Cook IVC Filter Study

Cook IVC Filter Study

This prospective, multicenter, double-arm clinical study further evaluated the safety and effectiveness of Cook's commercially available inferior vena cava (IVC) filters (specifically, the Günther Tulip® Vena Cava Filter and Cook Celect® Vena Cava Filters) in patients in need of temporary or permanent IVC filter placement for the prevention of pulmonary embolism (PE).

Inclusion Criteria:

• Requires temporary or permanent IVC filter placement for the prevention of PE

Exclusion Criteria:

• Less than 18 years of age
• Known hypersensitivity or contraindication to contrast medium that cannot be adequately premedicated
• Known allergy or sensitivity to cobalt, chromium, or nickel
• Pregnant or planning to become pregnant in the next 12 months
• Patient refuses blood transfusions
• At risk of septic embolism
• Medical condition or disorder that would limit life expectancy to less than 12 months or that may cause noncompliance with the protocol or confound the data analysis
• Existing IVC filter
• Duplicate IVC
• Anatomy that would prevent safe filter placement (e.g., condition of access vessels)
• IVC diameter > 30 mm or < 15 mm