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Varicose Vein Disease

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Published Date : Nov 2023
Category : Cardiovascular Diseases
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"Regulating Vein Health: Comparing Safety and Innovation"

Varicose veins are caused by poorly functioning vein valves and reduced flexibility of the vein wall, which allows blood to pool within the veins and cause them to grow. Varicose veins affect up to 40% of adults and are more prevalent in obese individuals and women who have had more than two pregnancies.

Varicose veins(VV) are dilated, palpable subcutaneous veins that have reversed blood flow and are most typically encountered in the legs. Varicose vein prevalence estimates differ. It is believed that at least one-third of the population has visible varicose veins in the lower limbs.

However, varicose veins are asymptomatic or produce only moderate symptoms in some people, but they cause discomfort, throbbing, or itching in others and can have a considerable impact on their quality of life.

The major symptoms of varicose veins are an achy or heavy feeling in the legs, Burning, throbbing, muscular cramping, and swelling in the lower legs, exacerbated discomfort after long periods of sitting or standing, itching around one or more veins, changes in skin tone around a varicose vein.

The root cause of varicose veins is unknown, however, their incidence increases with age and they frequently appear during pregnancy.

Furthermore, CDC report states that VVs are estimated to impact 33% of the general population aged 18 to 64 years. VVs are seen in 10%-15% of males and 20%-25% of women in Western countries. Epidemiology research conducted in the United States discovered that approximately 11 million men and 22 million women aged 40 to 80 had VVs.

The prevalence of varicose veins differs from region to region. A recent study done in Catalonia, Spain, examined a large-scale (5.8 million) population and found greater than 5.6% prevalence and an incidence of 4.62 persons per year of VVs.

Moreover, NIH states that several surveys have been performed in Asia, with one in Japan revealing a 45% prevalence rate of VVs ranging from moderate to severe. However, it is estimated that 33% of the population in the United Kingdom has VVs of the lower legs.

In addition to that, in Shanghai, China, a survey of 30,712 patients over the age of 15 who worked in various industries revealed a prevalence rate of 8.39% of VVs 20, whereas a study in Tehran, Iran, revealed a 36% prevalence rate of VVs in the same age groups. 21 Another research in southern Taiwan found a prevalence rate of VVs in the lower legs of 24.2% as stated by NIH.

However, varicose veins get worse with time, resulting in consequences such as skin color changes, dermatitis, superficial thrombophlebitis, hemorrhage, loss of subcutaneous tissue, lipodermatosclerosis, or venous ulcers.

The literature has little accurate information on the proportion of persons with varicose veins who develop venous ulcers. After 6.6 years, 28.6% of individuals with obvious varicose veins but no edema or other problems progressed to more significant venous disease, according to one research report at NIH.

However, according to data stated in NIH, the lifetime prevalence of varicose veins is around 3-6% of those with varicose veins will develop venous ulcers.

Varicose veins continue to be a common vascular problem, affecting a considerable proportion of the population, with major demographic differences. Emerging developments in minimally invasive therapies are gaining commercial momentum, providing patients with less intrusive and more efficient choices.

The market for varicose vein treatments and diagnosis is expanding, providing prospects for development for healthcare providers and industry players. However, addressing the issues of accessibility, cost, and fair treatment for all patient groups is critical.

Future studies should concentrate on gaining a better knowledge of the genesis of varicose veins as well as the long-term results of new treatment techniques. Overall, this service report emphasizes the importance of a comprehensive strategy for treating and diagnosing varicose veins, both epidemiologically and commercially.

DiseaseLandscape Insights aids in making thoughtful choices in the realm of medical technology, therapies, and diagnostics, where diverse technologies and cutting-edge advances modify the varicose veins disease landscape, resulting in more growth.

Diagnostic Analysis of Varicose Vein Disease

"Precision in Vein Evaluation: The Pioneering Varicose Vein Diagnosis"

Varicose vein disease diagnostic tests are often used to confirm the presence of varicose veins, determine their severity, and plan suitable therapy. Here are some of the most important varicose vein diagnostic tests listed below:

  1. Physical Examination

A complete physical examination is performed by a healthcare professional, which involves assessing the appearance of the struck veins, looking for swelling, discomfort, or skin changes, and discussing the patient's medical history and symptoms.

  1. Doppler Ultrasonography

Doppler ultrasonography is a non-invasive technique that employs sound waves to produce pictures of blood flow in veins, Doppler ultrasonography is widely utilized. It aids in determining the amount and location of venous insufficiency or reflux, which is a major underlying cause of varicose veins.

  1. Venous Duplex Scan

Venous duplex scan test combines conventional and Doppler ultrasonography to offer anatomical and functional information about veins. It aids in determining the direction and rate of blood flow in afflicted veins.

