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Venous Technology
BD is committed to staying at the forefront of developing cutting-edge venous technologies to address the unique challenges of the venous anatomy and disease states.
- Overview
- Resources & Education
Finally, the venous stent you need for the iliofemoral veins.
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 broad size matrix allows physicians to treat large diameter veins and long lesions.
Proven safe and effective at 24-months1
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 illiac and femoral veins have unique challenges that must be addressed to reduce venous hypertension due to occlusive disease.
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Large Caliber
Veins typically have greater diameters compared to their corresponding arteries.4
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Diffuse & Focal Lesions
Long-diffuse lesions tend to be associated with post-thrombotic syndrome (PTS) necessitating longer stent lengths, while non-thrombotic iliac vein lesions (NIVL) tend to be more focal. 5
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Post-thrombotic changes
The presence of long fibrotic lesions require venous stents to have high radial force. 4
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Extrinsic compression
The presence of external compressions, such as a tumor or May-Thurner Syndrome, require venous stents to have high compression resistance. 4
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Complex curvature
Venous stents require high flexibility to accommodate the anatomic course of veins during movement. 4
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.
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BD Receives U.S. FDA Approval for First Venous Stent to Treat Iliofemoral Venous Occlusive Disease -
VERNACULAR trial 12-month data show successful use of Venovo stent in obstructive lesions
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Learn more about the 24-month results of the Venovo Venous Stent VERNACULAR trial -
The new Venovo Venous Stent is changing clinical practice -
One-year data from venous stent registry “promising” 3
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A Deeper Dive into the Venovo™ Venous Stent System
Related Solutions
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- 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. Patients who received a VENOVO™ Venous Stent had a weighted PP rate of 88.3%, demonstrating a statistically significant difference from a literature-derived performance goal (PG) of 74%. At the 24-month follow-up (N=147), the PP rate was 83.2% with the 95.2% PP in NIVL subgroup and 73.4% PP in the PTS subgroup. The primary safety endpoint was freedom from major adverse events (MAE) through 30 days post-index procedure. Freedom from MAE was 93.5%, demonstrating a statistically significant difference from a literature-derived PG of 89% and 0% stent migration. Secondary endpoints included acute technical success 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. Stents were evaluated at the 24-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. 128 subjects’ x-rays were analyzed and no stent fractures were reported. Missing x-ray analyses were recorded as protocol deviations. VERNACULAR Clinical Study. Data on File. Bard Peripheral Vascular Inc., Tempe, AZ.
- Results shown in bench testing. Average foreshortening = 2.9% (values based on mathematical calculations). Data on file, Bard Peripheral Vascular Inc., Tempe, AZ. Bench tests may not be indicative of clinical performance. Different test methods may yield different results.
- Data from the Arnsberg Registry are observational as reported by Dr. Lichtenberg. This is an independent, single-center analysis completed independently without support from BD.
- Jalaie H, Schleimer K, Barbati ME, Gombert A, Grommes J et al. (2016) Interventional treatment of postthrombotic syndrome. Gefasschirurgie 21 (Suppl 2): 37-44.
- Lichtenberg M, de Graaf R, Erbel C (2018) Standards for recanalisation of chronic venous outflow obstructions. Vasa 47 (4): 259-266.
The Venovo™ Venous Stent System is indicated for the treatment of symptomatic iliofemoral venous outflow obstruction.
The Atlas™ Gold PTA Dilatation Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the peripheral vasculature, including the iliac arteries and iliac and femoral veins, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for post-dilatation of stents and stent franfts in the peripheral vasculature.
Please consult package insert for all indications, contraindications, hazards, warning, precautions, and information for use. © 2020 BD. BD, the BD logo, Atlas Gold, and Venovo™ are the property of Becton, Dickinson and Company.
Illustration by Mike Austin. Copyright © 2020.
Bard Peripheral Vascular, Inc. | www.bardpv.com | 1 800 321 4254 | 1625 W. 3rd Street Tempe, AZ 85281. BD-12870
Venovo™ Venous Stent System Safety and Risk Information
Indications
The Venovo™ Venous Stent System is indicated for the treatment of symptomatic iliofemoral venous outflow obstruction.
Contraindications
The Venovo™ Venous Stent System is contraindicated for use in patients with a known hypersensitivity to nitinol (nickel-titanium) and tantalum, who cannot receive intraprocedural anti-coagulation therapy, or who are judged to have a lesion that prevents complete inflation of a balloon dilatation catheter or proper placement of the stent or the stent delivery system.
