The Society of Interventional Radiology, the Society for Vascular Surgery and 7 medical device companies are teaming up for the 1st large-scale study of inferior vena cava filters, 4 years after an FDA warning that the devices might dislodge or fracture.
Enrollment in the 2,100-patient study, Predicting the Safety & Effectiveness of Inferior Vena Cava Filters (Preserve), is slated to begin next spring, according to a press release. The medical societies said they jointly formed the non-profit IVC Filter Study Group Foundation to run the 5-year trial, with at least 300 patients enrolled for each of the 7 devices in the study.
Doctors place the device in the inferior vena cava, the main vein that brings blood back to the heart from the lower half of the body, to keep blood clots from traveling to the lungs and causing pulmonary embolisms. The implant treats patients with venous thromboembolism who have not responded to or cannot take anti-clotting medications.
In August 2010, the FDA recommended that physicians consider removing retrievable IVC filters after logging 921 reports of "adverse events" related to the devices. The federal watchdog agency warned that certain IVC filters could fracture, causing pieces of the device to travel through the bloodstream to other parts of the body.
"Patient safety is imperative, which is why interventional radiologists and vascular surgeons are working together collaboratively to respond to FDA’s concerns regarding filter safety and effectiveness," foundation president Dr. John Kaufman said in prepared remarks.
"The Preserve study will benefit patients by helping determine how well filters prevent pulmonary embolism and when retrievable filters should be removed," added foundation vice president Dr. Peter Lawrence.
The Preserve study is being funded by 7 companies that make IVC filters, according to the release:
- ALN Implants Chirurgicaux (ALN vena cava filters)
- Argon Medical Devices (Option Elite retrievable vena cava filter designed and manufactured by Rex Medical)
- B. Braun (VenaTech LP vena cava filter)
- C.R. Bard (NYSE:BCR) Peripheral Vascular (Denali vena cava filter)
- Cook Medical (Cook Günther Tulip vena cava filter)
- Cordis Corp. (Cordis OptEase retrievable vena cava filter, Cordis TrapEase vena cava filter)
- Volcano (NSDQ:VOLC) (Crux vena cava filter).