  1. Magnetic Resonance Venography (MRV)

MRV is a more sophisticated imaging method that uses magnetic resonance imaging (MRI) to provide detailed pictures of veins in the legs. It reveals important details regarding the structure and blood flow in the afflicted veins.

  1. Computational Tomography

CT venography creates pictures of the veins in the legs using a CT scanner. It is less widely utilized than ultrasound and MRV, although it is beneficial in some instances.

  1. Contrast Venography

In this invasive procedure, a contrast dye is injected into a major vein in the foot or ankle, and X-ray pictures are taken while the dye travels up the leg. It is normally reserved for instances where other diagnostic tests are equivocal or when more sophisticated therapies are planned.

The diagnostic test used is determined by the clinical presentation, the provider's experience, and the precise information required for treatment planning. Because of its non-invasiveness and efficacy in evaluating varicose veins, Doppler ultrasonography, and venous duplex scanning are frequently used as first-line diagnostics.

These diagnostic tests assist healthcare practitioners in determining the best treatment strategy, which includes lifestyle adjustments, compression stockings, or more invasive treatments like endovenous laser treatment or sclerotherapy.

Numerous potentials exist for companies to enhance diagnosis, patient interaction, and treatment planning in the diagnostic field of varicose vein disease. Varicose veins are a prevalent vascular issue, and as knowledge and understanding of them increase, so does the opportunity for innovation and patient-centered treatments.

The below table shows the names of market players who are transforming varicose vein disease and their innovative product names.

Diagnostic Market Player

Diagnostic Products

GE Healthcare

GE Logiq E9 with XDclear

Siemens Healthineers

Siemens Acuson X700

Philips Healthcare

Philips EPIQ 7

Samsung Medison

Samsung Medison RS80A

Shimadzu Corporation

Trinias C16

Esaote S.p.A

MyLab™ Twice

Toshiba Medical Systems Corporation

Aplio i900

Mindray

Mindray DC-8

Hitachi Healthcare

Hitachi Arietta V70

 

Treatment Analysis of Varicose Vain Disease

"Elevating Medical Care: Revolutionary Varicose Vein Treatments"

The treatment option is determined by the size and location of the varicose veins, the patient's overall health, and the advice of a healthcare practitioner. It is critical to talk with a healthcare expert to identify the best treatment approach for your unique situation.

Varicose vein disease is treated using a variety of methods, ranging from conservative approaches to more invasive operations. Below are the treatment options available in the market for varicose vein disease.

  1. Sclerotherapy

Sclerotherapy is performed to eradicate the varicose vein from the patient’s body. During the procedure, a special solution is injected into the varicose vein that results in the collapsing and fading of the varicose vein. The specialized sclerotherapy called foam sclerotherapy is used to treat the varicose vein in which foam solution is injected into the patient’s body.

  1. Venous Stenting

Venous stenting, which is frequently done in situations of deep vein thrombosis (DVT) and venous ulcers, involves inserting a stent into a constricted or obstructed vein to enhance blood flow.

  1. Endovenous Laser Ablation (EVLA)

The endovenous laser ablation technique uses laser energy from the source to eradicate or ligate the infected vein. It also redirects the blood flow towards the normal and healthy vein to improve the health of the patient. However, radiofrequency ablation (RFA) uses radiofrequency as an energy source to close or remove abnormal veins.

  1. Venous Stripping

Venous stripping is the surgical procedure to treat the varicose vein disease. During surgery, the affected vein is removed from the body, generally from the leg by using small incisions.

  1. Endoscopic Vein Surgery

Endoscopic vein surgery is an invasive surgical technique in which an endoscope is used to join or remove the vein in the patient’s body. Endoscopic vein surgery is performed when severe cases are observed.

The market participants have tremendous opportunities in the treatment field of varicose vein disease to develop a sustainable business and expand the business globally. Research on minimally invasive treatment options, cosmetic enhancement, novel drug development, telemedicine, and cell therapies like stem cell therapy are the general areas where the key players have scope to develop their businesses.

DLI services provide knowledge, direction, and assistance in a range of areas to effectively manage this complex healthcare environment and take advantage of business prospects. Market participants in the varicose vein disease treatment sector need to better manage challenges, capture opportunities, and establish essential plans for long-term growth and success by using the experience and industry knowledge of DLI services.

The below table provides the names of key players in the treatment of varicose vein disease and their innovative product names.

