy of the Venatech® retrievable IVC filter.
To evaluate the technical success rates of filter placement and retrieval.
To identify and analyze any complications associated with the IVC filter.

Main Methods:

An open-label, prospective, single-center study involving 40 patients.
Inclusion criteria: patients requiring temporary or permanent IVC filtration.
Assessment included patient characteristics, filter placement/removal success, complications, and follow-up CT scans.

Main Results:

100% technical success rate for filter implantation.
Successful retrieval in 85.7% of attempted cases (18 out of 21 patients).
No complications during placement or retrieval; observed issues included filter tilt and trapped thrombus, but no IVC thrombosis or filter fracture.

Conclusions:

The Venatech® retrievable IVC filter demonstrates encouraging preliminary safety and efficacy.
The filter is easily delivered and successfully removed in a high percentage of patients.
These findings support the Venatech® filter as a viable option for IVC filtration.

Read full analysis

Abstract

Background:

Venous thromboembolism (VTE) is a frequent condition worldwide, associated with significant morbidity and mortality. Though its primary treatment is anticoagulation, the placement of an inferior vena cava (IVC) filter is recommended in patients with some comorbidities. The objectives of this study were to evaluate the clinical safety and efficacy of the Venatech® retrievable IVC filter. This open-label prospective single-center study was conducted on 40 consecutive patients requiring temporary or permanent IVC filtration. Patient characteristics, technical success rates of filter placement and removal, and the occurrence of complications were assessed. Follow-up imaging was performed using CT-scan before retrieval or at 6 months in the permanent indication population.

Results:

The filter was successfully implanted at the intended location in all the patients. Retrieval was attempted in 21 (52.5%) patients after a mean period of 50 days (range: 6-94 days), and the filter was successfully removed in 18 patients (85.7%). Reason for retrieval failure was filter with trapped thrombus (n = 2) and a > 15° tilt (n = 1). No complication was observed during the filter placement and retrieval. Follow-up imaging available in 30 patients (75%) demonstrated deep filter penetration (> 3 mm) in four patients (13.3%), severe filter tilt (> 15^o) in five patients (16.7%), filter with trapped thrombus in three patients (10%), but no fracture or IVC thrombosis.

Conclusion:

This prospective study showed encouraging preliminary results of the safety and efficacy of the Venatech® retrievable IVC filter. The filter was easily delivered in the intended position and successfully removed in a high percentage of patients.

Trial Registration:

ClinicalTrials.gov Identifier: NCT02674672.

Keywords:

Deep vein thrombosis First-in-man Inferior vena cava filters Interventional imaging Prospective study Pulmonary embolism

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