SIR, Society for Vascular Surgery partner on IVC filter study

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The Society of Interventional Radiology and Society for Vascular Surgery jointly will launch PRESERVE-the first large-scale, multispecialty prospective study to evaluate the use of inferior vena cava (IVC) filters and related follow-up treatment.

The study-along with the formation of the IVC Filter Study Group Foundation-are direct actions taken to address the August 2010 FDA medical alert detailing the possibility that retrievable IVC filters could move or break, potentially causing significant health risks for patients. SIR and SVS are in the process of determining a framework for the PRESERVE (PREdicting the Safety and Effectiveness of InferioR VEna Cava Filters) study, with the goal of obtaining a functional view of all filters placed in the United States.

"PRESERVE data will allow a systematic, functional view, representative of all filters placed in the United States, thus, all stakeholders-individuals, health care professionals, insurers and government regulators-will be armed with the knowledge they need on patient risk and, subsequently, quality improvement in filter placement, management and retrieval," said SIR President Marshall E. Hicks, M.D., FSIR.

"This is a paradigm-shifting initiative: interventional radiologists and vascular surgeons collaborating to launch a large-scale prospective study evaluating inferior vena cava filters reveals a lot about each specialty's focus-and that focus is on patients, first and foremost," noted SVS President Peter Gloviczki, M.D.

The five-year study will evaluate the overall safety and efficacy of filters placed by doctors and intends to enroll 1,800 patients at approximately 50 centers in the United States. Members of the IVC Filter Study Group Foundation collectively discussed ways to respond to the FDA's stated concerns. SIR and SVS are in the process of making a final decision for a contract research organization, completing protocol development and submitting the study for investigational device exemption (IDE) study with HIPAA (Health Insurance Portability and Accountability Act) compliance. Study directors are Matthew S. Johnson, M.D., FSIR, Indiana University School of Medicine, Indianapolis, Ind., and David L. Gillespie M.D., FACS, University of Rochester School of Medicine and Dentistry, Rochester, N.Y. Most filter manufacturers have agreed to participate in the study.

Source: Society of Interventional Radiology

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