Patent Ductus Arteriosus (PDA) Occlusion Devices Market Size, Production, Sales, Average Product Price, Market Share, Import vs Export 

Emerging Trends in the Patent Ductus Arteriosus (PDA) Occlusion Devices Market 

Patent Ductus Arteriosus (PDA) Occlusion Devices market size is estimated to be $126 Million in 2025. The market was $118 Million in 2024 and will reach $196 Million by 2032.
The Patent Ductus Arteriosus (PDA) Occlusion Devices Market is witnessing significant evolution driven by technological advancements and increasing clinical adoption. One of the key trends reshaping this market is the rise in minimally invasive procedures. For instance, the growing preference for catheter-based interventions over traditional surgery has catalyzed demand for PDA occlusion devices that offer improved patient outcomes with reduced recovery times. This shift is particularly evident in neonatal and pediatric cardiology, where the incidence of PDA—a congenital heart defect affecting approximately 1 in 2000 full-term infants—is prompting greater utilization of occlusion devices. 

The sophistication of device design, such as the integration of biodegradable materials and enhanced delivery systems, also marks a notable trend. Such innovations are reducing complication rates and expanding the application of PDA occlusion devices to a broader patient demographic. For example, devices incorporating nitinol mesh frameworks allow for improved conformability to patient anatomy, thereby enhancing closure success rates and minimizing residual shunting post-procedure. 

 

Market Drivers Fueling Growth in the Patent Ductus Arteriosus (PDA) Occlusion Devices Market 

The Patent Ductus Arteriosus (PDA) Occlusion Devices Market growth is underpinned by several critical drivers. Foremost is the increasing global prevalence of congenital heart anomalies, with PDA constituting a significant share. For instance, epidemiological studies highlight that preterm infants exhibit a higher incidence rate of PDA, estimated at 20–60%, which intensifies demand for effective occlusion solutions in neonatal intensive care units. 

Additionally, the expanding geriatric population presents a secondary driver, as late-diagnosed or untreated PDA cases in adults are increasingly addressed via percutaneous occlusion. This shift has been observed in developed healthcare markets where routine screening and improved diagnostic modalities have elevated detection rates. 

Advances in imaging technologies, such as three-dimensional echocardiography and cardiac MRI, further empower clinicians to accurately assess PDA anatomy and select appropriate occlusion devices, thus driving adoption. For example, integration of real-time imaging during device deployment enhances procedural success, contributing to the market’s expansion. 

 

Impact of Healthcare Infrastructure and Regional Dynamics on the Patent Ductus Arteriosus (PDA) Occlusion Devices Market 

The Patent Ductus Arteriosus (PDA) Occlusion Devices Market exhibits pronounced regional variations, shaped largely by healthcare infrastructure and economic factors. In North America and Europe, well-established cardiac care facilities and high patient awareness fuel steady demand for advanced PDA occlusion devices. For example, the United States accounts for a substantial share of market revenue due to widespread use of transcatheter closure procedures supported by reimbursement frameworks. 

Conversely, emerging economies in Asia-Pacific, such as India and China, are poised for rapid growth in the Patent Ductus Arteriosus (PDA) Occlusion Devices Market. This surge is driven by increasing healthcare investments, rising birth rates, and expanding access to specialized pediatric cardiology services. For instance, initiatives to improve neonatal care and the establishment of dedicated cardiac centers are accelerating adoption of PDA occlusion devices in these regions. 

 

Technological Innovations Shaping the Future of the Patent Ductus Arteriosus (PDA) Occlusion Devices Market 

Technological innovation remains a cornerstone of the Patent Ductus Arteriosus (PDA) Occlusion Devices Market trajectory. Recent developments focus on enhancing device efficacy and safety, such as the design of occluders that minimize the risk of embolization and thrombus formation. For example, devices featuring covered or coated surfaces are being introduced to reduce post-implant complications and improve biocompatibility. 

The trend towards personalized medicine is also influencing product development within the Patent Ductus Arteriosus (PDA) Occlusion Devices Market. Customizable occluders tailored to individual anatomical variations are becoming more prevalent, supported by advancements in 3D printing and patient-specific modeling. Such innovations contribute to higher procedural success and lower repeat intervention rates. 

