true
- Overview
- Products & Accessories
- Clincal Experience
- News & Media
- EIFU & Resources
Venous disease is complex, your stent choice doesn't have to be
false
Developed in collaboration with clinicians, the Venovo™ Venous Stent System is designed with a unique balance of radial strength, compression resistance and flexibility needed for the treatment of both post-thrombotic and non-thrombotic iliofemoral lesions. Additionally, the broadest size matrix available in the U.S.1 allows physicians to treat large diameter veins and long lesions.
Proven Long-Term Results Backed by 36-Month Data2
The VERNACULAR study results provide scientific evidence that the Venovo™ Venous Stent System is safe and effective for the treatment of symptomatic iliofemoral venous outflow obstruction.
The Venovo™ Venous Stent offers a broad selection of 42 sizing options in both 80 cm and 120 cm catheter lengths to accommodate a variety of iliofemoral lesions.
1 As of July 2022
2The 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 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™ Venous Stent had a weighted PP rate of 88.6%, demonstrating a statistically significant difference from a literature-derived performance goal (PG) of 74%, with an 81.7% PP rate for subjects with post-thrombotic syndrome and 97.1% PP rate for subjects with non-thrombotic iliac vein lesions. 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%. Primary Patency by Kaplan-Meier estimates at 36 months are 84.0% for the total population (N=170), 74.8% for subjects with post-thrombotic syndrome (N=93) and 95.5% for subjects with non-thrombotic iliac vein lesions. Secondary endpoints included acute technical success, Quality of Life (QoL) assessment, Venous Clinical Severity Score (VCSS – Pain score) and stent fractures. Results demonstrated 100% acute technical success, defined as successful deployment of stent(s) to intended target with adequate lesion coverage as assessed by the Investigator at the time of the index procedure. At the 36-month follow-up, the CIVIQ-20 assessment demonstrated a change from baseline in the total study population of -16.8 and, for the VCSS Pain score, a change from baseline in the total population of -1.8. 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
Please consult Instructions for Use for product indications for use, contraindications, warnings, precautions, potential complications, adverse events and detailed safety information.
BD - 23533v3
Please consult Instructions for Use for product indications for use, contraindications, warnings, precautions, potential complications, adverse events and detailed safety information.
BD - 23533v3
VERNACULAR Study Design
Prospective, multi-center, non-randomized, single-arm; Core lab & DSMB
Purpose
To assess the safety and effectiveness of the Venovo™ Venous Stent for the treatment of iliofemoral venous occlusive disease.
As Treated Population
170 subjects at 21 sites in the U.S., Europe, and Australia/NZ
Primary Endpoints*
- Primary patency (12 months)
- Freedom from MAE (30 Days)
Secondary Endpoints
- VCSS Pain Score/QoL assessment through 36 months
- Procedure/technical success at index procedure
- Freedom from TVR/TLR through 36 months
- X-ray analysis of stent fracture through 36 months
Primary Effectiveness
Weighted Primary Patency at 12-Months: 88.6%
- PTS: 81.7%
- NIVL: 97.1%
36-Month Results
(Kaplan-Meier estimated Primary Patency)
Primary Patency: 84.0%
- PTS: 74.8%
- NIVL: 95.5%
* Evaluated against literature derived performance goal of 74% for efficacy (p<.0001) and 89% for safety (p=.032)
1 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 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™ Venous Stent had a weighted PP rate of 88.6%, demonstrating a statistically significant difference from a literature-derived performance goal (PG) of 74%, with an 81.7% PP rate for subjects with post-thrombotic syndrome and 97.1% PP rate for subjects with non-thrombotic iliac vein lesions. 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%. Primary Patency by Kaplan-Meier estimates at 36 months are 84.0% for the total population (N=170), 74.8% for subjects with post-thrombotic syndrome (N=93) and 95.5% for subjects with non-thrombotic iliac vein lesions. Secondary endpoints included acute technical success, Quality of Life (QoL) assessment, Venous Clinical Severity Score (VCSS – Pain score) and stent fractures. Results demonstrated 100% acute technical success, defined as successful deployment of stent(s) to intended target with adequate lesion coverage as assessed by the Investigator at the time of the index procedure. At the 36-month follow-up, the CIVIQ-20 assessment demonstrated a change from baseline in the total study population of -16.8 and, for the VCSS Pain score, a change from baseline in the total population of -1.8. 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
Please consult Instructions for Use for product indications for use, contraindications, warnings, precautions, potential complications, adverse events and detailed safety information.
BD - 23533v3
-
Dr. Michael Dake, Senior VP for Health Sciences at the University of Arizona and Principal Investigator in the Venovo™ Venous Stent VERNACULAR trial shares key findings from the 24-month clinical results including primary patency rates, target lesion revascularization (TLR) and fracture rates, patient quality of life, and more.
-
Dr. Gerard O'Sullivan, FSIR, FEBIR of Galway University Hospitals in Galway, Ireland and Dr. Steven Dubenec, MBBS, FRACS, Head of Vascular Surgery at the Royal Prince Alfred Hospital in Sydney, Australia discuss important features of the Venovo™ Venous Stent and their personal experiences using the product. Recorded at the London Charing Cross Symposium in 2019.
Please consult Instructions for Use for product indications for use, contraindications, warnings, precautions, potential complications, adverse events and detailed safety information.
BD - 23533v3
Literature
BD's collection of literature on industry and on our offerings gives you information you can use to continue striving for excellence.
Learn more
Training
BD offers training resources to help improve your clinical practices as part of our goal of advancing the world of health.
Learn more
Events
BD supports the healthcare industry with market-leading products and services that aim to improve care while lowering costs. We host and take part in events that excel in advancing the world of health™.
Learn more
Case Studies
BD promotes clinical excellence by providing various resources on best practices, clinical innovations and industry trends in healthcare.
Learn more
true
Please consult Instructions for Use for product indications for use, contraindications, warnings, precautions, potential complications, adverse events and detailed safety information.
BD - 23533v3
true