Warnings
The Venovo™ Venous Stent System is supplied sterile and is intended for single use only. Do not resterilize and/or reuse the device. Reuse, resterilization, reprocessing and/or repackaging may create a risk to the patient or user, may lead to infection or compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury, illness, or death of the patient. Reusing this medical device bears the risk of cross-patient contamination as medical devices – particularly those with long and small lumina, joints, and/or crevices between components – are difficult or impossible to clean once body fluids or tissues with potential pyrogenic or microbial contamination have had contact with the medical device for an indeterminable period of time. The residue of biological material can promote the contamination of the device with pyrogens or microorganisms which may lead to infectious complications or death. Do not use in patients with total venous occlusion that cannot be dilated to allow passage of the guidewire. Do not use the device with contralateral access. Do not use if pouch is opened or damaged. Do not use the device after the “Use By” date specified on the label. Persons with allergic reactions to nitinol (nickel-titanium) alloy and/or tantalum may suffer an allergic response to this implant. Do not expose the delivery system to organic solvents, e.g., alcohol. The stent is not designed for repositioning or recapturing. Stenting across a major branch could cause difficulties during future diagnostic or therapeutic procedures. If a long lesion needs to be stented consider using the longest available stent rather than overlapping stents. If multiple stents are placed in an overlapping fashion, they should be of similar composition (i.e., nitinol). The long-term outcomes following repeat dilatation of endothelialized stents are unknown. The safety and effectiveness of this device for use in the arterial system have not been established.
Precautions
The device is intended for use by physicians who have received appropriate training. During system flushing, observe that saline exits at the catheter tip. The delivery system is not designed for use with power injection systems. Recrossing a partially or fully deployed stent with adjunct devices must be performed with caution. Prior to stent deployment, remove slack from the delivery system catheter outside the patient. If excessive force is felt during stent deployment, do not force the delivery system. Remove the delivery system and replace with a new unit. Store in a cool, dark, dry place. Do not attempt to break, damage, or disrupt the stent after placement.
Potential Complications and Adverse Events
Allergic/anaphylactic reaction; Amputation; Aneurysm; Arteriovenous fistula; Death related/unrelated to procedure; Dissection; Embolization; Extravasation; Fever; Hemorrhage/bleeding requiring a blood transfusion; Hematoma; Hypotension/hypertension; Incorrect positioning of the stent requiring further stenting or surgery; Intimal injury/dissection; Ischemia/infarction of tissue/organ; Local infection; Malposition (failure to deliver the stent to the intended site); Open surgical repair; Pain; Pulmonary embolism; Pseudoaneurysm; Renal failure; Respiratory arrest; Restenosis; Rupture; Septicemia/bacteremia; Stent Fracture; Stent Migration; Vasospasm; Venous occlusion/thrombosis/restenosis
Please consult package insert for more detailed safety information and instructions for use.
BD, the BD logo, Bard, and Venovo are trademarks of Becton, Dickinson and Company or its affiliates. © 2020 BD. All rights reserved. Bard Peripheral Vascular, Inc. | 1 800 321 4254 | www.bardpv.com | 1625 W. 3rd Street Tempe, AZ 85281 BD-19558
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Designed to provide the optimal balance between radial force, flexibility, and compression resistance.
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Large balloon diameters up to 26mm. Ultra non-compliant technology offers virtually no growth past stated diameter*
- 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. Patients who received a VENOVO™ Venous Stent had a weighted PP rate of 88.3%, demonstrating a statistically significant difference from a literature-derived performance goal (PG) of 74%. At the 24-month follow-up (N=147), the PP rate was 83.2% with the 95.2% PP in NIVL subgroup and 73.4% PP in the PTS subgroup. The primary safety endpoint was freedom from major adverse events (MAE) through 30 days post-index procedure. Freedom from MAE was 93.5%, demonstrating a statistically significant difference from a literature-derived PG of 89% and 0% stent migration. Secondary endpoints included acute technical success 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. Stents were evaluated at the 24-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. 128 subjects’ x-rays were analyzed and no stent fractures were reported. Missing x-ray analyses were recorded as protocol deviations. VERNACULAR Clinical Study. Data on File. Bard Peripheral Vascular Inc., Tempe, AZ.
- Results shown in bench testing. Average foreshortening = 2.9% (values based on mathematical calculations). Data on file, Bard Peripheral Vascular Inc., Tempe, AZ. Bench tests may not be indicative of clinical performance. Different test methods may yield different results.
- Data from the Arnsberg Registry are observational as reported by Dr. Lichtenberg. This is an independent, single-center analysis completed independently without support from BD.
