North America Bioresorbable Coronary Stents Market – Segmented By Brand (Magmaris, Magnitude, MeRes100, DESolve, Others), By Region, Competition, Forecast, Opportunities, 2018-2028F

Market Overview

North America Bioresorbable Coronary Stents Market has valued at USD 45.24 million in 2022 and is anticipated to project robust growth in the forecast period with a CAGR of 15.29% through 2028. The North America bioresorbable coronary stents market represents a rapidly evolving segment within the broader medical device and cardiovascular healthcare industry. Bioresorbable coronary stents, also known as bioresorbable vascular scaffolds (BVS), are medical implants used to treat coronary artery disease (CAD). These stents are designed to provide temporary support to diseased coronary arteries and then gradually dissolve over time, leaving no permanent implant behind. This approach differs from traditional metallic stents, which remain in the body indefinitely.

Key Market Drivers

Clinical Benefits and Superior Outcomes

Clinical benefits and superior outcomes play a crucial role in driving the growth of the North America bioresorbable coronary stents market. These benefits stem from the unique characteristics and mechanisms of action of bioresorbable stents, which differentiate them from traditional metallic stents. Bioresorbable coronary stents, or bioresorbable vascular scaffolds (BVS), offer a significant advantage by gradually dissolving in the body after serving their initial purpose of keeping a coronary artery open. Unlike metallic stents, which remain in the body permanently, bioresorbable stents are designed to be absorbed over time. This dissolution eliminates the risk of late complications often associated with metallic stents, such as in-stent restenosis (narrowing of the stented artery) and stent thrombosis (blood clot formation within the stent). As a result, patients who receive bioresorbable stents experience a lower incidence of these complications, leading to improved long-term clinical outcomes.

Patients who receive metallic stents are typically required to take dual antiplatelet therapy (usually aspirin and a P2Y12 inhibitor) for an extended period, often up to one year or more, to prevent blood clots around the stent. In contrast, bioresorbable stents have the advantage of dissolving over time, eliminating the need for prolonged DAPT. This is especially beneficial for patients who are at a higher risk of bleeding complications associated with antiplatelet therapy. The reduced duration of DAPT enhances patient compliance and overall safety. Bioresorbable stents promote better vessel healing and restoration of natural vessel function. Because they eventually dissolve, the artery can return to its natural state, allowing for vasomotion (the ability of the artery to constrict and dilate), which is not possible with permanent metallic stents. This improved vessel healing and functionality can result in a reduction of angina (chest pain) and improved overall cardiac function for patients, contributing to superior clinical outcomes.

Patients who receive bioresorbable coronary stents often report a better quality of life compared to those with metallic stents. The absence of a permanent implant in the body means that patients do not experience the discomfort or awareness of a foreign object inside them. This can lead to improved overall well-being, reduced anxiety, and increased satisfaction with their medical treatment. Bioresorbable stents are particularly attractive to younger and more active patient populations. These individuals may have concerns about the long-term implications of metallic stents on their quality of life and ability to engage in physical activities. The clinical benefits of bioresorbable stents, with their potential for reducing late complications and the need for long-term medication, make them an appealing choice for such patients.

Growing Prevalence of Coronary Artery Disease

The growing prevalence of coronary artery disease (CAD) is a significant driver for the growth of the North America bioresorbable coronary stents market. Coronary artery disease is a widespread cardiovascular condition that affects millions of people worldwide, and the demand for effective treatment options has been on the rise. Over the past few decades, there has been a steady increase in the incidence of CAD, particularly in developed and developing nations. This trend can be attributed to a range of factors, including sedentary lifestyles, unhealthy diets, smoking, and an aging population. CAD is a leading cause of morbidity and mortality North Americaly, with significant economic and healthcare burdens.

The aging of the North America population is a significant contributor to the increasing prevalence of CAD. As people age, the risk of developing CAD rises due to the cumulative effects of risk factors over time. The elderly population often presents complex medical needs, making the treatment of CAD an important part of healthcare systems worldwide. Lifestyle-related risk factors such as obesity, diabetes, hypertension, and high cholesterol are becoming more prevalent, leading to an increased risk of CAD. These risk factors are often interrelated, compounding the problem and necessitating effective treatment options for patients.