Treatment Key Player

Products

Medtronic

ClosureFast™ Radiofrequency Ablation (RFA) System

Boston Scientific

Varithena

Lumenis

Duetto MT

Cook Medical

Stents, Catheters, and Wires

Alma Lasers

Accent Prime

Dornier MedTech

Dornier D940 Laser System

BTG International

Ekosonic™ Endovascular System

Covidien

Covidien VNUS ClosureFAST™ System

Biocompatibles International

BTG Microspheres

 

Regulatory Framework of Varicose Vein Disease

"Mapping the Regulatory Authorization: Recognizing the Business Practices"

The role of regulatory organizations in licensing and regulating venous therapies is crucial to the field's progress. Patients and medical professionals benefit from the most recent FDA, EMA, and other approvals, which give safer and more effective venous therapy alternatives. Patients make well-informed judgments regarding their venous treatment options by remaining educated and engaging with trusted healthcare specialists. The most recent FDA approvals and restrictions are changing vein treatment procedures in a variety of ways.

The FDA has authorized a number of minimally invasive vein therapies in recent years, including endovenous laser therapy (EVLT) and radiofrequency ablation (RFA). Because of their efficacy and quicker recovery periods, these approaches have become more popular as less intrusive alternatives to typical surgical procedures for treating varicose veins.

The FDA has also authorized novel sclerotherapy treatments for the treatment of spider and small varicose veins. These solutions are more effective and less undesirable, which improves the patient's experience both during and after therapy.

The FDA-approved Vena-Seal Closure System is an adhesive therapy for venous reflux disease. This technique seals the damaged vein using medical glue, providing patients with a less invasive and extremely successful therapy alternative.

Aside from treatment approvals, the FDA enforces standards in order to ensure the overall safety and efficacy of vein therapies. The rules are in place to preserve patients' well-being and the medical field's credibility.

For the manufacture and delivery of vein therapy techniques and equipment, the FDA establishes severe quality control criteria. This guarantees that patients receive therapies that are both safe and dependable.

Competitive Analysis of Varicose Vein Disease

"Elevating the Effectiveness: Perceptions into Varicose Vein Contributors"

The competitive analysis of varicose vein disease entails evaluating the market's top competitors, their strengths, weaknesses, market share, product offers, and strategies.

Varicose vein disease market competitors are always adapting to evolving patient demands, technology breakthroughs, and laws and regulations. DiseaseLandscape Insights consulting services offer industry research, trade magazines, and professional networks to keep you informed of market trends.

However, a significant player in the medical technology industry, Medtronic offered solutions for varicose vein disease, including the ClosureFast™ Radiofrequency Ablation (RFA) device. This device uses radiofrequency radiation to seal off troublesome veins in order to treat varicose veins minimally invasively. Development of such products has increased the awareness of products in the general public. Also, the overall revenue of Medtronic Company has increased after launching of such an innovative product.

Moreover, competitors like AngiDynamics are also working in the treatment sector of varicose vein disease. This company offers the VenaCure EVLT™ (Endovenous Laser Treatment) system which uses laser energy to cure varicose vein disease. Research, development, and marketing of this product help the company expand of product portfolio.

In addition to that many market players like BTG International, Lumenis, Cook Medical, and so on are working in the diagnostic as well as treatment sector of varicose vein disease. These companies are implementing the best business strategies, product marketing, and innovative approaches to expand their business and establish competitiveness in the varicose vein disease market. 

DiseaseLandscape Insights helps industry organizations by providing detailed knowledge about all current market participants, their research, strategies, and alliances. It also aids in the grasping of the best market opportunities to grow exponentially and globally.

Market Trends

“Reading Trends Anew: Where Vein Care unites with Profitable Knowledge”.

In emerging economies, where the middle class was increasing and the healthcare infrastructure was strengthening, varicose vein treatments and diagnostic markets were becoming more and more popular. The healthcare business was able to take advantage of these markets.

However, owing to technological breakthroughs, varicose vein therapy has become more and more minimally invasive and successful. Compared to more conventional surgical methods, procedures including radiofrequency ablation (RFA), sclerotherapy, and endovenous laser treatment (EVLT) were becoming more and more popular since they provided shorter recovery periods and less pain.

Treatment for varicose veins is becoming more and more popular for aesthetic purposes, especially among those who want to improve the appearance of their legs. The need for therapies with an aesthetic focus was being driven by this trend.

Moreover, companies are placing funds in research and development to produce new and more effective varicose vein treatment procedures. Medical device, material, and procedure innovations were being investigated in order to improve patient outcomes.

Over-the-counter (OTC) medications and home remedies for varicose vein symptom alleviation, such as compression stockings, lotions, and vitamins, are being investigated by certain patients. Cost reasons and a preference for non-invasive methods are driving this trend.

