Venous Stents Market

Venous Stents Market

Global venous stents market reached US$ YY million in 2023 and is expected to reach US$ YY million by 2031, growing at a CAGR of YY% during the forecast period 2024-2031.

Venous stents are metal mesh tubes that expand against blocked or narrowed vein walls. They act as a scaffold to keep veins open. Venous stenting is a minimally invasive procedure used to improve blood flow when a vein is narrowed or compressed. This helps restore healthy blood flow. They come in a variety of designs and sizes. Stents are usually delivered to their target area using a vascular catheter and in a compressed state. Some are self-expanding while others require the assistance of an inflated balloon.

Venous stents are typically used to resolve partial or complete reduction of blood flow within a blood vessel. Although stents may be used to treat a variety of conditions, one common reason for undergoing venous stenting is to treat post-thrombotic syndrome. This is a condition that can happen to people who have had a deep vein thrombosis of the leg. Sometimes, resolving a deep vein thrombosis results in damage to the vein which may partially or completely obstruct blood flow. In these cases, a stent may be used to support the damaged vessel. Other conditions such as May-Thurner’s Syndrome and Pelvic Congestion Syndrome among others might also require venous stenting.

Market Dynamics: Drivers

Rising advancements in venous stents

The rising advancements in venous stents are expected to drive the market over the forecast period. The continued innovations in venous stent design may lead to the development of self-expanding stent devices with improved flexibility, conformability and reduced rates of complications such as stent migration or restenosis. Stent designs that address specific anatomical challenges in venous diseases may become more prevalent.

For instance, on October 26, 2020, Medtronic plc cleared that it has received U.S. Food and Drug Administration (FDA) approval for the Abre venous self-expanding stent system. This device is indicated for use in the iliofemoral veins in patients with symptomatic iliofemoral venous outflow obstruction, also known as deep venous obstruction.

In addition, this self-expanding stent system, Abre is intended for a permanent implant and utilizes an open-cell design with three offset connection points to enable flexibility and stability during deployment. Abre also offers a balance of strength, flexibility and fatigue resistance. Based on data presented at the Leipzig Interventional Course (LINC) 2020 annual meeting and St. Thomas' Hospital and Kings College in London, the Abre stent system demonstrated a 0% fracture rate in bench testing simulated out to 50 years.

In addition, there are many ongoing research studies for the development of venous stents with next-generation technologies. For instance, on December 20, 2021, Vesper Medical, Increleased the completion of enrollment in its pivotal study, Venous Stent for the Iliofemoral Vein Investigational clinical trial using the Vesper DUO Venous Stent System (VIVID). The VIVID Trial enrolled its 160th patient. This marks the completion of enrollment in the VIVID Trial.

VIVID is a prospective, multi-center, single-arm study to evaluate the safety and efficacy of the Vesper DUO Stent System in the treatment of patients with iliofemoral occlusive disease. The Vesper DUO Stent System is designed to be the next-generation venous stent technology, uniquely engineered to address the challenges of deep vein obstruction. The modular portfolio is intended to provide physicians clinical versatility with both the DUO-HYBRID and DUO-EXTEND stent options in a full range of lengths and diameters to customize therapy for each patient depending on their specific disease location within the iliofemoral vein.

Further, the increasing prevalence of symptomatic iliocaval venous obstruction, rising FDA approvals for novel advanced stents, increasing clinical trials to develop venous stents, increasing awareness about the advantages of venous stents and increasing technological advancements are the factors expected to drive the market over the forecast period.

Restraints

Factors such as complications and side effects associated with venous stents such as stent migration, restenosis or thrombosis, the high cost of the stents, the availability of alternative treatments, limited awareness and unmet needs are the factors expected to hamper the market.

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Segment Analysis

The global venous stents market is segmented based on material, cell design, stent diameter, application, end-user and region.

The nitinol segment accounted for approximately 36.7% of the venous stents market share

The nitinol-based venous stents segment is expected to hold the largest market share over the forecast period. Nitinol-based venous stents are commonly used and the choice of nitinol as a material for these stents is based on its unique properties that make it well-suited for the demands of vascular interventions. Nitinol is an alloy of nickel and titanium, known for its superelasticity and shape memory characteristics.

For instance, the Venovo venous stent is a flexible nitinol stent specifically designed to reopen blocked iliac and femoral veins to maintain adequate blood flow. The Venovo venous stent is designed with a balance of radial strength, compression resistance and flexibility needed for the treatment of symptomatic post-thrombotic and non-thrombotic iliofemoral lesions. Additionally, the broad stent sizing allows clinicians to treat large-diameter veins and long lesion lengths.