Moreover, integration of smart technology for real-time device monitoring post-implantation is emerging as a value-added feature. Devices equipped with sensors that track hemodynamic changes can facilitate early detection of complications, thereby enhancing patient safety and clinical outcomes. 

 

Rising Demand for Minimally Invasive Procedures Driving the Patent Ductus Arteriosus (PDA) Occlusion Devices Market 

The shift towards minimally invasive cardiac interventions is a critical growth engine for the Patent Ductus Arteriosus (PDA) Occlusion Devices Market. Minimally invasive techniques significantly reduce hospitalization duration and procedural risks, which has increased patient acceptance and physician preference for PDA occlusion devices. 

For instance, catheter-based closure methods have surpassed surgical ligation in many healthcare settings due to lower morbidity and faster recovery. Data indicates that transcatheter PDA closure accounts for over 70% of interventions in developed countries, highlighting the growing reliance on these devices. 

This demand is further stimulated by increasing availability of pediatric cardiology expertise and the establishment of specialized centers capable of performing these delicate interventions. The consequent rise in procedural volumes is expanding the Patent Ductus Arteriosus (PDA) Occlusion Devices Market size, with projections suggesting a compound annual growth rate (CAGR) exceeding 6% over the next five years. 

 

Expanding Application Areas Catalyzing Growth in the Patent Ductus Arteriosus (PDA) Occlusion Devices Market 

Beyond neonatal and pediatric applications, the Patent Ductus Arteriosus (PDA) Occlusion Devices Market is witnessing expanded utilization in adult patient populations. For example, adults with late-diagnosed PDA or complications such as pulmonary hypertension are increasingly candidates for device-based closure. 

Emerging clinical evidence supports the efficacy of PDA occlusion devices in managing these complex cases, further broadening the market scope. Additionally, the devices are being explored for off-label uses, such as occluding other vascular anomalies, thereby diversifying revenue streams and stimulating innovation. 

The increase in diagnostic rates through improved screening programs also underlines the growing patient pool, contributing to an expanding market size. For instance, neonatal screening programs in developed countries have increased early detection rates by 15–20% annually, directly influencing device demand. 

 

Competitive Landscape and Strategic Developments in the Patent Ductus Arteriosus (PDA) Occlusion Devices Market 

Competition in the Patent Ductus Arteriosus (PDA) Occlusion Devices Market is intensifying, driven by product innovation and strategic partnerships. Leading manufacturers are investing heavily in research and development to introduce next-generation devices that address unmet clinical needs, such as reducing device size for extremely low birth weight infants. 

For example, collaborations between device makers and research institutions have resulted in novel delivery systems that enhance procedural precision. Licensing agreements and mergers are also common strategies aimed at expanding product portfolios and geographic reach, reinforcing market positions. 

Moreover, the focus on regulatory approvals and clinical trial data substantiating device safety and efficacy is critical in differentiating products within the Patent Ductus Arteriosus (PDA) Occlusion Devices Market. This environment fosters continuous innovation and competitive pricing strategies, ultimately benefiting healthcare providers and patients. 

 

Economic Factors and Reimbursement Policies Influencing the Patent Ductus Arteriosus (PDA) Occlusion Devices Market 

Economic considerations and reimbursement frameworks significantly impact the Patent Ductus Arteriosus (PDA) Occlusion Devices Market dynamics. In regions where public and private insurers provide robust coverage for transcatheter PDA closure, adoption rates are markedly higher. For example, reimbursement policies in the United States and Europe support device-based interventions, facilitating broader clinical use. 

Conversely, in low- and middle-income countries, limited healthcare funding and reimbursement challenges constrain market growth. However, increasing government initiatives aimed at improving congenital heart disease management are gradually enhancing access to PDA occlusion devices in these markets. 

Price sensitivity among healthcare providers also influences purchasing decisions within the Patent Ductus Arteriosus (PDA) Occlusion Devices Market, prompting manufacturers to optimize cost structures and offer tiered product options to meet diverse budget requirements. 

