Summary

Overview
Global Congenital Heart Defect Devices Market reached US$ 2.8 billion in 2022 and is expected to reach US$ 4.6 billion by 2030, growing with a CAGR of 6.4% during the forecast period 2023-2030.
The global congenital heart defect devices market has witnessed significant growth and transformations over the years, with various factors influencing its dynamics such as the increasing prevalence of congenital heart defects from birth, rising clinical trials and research activities, and others. Government investments in better device manufacturing will continue to drive and boost the global market. The global congenital heart defect devices industry is placing increasing emphasis on reducing its impact.
Congenital heart defect devices such as artificial pacemakers, implantable cardioverter defibrillators, catheters, and others are most commonly used to treat congenital heart defects such as bradycardia, tachycardia, and others. Catheters segment is expected to hold the largest market share over the forecast period. Similarly, North America dominates the market, capturing the largest market share owing to the region’s favorable reimbursement policies, advanced healthcare infrastructure, and presence of major players.
Owing to the increasing prevalence of congenital heart defects, increasing demand for advanced devices, growing awareness, rising clinical trials, increasing adoption of minimally invasive procedures, and technological advancements are the major factors expected to drive the global market over the forecast period.
Dynamics
Increasing Adoption of Minimally Invasive Procedures is Expected to Drive the Growth of the Congenital Heart Defect Devices Market
The increasing adoption of minimally invasive procedures is expected to drive the growth of the market over the forecast period. Congenital heart defect devices such as catheters, cardiac occluders, and other devices offers minimally invasive procedures to treat patients in a better way. Many patients with congenital heart defects mostly prefer minimally invasive procedures over traditional open-heart surgeries due to their benefits like shorter reduced pain, quicker recovery times, and smaller scars. This preference is especially strong for pediatric patients with congenital heart defects.
For instance, on February 22, 2023, Medtronic announced the relaunch of its Harmony Transcatheter Pulmonary Valve (TPV) System, a minimally invasive alternative to open-heart surgery for congenital heart disease patients with native or surgically repaired right ventricular outflow tract (RVOT).
Moreover, minimally invasive procedures are expected to have complications such as infections, bleeding, and wound healing issues. This can improve patient safety and reduce further complications. These minimally invasive procedures offers enhanced benefits, especially for pediatric patients to treat many congenital heart defects in safe way.
For instance, on June 15, 2021, Abbott, the global healthcare company, launched its Amplatzer Piccolo Occluder in India, the world's first medical device that can be implanted in the tiniest babies (weighing as little as 700 gms) using a minimally invasive procedure to treat patent ductus arteriosus (a congenital heart defect) or PDA. The Amplatzer Piccolo, a device even smaller than a small pea, now offers hope to premature infants and newborns who need corrective treatment, and who may be non-responsive to medicine and are at high risk to undergo corrective surgery.
Increasing Clinical Trials is Also Expected to Drive the Growth of the Congenital Heart Defect Devices Market
The increasing clinical trials for advanced congenital heart defect devices are also expected to drive the growth of the market over the forecast period. Clinical trials provide a platform to test and validate the safety and efficacy of emerging devices designed for the treatment of congenital heart defects. Positive trial outcomes can lead to regulatory approvals and market introductions, driving growth.
For instance, on July 08, 2021, Xeltis announced that it had started the first-ever pivotal trial for a synthetic restorative pulmonary valve. To date, pediatric patients requiring right ventricular outflow tract (RVOT) reconstruction have been successfully implanted as part of the global, FDA-approved Xplore2/Pivotal study. RVOT reconstruction is a procedure needed to correct certain congenital heart defects.
Further, the clinical trials also generate scientific evidence regarding the performance of congenital heart defect devices. This evidence is crucial for healthcare providers when making treatment decisions, which can lead to increased adoption of these devices. Clinical trials also aim to improve patient outcomes by assessing the safety and efficacy of devices. Positive results can lead to better treatment options, attracting more patients to seek these better treatment by using these devices.