There is a growing awareness of the importance of early diagnosis and treatment of CAD. Advances in medical imaging and diagnostic techniques have made it easier to identify CAD at an earlier stage, allowing for timely intervention and treatment. As more individuals are diagnosed with CAD, the demand for effective treatment options, including bioresorbable coronary stents, continues to rise. The treatment landscape for CAD has seen significant advancements, including innovations in percutaneous coronary intervention (PCI), which is the procedure used to implant stents. Bioresorbable coronary stents have emerged as an innovative option, and their adoption is likely to increase as the demand for more advanced treatment modalities grows in response to the rising prevalence of CAD.

Advancements in Technology and Materials

Advancements in technology and materials are significant drivers for the growth of the North America bioresorbable coronary stents market. These advancements have led to the development of more innovative and reliable bioresorbable stents, making them an attractive option for both patients and healthcare providers. The choice of materials is a crucial factor in the development of bioresorbable coronary stents. Advances in biodegradable polymers and materials have allowed for the creation of stents with enhanced strength, flexibility, and degradation properties.

Bioresorbable stents are typically made from materials such as polylactic acid (PLA) or polyglycolic acid (PGA), which gradually degrade in the body. Researchers have made substantial progress in optimizing the properties of these materials to ensure they provide sufficient mechanical support to the artery while also allowing for controlled, predictable degradation. Technological advancements have paved the way for more intricate and optimized stent designs. These designs are tailored to improve deliverability and conformability during the stent implantation procedure, minimizing complications and ensuring a more successful outcome. Advanced computer-aided design (CAD) and simulation tools have enabled the development of intricate stent architectures that balance mechanical strength with biodegradability. Such designs are essential for ensuring proper blood flow within the treated vessel.

Many bioresorbable coronary stents incorporate drug-eluting capabilities to prevent restenosis (re-narrowing of the treated vessel). Technological advancements in drug-eluting stents have led to more precise and controlled drug release profiles, reducing the risk of side effects and optimizing therapeutic efficacy. Improved drug-eluting capabilities have also allowed for personalized medicine approaches, tailoring drug delivery to individual patient needs based on their specific vascular characteristics. Innovations in manufacturing techniques have made it possible to produce bioresorbable stents with greater precision, consistency, and quality. This is crucial for ensuring that each stent meets rigorous safety and performance standards. Cutting-edge manufacturing processes, such as laser cutting and 3D printing, have become integral in producing stents with complex designs and the desired mechanical properties. These techniques enable the production of stents that are highly customizable to the patient's anatomy.

Regulatory Support and Approvals

Regulatory support and approvals are crucial drivers for the growth of the North America bioresorbable coronary stents market. These factors create a foundation of credibility and trust, facilitating the adoption of innovative medical devices like bioresorbable stents. Regulatory bodies, such as the U.S. Food and Drug Administration (FDA) in the United States and the European Medicines Agency (EMA) in Europe, play a fundamental role in evaluating and approving medical devices. Their stringent review processes ensure that bioresorbable stents meet high safety and efficacy standards before they can be marketed to healthcare professionals and patients. Regulatory approvals provide assurance to healthcare providers that bioresorbable stents have undergone rigorous testing, reducing concerns about the safety and performance of these devices. This confidence is pivotal for their acceptance and adoption in clinical practice.

Regulatory approvals bestow credibility upon bioresorbable stents. When these stents receive clearance or approval from major regulatory authorities, they gain recognition as reliable and effective medical devices. This, in turn, encourages healthcare providers to integrate them into their treatment protocols. Regulatory support also reassures investors and stakeholders, fostering financial backing and partnerships that are essential for research, development, and market expansion. Bioresorbable stents that have gained regulatory approval have a competitive edge in the market. They can differentiate themselves from non-approved or less-regulated alternatives, attracting a broader range of potential users. Regulatory support allows manufacturers to market their products as safe and efficacious, which is a significant selling point in the competitive landscape of medical devices.

International recognition through regulatory approvals facilitates market expansion. Manufacturers can access a broader customer base, including healthcare providers and patients in different countries. The North America harmonization of regulatory standards helps streamline the process of gaining approvals in multiple regions, enabling companies to reach a wider audience and increase market penetration. Regulatory approvals encourage healthcare professionals to consider bioresorbable stents as a viable treatment option. They trust that the devices have met the stringent requirements of regulatory agencies, which helps drive clinical adoption. With the backing of regulatory support, clinicians are more likely to recommend bioresorbable stents to their patients, increasing the utilization of these devices in coronary artery disease treatment.