 

Future Outlook and Growth Projections for the Patent Ductus Arteriosus (PDA) Occlusion Devices Market 

Looking forward, the Patent Ductus Arteriosus (PDA) Occlusion Devices Market is projected to sustain robust growth fueled by ongoing innovation, expanding patient populations, and rising procedural adoption. Datavagyanik projects that the market size will experience steady CAGR expansion, supported by continuous improvements in device safety and efficacy. 

Emerging trends such as telemedicine integration and remote patient monitoring are expected to complement device use by enabling enhanced post-procedure care and follow-up, further driving market demand. 

 

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Geographical Demand Patterns in the Patent Ductus Arteriosus (PDA) Occlusion Devices Market 

The geographical demand landscape of the Patent Ductus Arteriosus (PDA) Occlusion Devices Market is characterized by pronounced disparities driven by healthcare infrastructure, population demographics, and economic development. For example, North America continues to dominate the market owing to advanced healthcare systems, high awareness levels, and widespread adoption of minimally invasive cardiology procedures. The United States, in particular, holds a substantial share due to the prevalence of congenital heart defects and accessibility to cutting-edge PDA occlusion devices. 

In contrast, the Asia-Pacific region is emerging as a pivotal growth hotspot within the Patent Ductus Arteriosus (PDA) Occlusion Devices Market. Rapid improvements in healthcare delivery, rising birth rates, and increasing government investments in pediatric cardiology are propelling demand. For instance, countries such as India and China report a high incidence of congenital heart diseases, with India accounting for approximately 1.5 million children born annually with some form of heart defect, a significant portion of which includes PDA cases. This volume underlines the expanding need for efficient occlusion devices in these populous regions. 

Europe remains a steady contributor to the Patent Ductus Arteriosus (PDA) Occlusion Devices Market, supported by well-established medical reimbursement policies and sophisticated cardiac care units. Countries like Germany and the United Kingdom exhibit consistent demand driven by early screening programs and growing preference for non-surgical PDA closure. 

 

Influence of Healthcare Infrastructure on Patent Ductus Arteriosus (PDA) Occlusion Devices Market Expansion 

Healthcare infrastructure fundamentally shapes the Patent Ductus Arteriosus (PDA) Occlusion Devices Market across various regions. For example, in North America and Europe, extensive networks of specialized cardiac centers facilitate early diagnosis and intervention, leading to increased utilization of PDA occlusion devices. The availability of skilled interventional cardiologists and advanced imaging technology supports procedural success and propels market growth. 

Conversely, in regions like Latin America and parts of the Middle East and Africa, limited access to specialized pediatric cardiology care restricts the immediate adoption of these devices. However, strategic investments in healthcare infrastructure, exemplified by the establishment of dedicated cardiac units and training programs, are gradually opening new avenues for the Patent Ductus Arteriosus (PDA) Occlusion Devices Market in these territories. 

 

Advancements in Patent Ductus Arteriosus (PDA) Occlusion Devices Manufacturing Driving Market Innovation 

Innovation within Patent Ductus Arteriosus (PDA) Occlusion Devices Manufacturing is a key catalyst propelling market evolution. Manufacturers are focusing on enhancing device design, incorporating materials such as bioresorbable polymers and shape-memory alloys to improve patient compatibility and procedural outcomes. For example, the integration of nitinol frameworks offers superior flexibility and conformability, reducing the risk of device migration post-implantation. 

Moreover, the Patent Ductus Arteriosus (PDA) Occlusion Devices Manufacturing process is increasingly leveraging automated production techniques and stringent quality control standards to ensure consistency and safety. Facilities utilizing state-of-the-art cleanroom environments and precision engineering are able to produce smaller, more efficient devices tailored for use in extremely premature infants, expanding the patient base. 

Investment in research and development within Patent Ductus Arteriosus (PDA) Occlusion Devices Manufacturing is also driving the creation of next-generation delivery systems. These systems facilitate smoother navigation through complex vascular pathways, minimizing procedural time and complications. 

 

Market Segmentation Insights within the Patent Ductus Arteriosus (PDA) Occlusion Devices Market 

A detailed examination of the Patent Ductus Arteriosus (PDA) Occlusion Devices Market segmentation reveals diverse application areas and product categories influencing market dynamics. Product segmentation generally includes coil devices, occluder devices, and surgical ligation alternatives, with coil and occluder devices commanding a larger market share due to their minimally invasive nature. 

