PROVEN RESULTS BACKED BY 36-MONTH DATA
I PATENCY PR84% IMARY n the VERNACULAR Trial
ZERO FRACTURES
STENT In the VERNACULAR Trial ZERO MIGRATIONS In the VERNACULAR Trial STENT
1
1 The Venovo™
effectiveness endpoint of the study was primary patency (PP) at 12 months post-index procedure, defined as: freedom from TVR and freedom from thrombus occlusion and stenosis > 50% as measured by DUS. Patients who received a Venovo™
(PG) of 74%. At 36 months, patients who received the Venovo™
Venous Stent System was studied in the global VERNACULAR clinical trial, which was a prospective, multi-center, non-randomized, single-arm study of 170 patients. The primary Venous Stent had a weighted PP rate of 88.6%, demonstrating a statistically significant difference from a literature-derived performance goal
Venous Stent had an unweighted PP of 79.5% (84.0% K-M) (N=141). The primary safety endpoint was freedom from major adverse
events (MAE), including stent migration, through 30 days post-index procedure. Freedom from MAE was 93.5%, demonstrating a statistically significant difference from a literature-derived PG of 89%. Stents were evaluated at the 36-month follow-up for fracture analysis. An anteroposterior and lateral x-ray for each evaluated stent were sent to an independent core lab for analysis. 98 subjects’ x-rays were analyzed and no stent fractures were reported. Missing x-ray analyses were recorded as protocol deviations. Dake, Michael D, et al. “Three-Year Results from the Venovo Venous Stent Study for the Treatment of Iliac and Femoral Vein Obstruction.” Cardiovasc Intervent Radiol, vol. 44, no. 12, Dec. 2021,
https://doi.org/10.1007/s00270-021-02975-2. Epub 2021 Sep 20.
The Venovo™ Venous Stent System is indicated for the treatment of symptomatic iliofemoral venous outflow obstruction. The Venovo™ Venous Stent System is contraindicated for use in patients with a
known hypersensitivity to nitinol (nickel-titanium) and tantalum and patients who cannot receive intraprocedural anti-coagulation therapy. The stent is not designed for repositioning or recapturing. Potential Adverse Events include, but are not limited to: Allergic/anaphylactic reaction · Death related/unrelated to procedure · Dissection · Embolization · Extravasation · Hematoma, puncture site ·Hypotension/hypertension · Incorrect positioning of the stent requiring further stenting or surgery · Intimal injury/dissection · Ischemia/infarction of tissue/organ · Malposition (failure to deliver the stent to the intended site) · Open surgical repair · Pulmonary embolism · Stent Fracture · Stent Migration · Venous occlusion/thrombosis/restenosis Please consult product labels and instructions for the use of indications, contraindications, hazards, warnings, and precautions. BD, the BD logo, and Venovo are property of Becton, Dickinson and Company or its affi liates. © 2022 BD. © 2022 Illustration by Mike Austin. All Rights Reserved. BD-70896
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