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Medical Device Research

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Matthew S. Johnson, MD, FSIR, is a Professor in the Department of Radiology and Imaging Sciences at Indiana University School of Medicine and Director of Clinical Research in the department. He is currently involved in the PRESERVE clinical trial: Predicting the Safety and Effectiveness of Inferior Vena Cava (IVC) Filters.” IVC filters are used to prevent blood clots from causing a pulmonary embolism, which kills 100,000-180,000 per year.

Retrievable vena cava filters have been associated with more medical complications compared to traditionally used permanent vena cava filters. The FDA recommends that the filters be removed once the clot has resolved and the patient is no longer in danger. In 2010, an FDA medical alert stated that these retrievable filters could move or break. Currently, the FDA warning that physicians should evaluate the risks and benefits of filter removal on a patient-by-patient basis.

The PRESERVE trial is examining why retrievable IVC filters were placed and patient outcomes. The goal is to evaluate the safety and efficacy of six commercially available filters “in a real world setting.” Principal Investigators on this study are Matthew Johnson, MD, and David L. Gillepsie, MD, FACS, from Southcoast Health System (Fall River, MA). New England Research Institutes, Inc. (NERI) has been contracted to conduct the study.

“[This study is] helping guide medical care,” states Dr. Johnson. The PRESERVE trial is the first large scale, multi-specialty, prospective clinical study in the U.S. to examine the use of IVC filters and long-term follow-up treatment. This trial is sponsored by the nonprofit IVC Filter Study Group Foundation, a collaborative group founded by Society of Interventional Radiology and Society of Vascular Surgery.

The PRESERVE trial is a five-year study and will enroll approximately 1,800 patients at 60 centers across the U.S, with 300 patients enrolled per commercial filter. Patients will be evaluated at procedure and followed up post-procedure at six months, 12 months, 18 months and 24 months.

The views expressed in this content represent the perspective and opinions of the author and may or may not represent the position of Indiana University School of Medicine.

Diana Lazzell