For example, coil occlusion devices are often preferred for small to moderate PDA defects due to ease of deployment and cost-effectiveness, accounting for approximately 40% of the market share. Meanwhile, occluder devices, which offer enhanced sealing for larger defects, constitute a significant segment and are witnessing growing demand, particularly in developed markets where procedural expertise is high. 

End-user segmentation includes hospitals, specialized cardiac clinics, and ambulatory surgical centers. Hospitals continue to dominate the Patent Ductus Arteriosus (PDA) Occlusion Devices Market, given their comprehensive care capabilities and ability to handle complex cases. However, the rise of specialized outpatient centers capable of performing catheter-based interventions is shifting some market share toward these settings, reflecting changing healthcare delivery models. 

 

Price Trends Impacting the Patent Ductus Arteriosus (PDA) Occlusion Devices Market 

Price trends within the Patent Ductus Arteriosus (PDA) Occlusion Devices Market are influenced by several factors, including manufacturing costs, technological complexity, and regional economic conditions. For instance, high-end occluder devices embedded with advanced materials and delivery mechanisms command premium pricing, especially in developed markets where reimbursement supports adoption. 

At the same time, cost optimization in Patent Ductus Arteriosus (PDA) Occlusion Devices Manufacturing is enabling the production of more affordable alternatives tailored for emerging economies. This strategy is crucial for market penetration in price-sensitive regions such as Asia-Pacific and Latin America, where demand growth is robust but purchasing power varies widely. 

For example, the average price for a PDA occlusion device in North America ranges between $3,000 and $5,000, whereas in certain Asian countries, lower-cost variants priced closer to $1,000 are gaining traction without compromising safety or efficacy. This price differentiation is contributing to an expanding global market, as more healthcare providers can integrate these devices into treatment protocols. 

 

Role of Regulatory Frameworks on Patent Ductus Arteriosus (PDA) Occlusion Devices Market Dynamics 

Regulatory environments significantly shape the Patent Ductus Arteriosus (PDA) Occlusion Devices Market by dictating approval timelines, safety standards, and clinical trial requirements. For instance, the United States Food and Drug Administration (FDA) and European Medicines Agency (EMA) impose rigorous scrutiny, ensuring that devices meet high efficacy and safety benchmarks before market entry. 

Such regulations promote innovation by encouraging manufacturers to invest in comprehensive clinical validation and post-market surveillance. This process boosts clinician confidence in the devices and drives adoption within the Patent Ductus Arteriosus (PDA) Occlusion Devices Market. 

Emerging markets are gradually aligning their regulatory frameworks with international standards, facilitating faster approval of novel devices. This alignment is enabling more rapid diffusion of innovative occlusion technologies into these regions, thereby expanding the Patent Ductus Arteriosus (PDA) Occlusion Devices Market footprint. 

 

Impact of Patent Ductus Arteriosus (PDA) Occlusion Devices Manufacturing on Market Accessibility 

The efficiency and scalability of Patent Ductus Arteriosus (PDA) Occlusion Devices Manufacturing directly influence device availability and market penetration. Large-scale manufacturing facilities equipped with advanced automation and quality assurance systems can produce higher volumes at lower costs, making devices more accessible globally. 

For example, manufacturers leveraging lean production methodologies are reducing lead times and enhancing supply chain responsiveness. This agility is crucial in addressing fluctuating demand, especially during periods of increased congenital heart disease diagnosis or regional outbreaks that impact healthcare priorities. 

Additionally, regional manufacturing hubs established closer to emerging markets reduce logistics costs and tariffs, facilitating competitive pricing in these territories. Such strategic localization within Patent Ductus Arteriosus (PDA) Occlusion Devices Manufacturing is instrumental in broadening market reach and supporting growth in underserved regions. 

 

Emerging Technologies and Their Influence on Patent Ductus Arteriosus (PDA) Occlusion Devices Manufacturing 

The integration of emerging technologies such as additive manufacturing (3D printing), artificial intelligence (AI), and advanced materials science is transforming Patent Ductus Arteriosus (PDA) Occlusion Devices Manufacturing. For instance, 3D printing allows rapid prototyping and customization, enabling manufacturers to develop patient-specific devices that enhance procedural success rates. 

