Trial results for retrievable filter

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Matt Johnson, Indiana University School of Medicine, USA, presented results of a clinical trial of the Option inferior vena cava filter (Angiotech) to the 34th Annual Scientific Meeting of the Society of Interventional Radiologists, held in San Diego, USA, March 2009.

The study set out to assess the safety and effectiveness of the device in terms of the protection it offers against pulmonary emboli as both a permanent and retrievable device.


According to Johnson, “The potential for retrieval increases the population in which inferior vena cava filters could be appropriately implanted.


“It also, arguably, improves the safety profile of the filters,” he added.


As well as being made of non-thrombogenic material, the manufacturers say that the Option filter offers unique filter apex and retention anchors, and is suitable for insertion through either the femoral or jugular route.


The multicentre, single-arm trial implanted the Option filter in a cohort of 100 patients at risk of pulmonary embolism in whom anticoagulation was either contraindicated or had failed. Thirty nine patients had filters removed within 175 days of implantation, and were then followed up for a period of 30 days. Other patients were considered to have permanent implants and were followed up to 180 days post implantation.


Five suspected cases of pulmonary embolism were reported in the study cohort, two cases of cabal thrombosis and four instances of filter tile of greater than 15 degrees. One case of recurrent pulmonary embolism and one of caval thrombosis were held to be related to the device. Of 15 deaths within the group, and 14 cases of deep vein thrombosis, none were found to be related to the filter.


The study reported an 88% clinical success rate, defined as successful filter placement without subsequent pulmonary embolism.

Thirty six patients had their filters successfully removed after a mean period of 67 days.


Johnson concluded that the Option filter offers a similar safety profile to other inferior vena cava filter devices.


This evidence will support the manufacturer’s application to the Food and Drug Administration in order to receive clearance to market and sell the Option vena cava filter in the USA.

 

 

Don’t miss Raman Uberoi, Oxford Radcliffe Hospital, UK, on the latest evidence around the use of inferior vena cava filters at the CX Venous Day (7 April 2009). Register Now!