Nitinol stents are highly flexible and exhibit excellent conformability. This flexibility is crucial in navigating through the complex anatomy of veins, allowing for easier deployment and optimal placement within the vessel. Nitinol possesses superelastic properties, allowing the stent to undergo large deformations and return to its original shape without permanent damage. This is especially important in areas where the veins may experience dynamic changes in shape and size, such as during movement.

For instance, on July 31, 2020, Bentley released the receipt of the CE Mark for its BeYond venous Self-Expanding Stent System, launching it first for commercial sale and clinical use in Europe. The launch will be limited to an exclusive circle of leading venous experts to gain first-hand experience with this novel device. The BeYond is an open-cell Nitinol stent, indicated for acute and chronic symptomatic obstructions of the femoral or iliac vein. It comes with a wide range of diameters from 10 to 18 mm and lengths up to 150 mm.

Geographical Analysis

North America accounted for approximately 41.3% of the market share

North America region is expected to hold the largest market share over the forecast period owing to the strong presence of major players and increasing demand for the venous stents in the region. North America especially the United States is a hub for the strong presence of major players like medical device companies. This presence of major players in the region focuses on the development of more advanced stents with advanced technologies.

For instance, on October 28, 2022, the GORE VIAFORT Stent, which has received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA), utilizes Gore’s proven and durable expanded polytetrafluoroethylene (ePTFE) technology in conjunction with a single-wound nitinol frame. The GORE VIAFORT Device Pivotal Clinical Study is evaluating the device in a treatment range of 10–28 mm diameter for iliofemoral veins and the inferior vena cava. The study is being conducted in the U.S. under an approved Investigational Device Exemption (IDE).

In addition, there is an increasing demand for venous stents in the region due to the increasing prevalence of deep vein thrombosis, iliocaval venous obstruction and post-thrombotic syndrome among others. For instance, according to the Centers for Disease Control and Prevention (CDC), the precise number of people affected by deep vein thrombosis (DVT) or pulmonary embolism (PE) is unknown, although as many as 900,000 people could be affected each year in the United States.

Competitive Landscape

The major global players in the venous stents market include Cook Medical, W. L. Gore & Associates, Inc., Boston Scientific Corporation, Becton, Dickinson and Company, Medtronic plc, Vesper Medical, Inc., optimed Medizinische Instrumente GmbH, Koninklijke Philips N.V., Bentley InnoMed GmbH and Shanghai MicroPort Medical (Group) Co. Ltd. among others.

COVID-19 Impact Analysis

The COVID-19 pandemic significantly impacted the global venous stents market. The COVID-19 increases both arterial and venous thrombogenicity. The SARS-CoV-2 hypercoagulable state may lead to a stent thrombosis triggered in the presence of other mechanical and biological risk factors. In addition, the pandemic also temporarily disrupted the research activities of venous stents and the supply chain of the venous stents was disrupted globally due to the redirected focus towards the virus spread.

Market Segmentation

By Material
• Nitinol
• Elgiloy
• Others

By Cell Design
• Open-Cell
• Closed-Cell
• Hybrid

By Stent Diameter
• 10 mm
• 12 mm
• 14 mm
• 16 mm
• 18 mm
• 20 mm
• 22 mm
• 24 mm
• Others

By Application
• Iliocaval Venous Obstruction
• Post-Thrombotic Syndrome
• Acute Iliofemoral Deep Vein Thrombosis
• Peripheral Artery Disease
• Symptomatic Venous Outflow Obstruction
• Others

By End-User
• Hospitals
• Specialty Clinics
• Academic and Research Institutes
• Others

By Region
• North America
U.S.
Canada
Mexico
• Europe
Germany
U.K.
France
Spain
Italy
Rest of Europe
• South America
Brazil
Argentina
Rest of South America
• Asia-Pacific
China
India
Japan
Australia
Rest of Asia-Pacific
• Middle East and Africa

Why Purchase the Report?
• To visualize the global venous stents market segmentation based on material, cell design, stent diameter, application, end-user and region as well as understand key commercial assets and players.
• Identify commercial opportunities by analyzing trends and co-development
• Excel data sheet with numerous data points of venous stents market-level with all segments.
• PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.
• Product mapping available as excel consisting of key products of all the major players.

The global venous stents market report would provide approximately 77 tables, 87 figures and 198 Pages.

Target Audience 2024
• Manufacturers/ Buyers
• Industry Investors/Investment Bankers
• Research Professionals
• Emerging Companies