Biotronik I-Unipolar Pe-60 2-13

FDA-Cleared Indications

• Placement of an inferior vena cava filter for prevention of pulmonary embolism in patients at risk for pulmonary embolism.
• Use in patients with deep vein thrombosis or other conditions associated with venous thromboembolism when anticoagulation is contraindicated, ineffective, or insufficient, as specified by the applicable labeling.

Clinical Applications

• Percutaneous placement of an IVC filter in the inferior vena cava.
• Filter placement for patients with deep vein thrombosis who require protection from pulmonary embolism.
• Filter placement when anticoagulant treatment cannot be used or does not provide adequate protection.
• Use during an interventional radiology or vascular surgery procedure with imaging guidance to position the filter.

Reported off-label uses

• Use of an IVC filter for selected patients with recurrent pulmonary embolism despite therapeutic anticoagulation.
• Prophylactic IVC filter placement in selected patients considered to have very high pulmonary embolism risk without documented venous thromboembolism.

Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.

Practical Considerations

• The record identifies the device as an IVC-filter placement system and lists the PE-60 2-13 model designation; users should confirm the exact compatible filter, delivery system, and vessel-size requirements in the original manufacturer labeling.
• Placement requires imaging guidance, typically venography and fluoroscopy, with access commonly obtained through the internal jugular or common femoral vein.
• The device is from an older product generation. MRI safety and conditional-use information should be verified from the original labeling or manufacturer before MRI, rather than assumed from the device name.
• Potential procedural concerns include malposition, migration, vessel injury, bleeding at the access site, thrombosis, and perforation; patient selection and follow-up should follow current IVC-filter guidance.
• Contraindications and precautions include unsuitable IVC anatomy, active infection at the access site or along the procedure path, uncorrectable bleeding risk, and inability to safely access or visualize the IVC.