Advanced Filter Design


• Engineered for Stability • Proven Retrievability • Innovative Design


97.6% 1


RETRIEVAL SUCCESS RATE AT 2 YEARS1


The Denali™ Vena Cava Filter was studied in the DENALI clinical trial, a prospective multicenter trial of 200 patients with temporary indications for caval filtration who underwent implantation of the Denali™ IVC Filter. All patients were followed for 2 years after placement or 30 days after filter retrieval. The primary endpoints were technical success of filter implantation in the intended location and clinical success of filter placement and retrieval. Technical success of filter placement was defined as sufficient mechanical interruption in the vena cava to prevent pulmonary embolism (PE), and clinical success of filter placement was a composite endpoint that included freedom from subsequent PE, filter migration, vena cava occlusion, filter- or procedure-related death, adverse events associated with filter placement, or failure of filter placement. Per protocol, and in line with SIR guidelines, clinical success was achieved if the lower bound of the 95% CI was > 80%. Technical success of filter retrieval was achieved if the filter was retrieved intact without immediate complications, and clinical success of filter retrieval was achieved if the filter was retrieved without complications requiring intervention. Filter placement was technically successful in 199 patients (99.5%). Filters were clinically successful in 190 patients (95%). The rate of PE was 3% (n = 6), with 5 patients having a small subsegmental PE and 1 having a lobar PE. New or worsening deep vein thrombosis (DVT) was noted in 26 patients (13%). Filter retrieval was attempted 125 times in 124 patients and was technically successful in 121 patients (97.6%). The mean filter dwell time at retrieval was 200.8 days. There were no instances of filter fracture, migration, or tilt greater than 15° at the time of filter retrieval or during follow-up. Asymptomatic IVC narrowing following filter retrieval occurred in one patient, who remained in stable condition and experienced no subsequent sequelae. Stavropoulos SW, Chen JX, Sing F, et al. Analysis of the final DENALI trial data: a prospective, multicenter study of the Denali inferior vena cava filter. J Vasc Interv Radiol. 2016;27:1531-1538. doi: 10.1016/j. jvir.2016.06.028


Indications for Use: The Denali™ Filter is indicated for use in the prevention of recurrent pulmonary embolism via placement in the vena cava in the following situations: · Pulmonary thromboembolism when anticoagulants are contraindicated · Failure of anticoagulant therapy for thromboembolic disease · Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced · Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated. The Denali™ Filter may be removed according to the instructions supplied in the Instructions for Use under the section labeled: “Optional Procedure for Filter Removal”. Contraindications for Use: The Denali™ Vena Cava Filter should not be implanted in: · Patients with an IVC diameter larger than 28 mm. · Pregnant patients when fluoroscopy may endanger the fetus. Risks and benefits should be assessed carefully. · Patients with risk of septic embolism. · Patients with uncontrolled sepsis. · Patients with known hypersensitivity to nickel-titanium alloys. The Denali™ Vena Cava Filter should not be retrieved if significant thrombus is in or near the filter. Possible complications include, but are not limited to, the following: Movement, migration or tilt of the filter; Filter fracture; Detachment of components; Perforation or other acute or chronic damage of the inferior vena cava (IVC) wall; Acute or recurrent PE; DVT; Caval thrombosis/occlusion; Back or abdominal pain; Organ injury; Stroke; and Pain.


BD, the BD Logo, and Denali are trademarks of Becton, Dickinson and Company or its affiliates. © 2024 BD. All Rights Reserved. © 2024 Illustration by Mike Austin. BD-126210


Page 1  |  Page 2  |  Page 3  |  Page 4  |  Page 5  |  Page 6  |  Page 7  |  Page 8  |  Page 9  |  Page 10  |  Page 11  |  Page 12  |  Page 13  |  Page 14  |  Page 15  |  Page 16  |  Page 17  |  Page 18  |  Page 19  |  Page 20  |  Page 21  |  Page 22  |  Page 23  |  Page 24  |  Page 25  |  Page 26  |  Page 27  |  Page 28  |  Page 29  |  Page 30  |  Page 31  |  Page 32  |  Page 33  |  Page 34  |  Page 35  |  Page 36  |  Page 37  |  Page 38  |  Page 39  |  Page 40