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Key Market Challenges

Limited Long-Term Clinical Data

One of the primary challenges facing bioresorbable coronary stents is the limited long-term clinical data available. While these stents have demonstrated promising results in terms of safety and short-to-medium-term efficacy, there is a need for more extensive, long-term clinical evidence to support their use. The dissolution process of bioresorbable stents, while intended to eliminate long-term complications associated with metallic stents, has raised concerns about the possibility of late scaffold discontinuity or late events after complete bioresorption. This uncertainty can deter healthcare providers and patients from fully embracing bioresorbable stents. Conducting long-term clinical trials and monitoring patients for an extended period is resource-intensive, and it takes time to accumulate meaningful data. This challenge can slow down the market growth as stakeholders wait for more comprehensive evidence of the long-term safety and efficacy of these devices.

Cost and Reimbursement Challenges

Bioresorbable coronary stents are often more expensive than traditional metallic stents. The higher cost can present a barrier to adoption, especially in regions with cost-conscious healthcare systems or where patients have limited access to insurance coverage. Reimbursement challenges further compound this issue. Healthcare reimbursement policies and reimbursement rates for bioresorbable stents vary from one country to another. Uncertainty surrounding reimbursement can deter healthcare providers from adopting these devices, as they may be concerned about the financial implications. Manufacturers of bioresorbable stents must work on cost-effective production methods to reduce the overall cost and navigate the complexities of reimbursement policies to ensure market access.

Technical and Procedural Challenges

The deployment of bioresorbable stents can be technically challenging. Their thinner struts and different mechanical properties compared to metallic stents require specialized training and expertise for interventional cardiologists. This can limit the widespread adoption of bioresorbable stents, particularly in regions where access to training and expertise is limited. Stent thrombosis, though rare, remains a concern. Ensuring proper implantation technique and addressing issues related to stent thrombosis are important to enhance safety. These technical challenges need to be addressed through continuous medical education and improved device design. Bioresorbable stents are also more fragile than metallic stents and can be prone to damage during handling, transport, and implantation. Ensuring the integrity of the stent throughout the supply chain and during the procedure is critical.

Key Market Trends

Increasing Focus on Personalized Medicine

One significant trend in the bioresorbable coronary stents market is the growing emphasis on personalized medicine. Healthcare providers are increasingly recognizing that each patient's coronary anatomy and disease presentation are unique. As a result, there is a shift toward tailoring treatment strategies, including stent selection, to individual patient needs. Bioresorbable stents offer the advantage of customization. Physicians can select the appropriate stent size, length, and design based on a patient's specific coronary anatomy. This trend toward personalized medicine ensures that patients receive the most suitable treatment, optimizing outcomes and reducing the risk of complications.

Integration of Advanced Imaging and Navigation Technologies

The integration of advanced imaging and navigation technologies is another key trend in the bioresorbable coronary stents market. Innovations in intravascular imaging techniques, such as optical coherence tomography (OCT) and intravascular ultrasound (IVUS), have enabled interventional cardiologists to better assess coronary lesions and stent deployment. These imaging technologies help ensure precise stent placement, reduce the risk of complications, and support optimal patient outcomes. They also play a crucial role in assessing vessel healing and confirming the gradual resorption of bioresorbable stents, enhancing the safety and efficacy of these devices.

Rise of Drug-Eluting Bioresorbable Stents

Drug-eluting bioresorbable stents have gained prominence as a significant trend in the market. These stents are designed to not only provide mechanical support but also deliver therapeutic drugs that inhibit restenosis and promote healing of the treated vessel. The development of innovative drug-eluting technologies has led to more precise and controlled drug release profiles. As a result, bioresorbable stents can address the challenge of in-stent restenosis effectively, offering a solution to a common complication associated with metallic stents. The combination of mechanical support and drug delivery in bioresorbable stents represents a promising approach to improving patient outcomes and has been driving interest in these devices.

Segmental Insights

Brand Insights

Based on the category of Brand, the MeRes100 segment emerged as the dominant player in the North America market for Bioresorbable Coronary Stents in 2022. MeRes100 is celebrated for its clinical innovation. It has undergone rigorous clinical trials to demonstrate its efficacy and safety. Clinical evidence supporting the effectiveness of MeRes100 has been published, which has a positive impact on its adoption by healthcare providers.

Its innovative design and controlled degradation process contribute to better vessel healing and restoration of natural vessel function, potentially reducing complications associated with stent placement. This clinical efficacy positions MeRes100 as a compelling choice for interventional cardiologists and their patients. MeRes100 incorporates unique technological advancements that set it apart from other bioresorbable stents. Its proprietary polymer formulation and manufacturing processes have been optimized to ensure controlled and predictable stent degradation, addressing concerns about late scaffold discontinuity. These technological advantages contribute to the appeal of MeRes100 as a next-generation bioresorbable stent, which may attract healthcare providers and patients looking for state-of-the-art treatment options.