Complications Associated with the Devices is Expected to Hamper the Market's Growth
The complications associated with congenital heart defect devices are expected to hamper the growth of the market. Malfunctions or technical failures associated with the devices used in CHD, such as catheters, pacemakers, stents, valves, or occluders, can pose serious risks. Device failure may require additional interventions or surgeries to correct, which can lead to increased healthcare costs and other risks that leads to patient dissatisfaction.
Additionally, any invasive procedure like catheter-based interventions is expected to carry a risk of infection in aducts, and decreased oxygen levels, and irregular heart rhythms in children. Infections can occur at the insertion site or, in some cases, within the heart itself further leading to serious complications. Infection can prolong hospital stays, necessitate antibiotic treatments, and potentially lead to sepsis, a life-threatening condition.
Segment Analysis
The global congenital heart defect devices market is segmented based on defect type, device type, end-user, and region.
The Catheters Segment Accounted for Approximately 29.4% of the Congenital Heart Defect Devices Market Share
The catheters segment is expected to hold the largest market share over the forecast period. There are continuous advancements in catheters, including the development of smaller, more flexible catheters and improved imaging techniques, which have expanded the range of congenital heart defects that can be treated using these catheters. These advancements in catheters provide more efficient results within short time.
For instance, on September 8, 2022, Biosense Webster, Inc., part of Johnson & Johnson MedTech, announced the release of the OCTARAY Mapping Catheter with TRUEref Technology powered by the CARTO 3 Version 7 System. The OCTARAY Mapping Catheter was developed for the mapping of cardiac arrhythmias, including atrial fibrillation (AFib). The catheter has eight splines with improved electrode spacing options to provide shorter and more efficient mapping times than PENTARAY NAV ECO Mapping Catheter, which may shorten overall ablation procedure times.
Furthermore, these catheter-based procedures offers minimally invasive procedures compared to other devices. This less invasive approach of catheters reduces trauma, shortens recovery times, and minimizes the risk of complications associated with congenital heart defects. This is especially important for pediatric patients suffering from congenital heart defects. Catheter procedures generally carry fewer surgical risks than other devices. There is no need for a sternotomy (chest incision), which can lead to complications like infection or scarring.
For instance, on February 2, 2023, Abbott announced two approvals as part of its growing suite of electrophysiology products in the global market. The company’s TactiFlex Ablation Catheter, Sensor Enabled, the world’s only ablation catheter with a flexible tip and contact force sensing, received CE Mark for treating people with abnormal heart rhythms like atrial fibrillation (AFib). Abbott’s FlexAbility Ablation Catheter, Sensor Enabled also recently secured an expanded indication for treating patients with a complex heart condition by the U.S. Food and Drug Administration.
Geographical Penetration
North America Accounted for Approximately 39.7% of the Market Share in 2022, Owing to the Strong Presence of Major Players and Advanced Healthcare Infrastructure
North America region is expected to hold the largest market share over the forecast period owing to the strong presence of major players and advanced healthcare infrastructure. North America is well-known for the strong presence of major players in the region including many pharmaceutical companies and medical device companies. The presence of major players in the region helps to perform the clinical trials and research activities very actively, which helps for the development of advanced devices for congenital heart defects.
Moreover, the region is also very well-known for its advanced and well-established healthcare infrastructure including hospitals, specialty clinics, research and academic centers, and others. This advanced healthcare infrastructure helps patients seek better treatment by choosing advanced and well-suitable devices. Many hospitals in the region is very well-known for their better implantation techniques.
For instance, on May 18, 2022, Children's Hospital Colorado (Children's Colorado) was the first hospital in the world to implant the newly FDA-approved G-Armor Stent. Although the stent is designed to be used in the smallest of patients, it was first implanted in a Colorado father of two. The stent was developed by interventional cardiologist, Gareth Morgan, MD, who oversees the Interventional Congenital Cardiology program at Children's Colorado in conjunction with NuMed for Children.
Competitive Landscape
The major global players in the congenital heart defect devices market include Lepu Medical Technology Co., Ltd., Abbott Laboratories, Becton, Dickinson and Company, Medtronic, Boston Scientific Corporation, Biotronik, Edwards Lifesciences Corporation., OSYPKA MEDICAL, ABIOMED., and MEDICO S.R.L. among others.
