First-in-Human Study with Eight Patients Using an Absorbable Vena Cava Filter for the Prevention of Pulmonary...

Area of Science:

• Vascular Surgery
• Medical Devices
• Pulmonary Embolism Prevention

Background:

• Pulmonary embolism (PE) remains a significant risk for patients undergoing major surgery or with deep vein thrombosis (VTE).
• Transient inferior vena cava (IVC) filters offer a potential solution for temporary protection against PE.
• The development of absorbable IVC filters aims to eliminate the need for retrieval procedures.

Purpose of the Study:

• To evaluate the initial human safety and efficacy of a novel, absorbable vena cava filter.
• To assess the performance of a transient IVC filter in preventing pulmonary embolism in high-risk patients.

Main Methods:

• A prospective, single-arm, first-in-human study involving 8 patients at elevated risk for VTE.
• Placement of seven absorbable IVC filters (polydioxanone) before orthopedic and gynecologic surgeries, and one for deep vein thrombosis.
• Monitoring via CT cavography and radiography for filter migration, embolization, perforation, thrombosis, and stenosis at multiple time points.
• Pulmonary CT angiography used to assess for PE before and 5 weeks after filter placement.

Main Results:

• No symptomatic pulmonary embolism (PE) was reported or detected during the study period.
• Absence of filter migration, embolization, caval perforation, or caval stenosis confirmed by imaging.
• All implanted filters remained in their intended locations without adverse events.
• 100% clinical success rate observed in the study cohort.

Conclusions:

• The absorbable vena cava filter demonstrated excellent safety and efficacy in this initial human experience.
• The transient filter successfully prevented pulmonary embolism in all evaluated patients.
• High clinical success (100%) and technical success (89%) were achieved, with no filter-related adverse events.