- Jalaie H, Schleimer K, Barbati ME, Gombert A, Grommes J et al. (2016) Interventional treatment of postthrombotic syndrome. Gefasschirurgie 21 (Suppl 2): 37-44.
- Lichtenberg M, de Graaf R, Erbel C (2018) Standards for recanalisation of chronic venous outflow obstructions. Vasa 47 (4): 259-266.
The Venovo™ Venous Stent System is indicated for the treatment of symptomatic iliofemoral venous outflow obstruction.
The Atlas™ Gold PTA Dilatation Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the peripheral vasculature, including the iliac arteries and iliac and femoral veins, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for post-dilatation of stents and stent franfts in the peripheral vasculature.
Please consult package insert for all indications, contraindications, hazards, warning, precautions, and information for use. © 2020 BD. BD, the BD logo, Atlas Gold, and Venovo™ are the property of Becton, Dickinson and Company.
Illustration by Mike Austin. Copyright © 2020.
Bard Peripheral Vascular, Inc. | www.bardpv.com | 1 800 321 4254 | 1625 W. 3rd Street Tempe, AZ 85281. BD-12870
Explaining deep venous disease to patients can be difficult. BD has developed comprehensive patient education materials to help facilitate these conversations. Click the icons to view BD's various venous educational tools. To order these for your practice, access the link below.
Looking for additional venous education resources dedicated to healthcare professionals? Our venous guide will address common questions regarding diagnosis, treatment options and other technical considerations for venous disease treatment. To learn more, view the deep venous guide below.
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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.
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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.
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A post-thrombotic case presentation, courtesy of Dr. Rick de Graaf, MD, PhD, Interventional and Neurointerventional...
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A patient shares her story three years after receiving a Venovo™ Venous Stent.
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Watch the video highlighting Dr. Dubenec’s case with the Venovo™ Venous Stent.
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Watch the video highlighting Dr. Desai's non-thrombotic iliac vein lesion case with the Venovo™ Venous Stent.
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Watch the video highlighting Dr. Desai's post-thrombotic syndrome case with the Venovo™ Venous Stent.
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Watch the video highlighting Dr. Tiede's case with the Venovo™ Venous Stent.
- 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. Patients who received a VENOVO™ Venous Stent had a weighted PP rate of 88.3%, demonstrating a statistically significant difference from a literature-derived performance goal (PG) of 74%. At the 24-month follow-up (N=147), the PP rate was 83.2% with the 95.2% PP in NIVL subgroup and 73.4% PP in the PTS subgroup. The primary safety endpoint was freedom from major adverse events (MAE) through 30 days post-index procedure. Freedom from MAE was 93.5%, demonstrating a statistically significant difference from a literature-derived PG of 89% and 0% stent migration. Secondary endpoints included acute technical success 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. Stents were evaluated at the 24-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. 128 subjects’ x-rays were analyzed and no stent fractures were reported. Missing x-ray analyses were recorded as protocol deviations. VERNACULAR Clinical Study. Data on File. Bard Peripheral Vascular Inc., Tempe, AZ.
- Results shown in bench testing. Average foreshortening = 2.9% (values based on mathematical calculations). Data on file, Bard Peripheral Vascular Inc., Tempe, AZ. Bench tests may not be indicative of clinical performance. Different test methods may yield different results.
- Data from the Arnsberg Registry are observational as reported by Dr. Lichtenberg. This is an independent, single-center analysis completed independently without support from BD.
- Jalaie H, Schleimer K, Barbati ME, Gombert A, Grommes J et al. (2016) Interventional treatment of postthrombotic syndrome. Gefasschirurgie 21 (Suppl 2): 37-44.
- Lichtenberg M, de Graaf R, Erbel C (2018) Standards for recanalisation of chronic venous outflow obstructions. Vasa 47 (4): 259-266.
The Venovo™ Venous Stent System is indicated for the treatment of symptomatic iliofemoral venous outflow obstruction.
The Atlas™ Gold PTA Dilatation Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the peripheral vasculature, including the iliac arteries and iliac and femoral veins, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for post-dilatation of stents and stent franfts in the peripheral vasculature.
Please consult package insert for all indications, contraindications, hazards, warning, precautions, and information for use. © 2020 BD. BD, the BD logo, Atlas Gold, and Venovo™ are the property of Becton, Dickinson and Company.
Illustration by Mike Austin. Copyright © 2020.
Bard Peripheral Vascular, Inc. | www.bardpv.com | 1 800 321 4254 | 1625 W. 3rd Street Tempe, AZ 85281. BD-12870
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