COVID-19 Impact Analysis
The outbreak of the COVID-19 pandemic in late 2019 created unprecedented challenges for pharmaceutical industries worldwide, including the global congenital heart defect devices market. During the pandemic, many clinical trials, research activities, and regulatory approvals have been temporarily postponed due to the redirected focus on the COVID-19 pandemic treatment and its related restrictions.
The onset of the pandemic in early 2020 led to widespread lockdowns and restrictions, impacting regular check-ups, appointments, device implantations, and consultations worldwide. Many hospitals are focused on COVID-19 cases, this reduced the device implantation in many patients suffering from congenital heart defects.
Moreover, the COVID-19 pandemic severely disrupted global supply chains, impacting the transportation of raw materials and medical devices. Movement restrictions and border closures delayed shipments and caused device transportation delays. Additionally, some countries faced shortages of congenital heart defect devices for treatment due to disruptions in their supply chain networks.
Russia-Ukraine Conflict Analysis
The Russia-Ukraine conflict is estimated to have a moderate impact on the global congenital heart defect devices market. The conflict has less impact mainly due to the low prevalence and absence of key market players in this region. Moreover, the impact of the import and export of raw materials and medical devices is expected to have little influence over the global congenital heart defect devices market growth over the forecast period.
By Defect Type
• Atrial Septal Defect
• Ventricular Septal Defect
• Atrioventricular Septal Defect
• Tricuspid Atresia
• Truncus Arteriosus
• Others
By Device Type
• Catheters
• Pacemakers
o Single Chamber Pacemaker
o Dual Chamber Pacemaker
o Biventricular Pacemaker
o Leadless Pacemaker
• Implantable Cardioverter Defibrillators
• Biventricular Devices
• Implanted Cardiac Loop Recorders
• Others
By End-User
• Hospitals
• Specialty Clinics
• Academic and Research Institutes
• Others
By Region
• North America
o U.S.
o Canada
o Mexico
• Europe
o Germany
o U.K.
o France
o Spain
o Italy
o Rest of Europe
• South America
o Brazil
o Argentina
o Rest of South America
• Asia-Pacific
o China
o India
o Japan
o Australia
o Rest of Asia-Pacific
• Middle East and Africa
Key Developments
• On May 31, 2023, BrightHeart, a Paris-based medical technology company developing unique artificial intelligence software focused on improving the detection of congenital heart defects in fetuses, announced that it has raised €2 million in seed financing from Sofinnova Partners, a leading European life sciences venture capital firm based in Paris, London, and Milan. The funds are being deployed to bolster the development of the BrightHeart technology devices, prepare its regulatory submission, and facilitate the company's expansion.
• On February 28, 2023, Eko, a digital health company applying artificial intelligence (AI) in the fight against heart and lung disease, announced the launch of the SENSORA Cardiac Disease Detection Platform. SENSORA currently features AI that objectively identifies structural murmurs, a sign of valvular heart disease, and Care Pathway Analytics software that provides downstream visibility and metrics of the patient journey through the healthcare system.
• On September 07, 2022, Abbott announced that it launched its Amplatzer Talisman patent foramen ovale (PFO) occlusion system in Europe. PFO is a hole in the heart that doesn’t close following birth. The company designed the Amplatzer Talisman to treat people with PFO who experienced a stroke and are at risk of having another.
• On March 26, 2021, the U.S. Food and Drug Administration (FDA) approved the Harmony Transcatheter Pulmonary Valve (TPV) as the world's first nonsurgical heart valve to treat pediatric and adult patients with a native or surgically-repaired right ventricular outflow tract (RVOT). The device is designed for patients who have severe pulmonary valve regurgitation and is intended to both delay and reduce the number of required lifetime open-heart surgeries by improving blood flow to the lungs.
Why Purchase the Report?
• To visualize the global congenital heart defect devices market segmentation based on defect type, device type, 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 congenital heart defect devices 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 congenital heart defect devices market report would provide approximately 61 tables, 58 figures, and 186 Pages.
Target Audience 2023
• Manufacturers/ Buyers
• Industry Investors/Investment Bankers
• Research Professionals
• Emerging Companies

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