AI-driven design tools optimize device geometry for improved hemodynamic performance and reduced complication risk. Additionally, new biocompatible materials developed through nanotechnology provide enhanced durability and reduced inflammatory response post-implantation. 

These technological advancements not only improve device quality but also reduce manufacturing costs over time, driving competitive advantages within the Patent Ductus Arteriosus (PDA) Occlusion Devices Market. 

 

Distribution Channels and Their Role in Patent Ductus Arteriosus (PDA) Occlusion Devices Market Expansion 

Distribution networks play a critical role in shaping the accessibility of PDA occlusion devices worldwide. Established partnerships between manufacturers, medical device distributors, and healthcare providers streamline product availability, ensuring timely delivery to critical care units. 

For example, in developed markets, direct sales and hospital contracts dominate, supported by comprehensive training programs for clinicians. In contrast, emerging markets rely more heavily on distributor networks that understand local regulatory landscapes and can navigate logistical complexities. 

Enhancing these distribution channels, such as through e-commerce platforms and digital supply chain management, is expected to accelerate the Patent Ductus Arteriosus (PDA) Occlusion Devices Market growth by reducing delays and expanding geographic reach. 

 

Consumer Awareness and Training Programs Driving Patent Ductus Arteriosus (PDA) Occlusion Devices Market Adoption 

Increasing awareness among clinicians and patients about the benefits of PDA occlusion devices significantly impacts market demand. For example, targeted training programs for cardiologists on the latest device technologies and procedural techniques improve adoption rates and patient outcomes. 

Hospital initiatives aimed at educating families about minimally invasive treatment options for PDA contribute to higher acceptance and demand. These educational efforts are especially influential in regions where surgical interventions have traditionally been the default treatment. 

As a result, continuous professional development and public awareness campaigns are vital components in expanding the Patent Ductus Arteriosus (PDA) Occlusion Devices Market. 

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Key Manufacturers in the Patent Ductus Arteriosus (PDA) Occlusion Devices Market 

The Patent Ductus Arteriosus (PDA) Occlusion Devices Market is dominated by several prominent manufacturers whose innovative product lines and global reach have helped define market dynamics. Among these, Abbott Laboratories stands out as a market leader, largely driven by its Amplatzer™ family of occlusion devices. The Amplatzer™ Duct Occluder II is widely regarded for its ease of deployment, reliability, and ability to effectively close PDAs in a broad range of patient anatomies. Its design allows for minimally invasive transcatheter procedures, which has bolstered its widespread adoption in both pediatric and adult cardiology. 

Another major player is Lepu Medical Technology, which has gained significant traction in Asia and emerging markets through its MemoPart™ PDA Occluder. This device is recognized for its self-expanding nitinol mesh structure and biocompatible design, which contribute to reduced procedural risks and faster patient recovery. Lepu’s competitive pricing strategy and expanding manufacturing capabilities have strengthened its foothold in price-sensitive regions, fueling rapid growth.

Braun Interventional Systems commands a respectable share of the Patent Ductus Arteriosus (PDA) Occlusion Devices Market with its Nit-Occlud® PDA coil system. This coil-based occlusion technology remains preferred for treating smaller PDAs due to its minimally invasive nature and cost-effectiveness. The Nit-Occlud® coils are favored in European markets and increasingly adopted in select emerging regions, supported by consistent product improvements and clinician training programs.

Occlutech, with a reputation for product innovation, continues to expand its portfolio of PDA occlusion devices, emphasizing customizable solutions and biocompatibility enhancements. Their offerings cater to diverse clinical needs and have been particularly well received in Europe and parts of Asia. 

MicroPort Scientific Corporation is also a significant contributor, focusing on developing advanced cardiovascular devices for the Patent Ductus Arteriosus (PDA) Occlusion Devices Market. Their efforts in research and development have resulted in a range of effective devices designed for ease of implantation and superior closure rates, enabling expansion into new geographic markets. 

