In 2010, the FDA issued a safety communication on retrievable Inferior Vena Cava (IVC) filters, which are frequently used in patients at risk for pulmonary embolism when anticoagulant therapy cannot be used or is ineffective. Since 2005, the FDA has received hundreds of device adverse event reports involving these IVC filters (device migration, embolizations, perforation of the IVC, filter fracture). Some of these events led to adverse clinical outcomes in patients. These events may be related to a filter remaining in the body for long periods of time, beyond the time when the risk of pulmonary embolism has subsided.
In response, the Society for Vascular Surgery (SVS) and Society of Interventional Radiology (SIR) formed an IVC Filter Study Task Force. The Task Force met throughout 2011 and 2012. Representatives from FDA, AHRQ, CMS, NIH, and IVC filter manufacturers have participated in meetings. SVS is represented by Dr. David Gillespie, Dr. Rodney White, Dr. John Rectenwald, and Dr. Marc Passman.
Select members of the Task Force submitted to FDA a pre-IDE protocol, entitled “Predicting the Safety and Effectiveness of Inferior Vena Cava Filters (PRESERVE).”
The PRESERVE trial is a multi-center, prospective, open-label, non-randomized investigation of all commercially available IVC filters in the United States placed in subjects for the prevention of death from fatal or symptomatic PE. This study will enroll approximately 1,800 IVC filter subjects at up to 50 sites in the United States. All treated subjects will be evaluated at procedure, 3-months, 6-months (phone), 12-months, 18-months (phone), and 24-months post-procedure. All subjects in whom the IVC filter is removed will be followed for 3-months post-retrieval. Mandated follow-up imaging will be performed at 3 (plain film) 12 and 24 months (non-contrast abdominal CT). Clinical visits with physical exam will be performed at 3, 12, and 24 months.
FDA has communicated its support of the SVS/SIR-sponsored PRESERVE trial as an acceptable alternative to an FDA-mandated 522 Post Market Surveillance study. FDA leaders reviewed the current use of IVC filters, their vision for collaboration on the PRESERVE trial, and outlined incentives for manufacturers to support the study, including its potential for providing evidence to expand device indications. To date, five IVC filter manufacturers have committed to participate in the PRESERVE trial.
Anticipating an IDE submission in early 2013, Task Force members are reviewing comments from manufacturers and FDA, evaluating information on sample size, and modifying the PRESERVE protocol.