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 of
the nature of the study and voluntarily provides written informed consent prior to
any data collection or study procedures.

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

- Based on Investigator judgment, the subject is at increased risk of PE requiring vena
caval interruption. Note: Subjects diagnosed with acute DVT and/or PE must have
objective 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 may
be enrolled in this trial. However, enrollment of these patients will be limited to a
maximum of 40% of the total sample size.

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

- The IVC is ≤ 28 mm in diameter at the intended implantation site based on
radiographic imaging evidence.

- Based on Investigator's judgment, the filter can be safely placed such that the
position 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 month
follow up, if the Investigator determines that the filter continues to be clinically
indicated, the filter may be left in place until the risk of PE has passed or left in
permanently. All patients not having their filter retrieved at six months will
continue be followed to 24 months or one month post filter retrieval, whichever comes
first.

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

- The subject is willing to comply with the protocol requirements and specified
follow-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 the
filter placement or filter retrieval procedures.

- The subject has a serum creatinine ≥ 2 mg/dl (and not on dialysis) within seven days
of 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, which
cannot be adequately pre-medicated. NOTE: Alternative contrast agents are not
permitted for the purposes of this study.

- The subject is currently participating in an investigational drug or another device
study.