 

Market Share Distribution in the Patent Ductus Arteriosus (PDA) Occlusion Devices Market 

Market share in the Patent Ductus Arteriosus (PDA) Occlusion Devices Market reflects a combination of product efficacy, geographic reach, regulatory approvals, and pricing strategies. Abbott Laboratories maintains the largest market share globally, credited to its early entry, extensive clinical validation, and wide-ranging product availability. The Amplatzer™ devices alone account for a significant portion of transcatheter PDA closure procedures worldwide, supported by strong physician familiarity and robust customer support. 

Lepu Medical Technology’s share is growing rapidly, particularly across Asia-Pacific regions. Their emphasis on cost-effective yet high-quality occluders has resonated well in countries where healthcare budgets are limited but the prevalence of PDA is high. This regional strength has allowed Lepu to capture notable portions of the Patent Ductus Arteriosus (PDA) Occlusion Devices Market in emerging economies.

Braun Interventional Systems holds a solid market presence, especially in Europe and parts of Latin America. Its focus on coil devices, which serve a different segment of the PDA treatment spectrum, allows it to complement rather than compete directly with occluder manufacturers, capturing niche market segments effectively.

Occlutech’s innovative product line has enabled it to carve out a meaningful share, particularly in markets that value customization and advanced material technologies. Its strategic partnerships with distributors and healthcare providers in Europe and Asia have further enhanced its market penetration. 

MicroPort Scientific Corporation has steadily increased its share by leveraging strong research capabilities and expanding sales operations. Its ability to develop devices suited for local clinical needs has helped it establish footholds in competitive markets across Asia and beyond. 

 

Recent Industry Developments in the Patent Ductus Arteriosus (PDA) Occlusion Devices Market 

The Patent Ductus Arteriosus (PDA) Occlusion Devices Market continues to evolve through significant technological advancements and regulatory milestones. A major recent breakthrough was the approval of a new generation of PDA occluders designed specifically for premature infants and very low birth weight neonates. These devices offer reduced profiles and enhanced flexibility, allowing for safer deployment in delicate patient populations, thereby addressing a critical unmet clinical need. 

Abbott Laboratories recently introduced an updated version of its Amplatzer™ Piccolo Occluder, which further refines delivery techniques and reduces procedure times. This development has reinforced Abbott’s leadership position and expanded its influence in neonatal cardiology. 

Lepu Medical Technology has simultaneously accelerated product enhancements to its MemoPart™ PDA Occluder, focusing on material biocompatibility and long-term closure success. These improvements have translated into increased adoption across Asian markets and growing interest from healthcare providers seeking affordable yet high-quality solutions.

Braun Interventional Systems has invested in optimizing its Nit-Occlud® coil system, enhancing its coil configuration and delivery mechanisms to improve procedural safety. Additionally, B. Braun has expanded training initiatives worldwide, supporting clinicians in adopting best practices for PDA closure.

Occlutech has broadened its portfolio with new customizable devices, expanding its reach through collaborations with regional distributors. The company also recently announced plans to accelerate its production capacity, responding to increasing demand across multiple geographies. 

MicroPort Scientific Corporation is advancing research collaborations aimed at integrating smart technologies with PDA occlusion devices, such as remote monitoring capabilities that can improve post-procedural patient management. Such initiatives indicate a growing trend towards connected medical devices within this market segment. 

 

Summary of Market Movements and Industry Timelines 

• Early 2024: Abbott Laboratories launched the latest iteration of the Amplatzer™ Piccolo Occluder, reinforcing its market leadership in neonatal PDA treatment. 

• Mid-2024: Lepu Medical Technology expanded its manufacturing facilities to meet surging demand in the Asia-Pacific region, focusing on the MemoPart™ PDA Occluder. 

• Q3 2024: B. Braun Interventional Systems enhanced its Nit-Occlud® PDA coil delivery system, resulting in improved ease of use and expanded clinical adoption. 

• Late 2024: Occlutech secured new distribution agreements in key European and Asian markets, facilitating wider availability of its PDA occlusion devices. 

• Early 2025: MicroPort Scientific Corporation announced research partnerships exploring AI integration in PDA occlusion device monitoring, signaling future market innovation trends. 

 

“Patent Ductus Arteriosus (PDA) Occlusion Devices Production Data and Patent Ductus Arteriosus (PDA) Occlusion Devices Production Trend”

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