RETRIEVE Data Presented for the Crux VCF System

March 26, 2012—Crux Biomedical, Inc. (Menlo Park, CA) announced that data from the RETRIEVE clinical study of the Crux inferior vena cava filter (VCF) system for the prevention of pulmonary embolism (PE) were presented by Principal Investigator Robert R. Mendes, MD, at the 2012 Society of Interventional Radiology (SIR) annual scientific meeting in San Francisco.

The pivotal RETRIEVE study was a prospective, single-arm, multinational assessment of the safety, performance, and efficacy of the Crux VCF system with bidirectional retrieval as both a retrievable and a permanent device. It included 125 patients at high risk for PE and was performed at 22 centers in the United States, Australia, New Zealand, and Belgium. 

Risk factors included history of PE (37%), history of deep vein thrombosis (DVT) (50%), and active DVT at baseline (58%). 

Dr. Mendes reported that the technical success rate of filter deployment was 98%. Filter retrieval success was also 98%. The average retrieval time was 7 minutes, with the femoral approach used for retrieval in 70% of cases. By the 6-month follow-up of the study, no embolizations, migrations, or fractures were observed.
 Three patients had nonfatal PE confirmed by either CT or perfusion lung scan, and 13 had new DVT. 

“The Crux device demonstrated an excellent safety profile,” commented Dr. Mendes. “The clinical study evaluation has demonstrated the Crux VCF system device can be used safely for the prevention of recurrent PE.”


Crux Biomedical founder Tom Fogarty, MD, spoke with Endovascular Today about the challenges faced in the current vena cava filter market and the potential he sees for the Crux VCF. In designing the filter, he sought a device that would prevent the ingrowth and ineffectiveness that can be caused by a filter tilting within the vessel, as well as a design that is very unlikely to penetrate or perforate the vessel wall. He further aimed for the ability of the device to be both deployed and retrieved from either a femoral or a jugular approach. 

The Crux VCF consists of a self-expanding nitinol frame that includes two opposing spiral elements that are connected with nitinol clamps. Its filter web is composed of expanded polytetrafluoroethylene, and five tissue anchors are attached to the spiral elements. 

Dr. Fogarty hopes for US Food and Drug Administration clearance of the Crux filter within the year. He pointed to recent initiatives by the FDA to expedite approval processes when appropriate, but also a rigorous study design that followed the SIR's reporting standards for retrievable IVC filter placement and patient follow-up. 

The device has received CE Mark approval for commercial use in the European Union and is being studied in the United States under an investigational device exemption.