Positive results for first-in-man study with bioconvertible caval filter

Peter Gaines
Peter Gaines

Twelve patients who were available for follow-up had good results at one year with the bioconvertible Sentry inferior vena cava filter (Novate), data presented at CIRSE 2013 shows.

Peter A Gaines, Sheffield Vascular Institute, Northern General Hospital, Sheffield, UK, who presented the results of the study, said: “This first-in-man study provides evidence confirming that the Sentry filter can be successfully deployed as intended without complications, can provide protection from pulmonary embolism for 60 days, and can reduce known early- and late-stage complications associated with filters.”

Gaines told delegates that studies have frequently reported that retrievable inferior vena cava filters experience several complications including tilting, migration, fracture, and perforation. “It is also reported that temporary or retrievable filters are not removed in up to 70% patients.”

Novate’s Sentry IVC filter is a novel bioconvertible vena cava filter, which automatically converts from a filtering (conical) to a non-filtering (stent) configuration after a minimum of 60 days from implantation, and therefore does not require retrieval. It is intended to offer temporary protection from a pulmonary embolism for a period of time and then become incorporated into the vena cava wall.

The investigators enrolled 14 patients of whom 12 remained in the study through a 12-month follow-up. The operators achieved technical success in all patients (defined as deployment at intended site without tilting, migration, fracture, thrombosis, stenosis, damage, or significant complications at the access vein site).

“Filtering configuration at 60 days was confirmed in 12/12 subjects. Non-filtering configuration was confirmed by 180 days in 10/12 subjects,” Gaines noted.

The researchers achieved clinical success in all 12 patients (as defined as the absence of pulmonary embolism and inferior vena caval occlusion during the indicated protection period of 60 days). There was no pulmonary embolism or occlusion at any time point throughout the 12-month follow-up, Gaines reported.