A Prospective, Multi-Center Study of the Bard® Denali™ Retrievable Inferior Vena Cava Filter System

Inclusion Criteria:

• The subject or their legally authorized representative demonstrates understanding ofthe nature of the study and voluntarily provides written informed consent prior to anydata collection or study procedures.

• The subject is ≥ 21 years old, must be either a male or non-pregnant female with anexpected lifespan sufficient to allow for completion of all study procedures. Anegative pregnancy test result (urine or blood) is required prior to implant. If anenrolled female becomes pregnant prior to study completion, participation in the studywill be terminated.

• Based on Investigator judgment, the subject is at increased risk of PE requiring venacaval interruption. Note: Subjects diagnosed with acute DVT and/or PE must haveobjective confirmation based on imaging evidence of at least one of those diagnoses.

• Patients without PE or venous thromboembolic disease (VTED) who are at risk of PE maybe enrolled in this trial. However, enrollment of these patients will be limited to amaximum of 40% of the total sample size.

• Based on Investigator's judgment, the subject has patent venous anatomy suitable forfemoral or jugular/subclavian access for filter placement (e.g. no excessivetortuosity).

• The IVC is ≤ 28 mm in diameter at the intended implantation site based on radiographicimaging evidence.

• Based on Investigator's judgment, the filter can be safely placed such that theposition of the filter tip is 1 cm below the lowest renal vein.

• Retrieval of the filter is expected within 180 days post placement. At the six monthfollow up, if the Investigator determines that the filter continues to be clinicallyindicated, the filter may be left in place until the risk of PE has passed or left inpermanently. All patients not having their filter retrieved at six months willcontinue be followed to 24 months or one month post filter retrieval, whichever comesfirst.

• The subject has patent venous anatomy suitable for jugular access for retrieval of thefilter based on imaging evidence within 48 hours prior to the filter placementprocedure. Imaging mode will be at physician's discretion.

• The subject is willing to comply with the protocol requirements and specifiedfollow-up evaluations.

Exclusion Criteria:

• The subject has a previously implanted filter in the IVC or superior vena cava (SVC).

• The subject has a duplicated or left-sided IVC.

• The subject has a severe spinal deformity that would impede access to the IVC for thefilter placement or filter retrieval procedures.

• The subject has a serum creatinine ≥ 2 mg/dl (and not on dialysis) within seven daysof study enrollment. Patients on dialysis are allowed to participate in this trial.

• The subject has a known uncorrectable bleeding diathesis or active coagulopathy.

• The subject has a life expectancy of < 25 months.

• The subject has a known allergy or sensitivity to nickel or titanium.

• The subject has a known allergy or sensitivity to iodinated contrast media, whichcannot be adequately pre-medicated. NOTE: Alternative contrast agents are notpermitted for the purposes of this study.

• The subject is currently participating in an investigational drug or another devicestudy.