Clinical Trial Assessment

The government’s initiatives and emphasis on advancements in clinical trials promote the key players to do concentrated clinical research on the drug or medical device. To transform the healthcare sector and launching of novel products is now considered at the top by various industry players.

The below table shows the phases of a clinical trial for varicose veins disease and the title of a clinical trial.

Phase I

Phase II

Phase III

Phase IV

Phase I-II, Multicenter, Randomized, Controlled, Proof of Concept Clinical Trial to Determine Feasibility, Safety and Efficacy of the Use of Allogenic Adipose-derived Adult Mesenchymal Stem Cells Expanded on Fibrinhyaluronic Biological Matrix in the Treatment of Venous Ulcer of the Lower Limbs

Randomized Controlled Trial of Carvedilol Versus Endoscopic Band Ligation for Primary Prophylaxis of Oesophageal Variceal Bleeding in Cirrhotic Patients With Arterial Hypertension

Randomized Controlled Trial of Carvedilol Versus Endoscopic Band Ligation for Primary Prophylaxis of Oesophageal Variceal Bleeding in Cirrhotic Patients With Arterial Hypertension

A Prospective, Open-label, Pragmatic Randomized Controlled Trial to Demonstrate the Effect of Improving the Venous Reflux Time by Vitis Vinifera Seed Extract in Patients With Varicose Vein of Lower Extremity

A Multi-centre, Randomised, Single-blind Phase I/IIa Study to Evaluate the Safety, Tolerability and Efficacy of a Single Topical Dose of Allogeneic Integrin α10β1-selected Mesenchymal Stem Cells (XSTEM-VLU) in Patients With Difficult-to-heal Venous Leg Ulcers

Phase I-II, Multicenter, Randomized, Controlled, Proof of Concept Clinical Trial to Determine Feasibility, Safety and Efficacy of the Use of Allogenic Adipose-derived Adult Mesenchymal Stem Cells Expanded on Fibrinhyaluronic Biological Matrix in the Treatment of Venous Ulcer of the Lower Limbs

The Potential Role of Allopurinol Versus Atorvastatin to Prevent Complications of Liver Cirrhosis: A Quadruple Blind Clinical Study

Randomised Controlled Trial of Foam Sclerotherapy Versus Ambulatory Phlebectomy for the Treatment of Varicose Vein Tributaries

 

A Multi-centre, Randomised, Single-blind Phase I/IIa Study to Evaluate the Safety, Tolerability and Efficacy of a Single Topical Dose of Allogeneic Integrin α10β1-selected Mesenchymal Stem Cells (XSTEM-VLU) in Patients With Difficult-to-heal Venous Leg Ulcers

 

A Phase 4 Randomized Trial Comparing Varithena to Endothermal Ablation for the Treatment of the Great Saphenous Vein

 

A Randomized, Double-Blind, Placebo-controlled, Parallel, Phase II Study to Evaluate Efficacy and Safety of ENERGI-F703 GEL in Subjects With Venous Leg Ulcer (VLU)

 

Antibiotic Prophylaxis in Patients Undergoing Endoscopic Injection of Cyanoacrylate for Primary and Secondary Prevention of Gastric Variceal Bleeding

 

A Randomized, Placebo-Controlled, Double-blind, Dose-Ranging, Multicenter, Phase IIb Clinical Trial to Investigate the Efficacy and Safety of Allo-APZ2-CVU on Wound Healing of Therapy-Resistant Chronic Venous Ulcer (CVU)

 

Comparison of 24-hours Versus 72-hours of Octreotide Infusion Along With Endoscopic Therapy in Preventing Early Rebleed From Esophageal Varices: a Multi-center, Randomized Clinical Study

 

The Potential Role of Allopurinol Versus Atorvastatin to Prevent Complications of Liver Cirrhosis: A Quadruple Blind Clinical Study

 

 

 

Conclusion

Recognizing the significance of Disease Landscape Insights (DLI), particularly in the fight against varicose vein disease, is paramount. DLI services are tailored to assist the healthcare sector, its professionals, researchers, and key stakeholders in improving patient outcomes and facilitating business expansion and advancement.

DLI services give important knowledge about the most current advances, treatment techniques, and developing patterns in varicose vein disease control by utilizing the power of substantial market research. Furthermore, DLI services act as an amplifier for cooperation and innovation, enabling collaborations between industry stakeholders and researchers to accelerate developments in varicose vein disease treatment and prevention.

All in all, in-depth research of DLI allows market players to perform advanced research and stay stronger and one step ahead in the crowded diagnostic as well as treatment market of varicose vein disease.

SUMMARY
VishalSawant
Vishal SawantBusiness Development
vishal@diseaselandscape.com

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