A Medical Device Daily

Rex Medical (Conshohocken, Pennsylvania) reported implantation of its Option Retrievable Vena Cava Filter in an international clinical study.

Ten patients were implanted with the Option Filter for the prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE) using the Option Filter under the direction of Adrian Ebner, MD, chief of interventional procedures and cardiovascular surgery, French Hospital (Asuncion, Paraguay). The study protocol calls for up to 30 patients to receive an Option Filter.

Rex puts DVT as the leading cause of the more than 600,000 PE events annually and more than 100,000 deaths. PE occurs when blood clots become dislodged from the deep veins located in the legs and travel through the blood stream to the lungs. It has a mortality rate of more than 30%, if untreated.

Option is designed as a self-centering, low-profile vena cava filter and may be retrieved after the risk of PE has passed or left permanently in place. This design incorporates nitinol construction in a 6 Fr system for precise delivery, efficient clot capture, and resorption and device retrieval.

Ebner said “we were extremely pleased to have early institutional access to this unique and promising vena cava filter technology . . . . All 10 filters were deployed safely, accurately and without difficulty from both a femoral and jugular approach. We look forward to our continued participation in this exciting clinical study.”

A U.S. clinical study is planned to begin later this year to collect data to support the filter as a permanent and retrievable device. Preclinical data gathered in support of the clinical studies demonstrated excellent filter performance, including effective self-centering, complete clot resorption at 90 days and no migration or adverse events associated with filter implantation and retrieval up to 90 days. All implanted filters were successfully retrieved.

Rex develops minimally invasive devices for the cardiovascular, venous access, endosurgery and oncology sectors.