MeRes100 has undergone regulatory approvals in various regions, including CE Mark approval in Europe, which is essential for marketing and sales in the European Union. Regulatory approvals help establish MeRes100 as a North Americaly recognized and trusted medical device. As MeRes100 continues to gain regulatory clearances in different markets, its availability and adoption are likely to expand, contributing to its dominance in the North America bioresorbable coronary stents market. The MeRes100 brand stands out through its differentiation from other bioresorbable stents in the market. Its distinct features, such as advanced imaging compatibility, excellent radial strength, and gradual resorption profile, provide advantages in terms of safety and efficacy. Market differentiation allows MeRes100 to address the unique needs of both physicians and patients, potentially making it the preferred choice in a competitive landscape. Meril Life Sciences has actively engaged in educational initiatives and physician training programs to familiarize interventional cardiologists with MeRes100. These efforts are crucial in promoting its adoption and use in clinical practice. As more physicians become trained and experienced in using MeRes100, its presence and dominance in the market are likely to increase. These factors are expected to drive the growth of this segment.

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Regional Insights

United States emerged as the dominant player in the North America Bioresorbable Coronary Stents market in 2022, holding the largest market share in terms of value. The region boasts a sophisticated healthcare infrastructure, encompassing hospitals, clinics, and specialized cardiac centers. These facilities are equipped with state-of-the-art technology and staffed by highly skilled healthcare professionals adept in performing coronary procedures. Furthermore, the United States maintains a robust healthcare system that actively fosters technological advancements and innovations. It serves as the headquarters for several prominent medical device companies that make substantial investments in research and development, thereby propelling the progress of bioresorbable coronary stents. The presence of cutting-edge technologies and a wealth of expertise in this region underpins its dominance in the market. However, the United States lags behind, with limited prominence in this sector.

The Canada market is poised to be the fastest-growing market, offering lucrative growth opportunities for Bioresorbable Coronary Stents players during the forecast period. Factors such as the increasing numbers of coronary stenting procedures due to the substantial patient population afflicted with cardiovascular diseases, the area is also experiencing a swift uptake of CE and FDA-approved devices. This, in turn, results in robust regional sales revenue for bioresorbable coronary stents. Also, the region has made significant investments in enhancing its healthcare infrastructure, which includes the establishment of modern hospitals, cardiac centers, and catheterization laboratories equipped with state-of-the-art medical technologies. These developments empower healthcare providers to deliver high-quality treatments, including the utilization of bioresorbable coronary stents, to their patients. The presence of such facilities fosters the expansion of the market.

Recent Developments

• In October 2023 - Boston Scientific Announces Results from the North America, Randomized, Controlled EMBOLDEN Trial Demonstrating the Safety and Effectiveness of the Watchman FLX Left Atrial Appendage Closure Device (LAAC Device) for the Prevention of Stroke in Patients with Atrial Fibrillation Not Suitable for Warfarin.
• In August 2023, Medtronic presents new data from its Evolut Low Risk Trial at the Transcatheter Cardiovascular Therapeutics (TCT) conference, showing that the Evolut TAVR platform is superior to surgery for low-risk patients.   
• In October 2023, Cordis receives FDA approval for its new PROMUS Element+ stent, the first stent to combine two different drug eluting technologies to reduce the risk of restenosis, or blockages, in the arteries after stenting.

Key Market Players

• Boston Scientific Corporation
• Medtronic Inc.
• Cordis Corp
• Biotronik Inc.
• Meril Life Sciences Pvt. Ltd.
• Abbott Laboratories Ind.
• Elixir Medical Corp
• REVA Medical, LLC
• Arterial Remodeling Technologies SA

Report Scope:

In this report, the North America Bioresorbable Coronary Stents Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• North America Bioresorbable Coronary Stents Market, By Brand:

o   Magmaris

o   Magnitude

o   MeRes100

o   DESolve

o   Others

• North America Bioresorbable Coronary Stents Market, By Region:

o   United States

o   Canada

o   Mexico

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the North America Bioresorbable Coronary Stents Market.

Available Customizations:

North America Bioresorbable Coronary Stents market report with the given market data, Tech Sci Research offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

• Detailed analysis and profiling of additional market players (up to five).

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