Breaking Barriers in Venous Occlusions: Early Insights into 35 Cases Performed with a Novel Mechanical Thrombectomy Device

Monday, March 31, 2025

3:09 PM – 3:18 PM CT

Location: Music City Center, 202 BC

Presenting Author(s)

Angelo G. Marino, DO

Associate Professor
Yale School of Medicine, United States

Author/Co-author(s)

RO

Ryan O'Kelley, DO

Neuro, Vascular and Interventional Physician
Memorial Health University Medical Center, Savannah, GA, United States
RR

Raja Ramaswamy, MD

Department Chair and Medical Director of Radiology
Community Health Network, Indianapolis, IN, United States
SA

Steven Abramowitz, MD, RPVI

Chairman of Vascular Surgery
MedStar Health, United States

Purpose: Deep vein thrombosis (DVT) is a common condition associated with a high rate of morbidity {1}. Insufficient treatment of DVT can lead to residual venous obstruction which can further progress to fibrotic venous occlusions that are challenging to treat. These occlusions can lead to recalcitrant wounds, which have been associated with limb amputation {2}. The VenaCore thrombectomy catheter (Inari Medical, Irvine, CA) was recently introduced as a minimally invasive device purposefully designed to engage, separate, and remove challenging venous occlusions in the peripheral vasculature. This study represents the first evaluation of the feasibility of VenaCore.

Materials and Methods: This multicenter, retrospective analysis assessed patients who underwent treatment with VenaCore from March to August 2024. Baseline and procedural data, including venous segment treated, percentage of thrombus removed, and patency, were evaluated. An exact binomial test was conducted to assess the change from baseline in patency category (no patency, moderate patency, full patency). Available follow-up data was also assessed.

Results: Of 35 patients, the mean age was 57.9 ± 13.0 years, 54% were male, and the median Clinical-Etiology-Anatomy-Pathophysiology (CEAP) classification was 3 [IQR 3-4]. The majority of cases were unilateral (76%), and 77% of cases had involvement of femoral veins or below. A total of 109 venous segments in 44 limbs were treated. The estimated mean thrombus age based on symptom duration was 130.6 ± 166.2 days. Based on venograms, the median thrombus removal was 70% [IQR 30%-90%]. Post-procedure, all patients achieved moderate or full patency (Table), with 86% of patients improving by ≥1 patency category (p< 0.0001). Of 50 venous segments with data available at latest follow up (median 2 [IQR 1-3.5] months), 82% maintained moderate or full patency. Follow-up data was available for 2 treated limbs classified as CEAP-6 at baseline, with both limbs demonstrating improvement to a CEAP-5 classification. Further data will be available for the presentation, as follow-up is ongoing.

Conclusion: Mechanical thrombectomy with the VenaCore catheter successfully debulked and removed challenging venous occlusions, reestablishing patency and increasing cephalad flow. Additional studies are needed to validate the safety and effectiveness of the study device.