Market Overview
The Global Atrial Septal Occluder Devices 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.
Atrial septal occlusion devices are implantable cardiac devices used in patients with certain types of atrial septal defects. An atrial septal defect (ASD) closure device plugs an opening in the wall that separates the left and right upper chambers of your heart (atria) called the interatrial septum.
They are used in atrial septal defects with right atrial or ventricle enlargement to prevent paradoxical embolism, left-to-right shunting, and platypnea-orthodeoxia syndrome.
An atrial septal defect, or ASD, is caused by a deficiency in the atrial septum, which causes a failure of overlap and results in a hole in the septum. Atrial septal defects (ASD) and ventricular septal defects (VSD) are best treated with occluder devices. This device creates a self-expanding nitinol mesh that blocks blood flow via the atrial hole. Heart tissue grows over the nitinol mesh over time, completely closing the defect.
Market Summary
| Metrics | Details |
| CAGR | YY% |
| Market Size | 2022-2031 |
| Market Estimation Forecast Period | 2024-2031 |
| Revenue Units | Value (US$ Mn) |
| Segments Covered | Product Type, and End-User |
| Regions Covered | North America, Europe, Asia-Pacific, South America, and Middle East & Africa |
| Largest Region | North America |
| Fastest Growing Region | Asia-Pacific |
| Report Insights Covered | Competitive Landscape Analysis, Company Profile Analysis, Market Size, Share, Growth, Demand, Recent Developments, Mergers and Acquisitions, New Launches, Growth Strategies, Revenue Analysis, Porter's Analysis, Pricing Analysis, Regulatory Analysis, Supply-Chain Analysis, and Other key Insights. |
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Market Dynamics
Drivers
Technological Advancements in the Cardiology Healthcare
The demand for the atrial septal occluder devices market is driven by multiple factors. Atrial septal defect (ASD) is one of the most common types of congenital heart diseases, of which 80% are secundum ASD.
Transcatheter device closure is the preferred treatment for secundum ASD. Transcatheter closure of secundum atrial septal defect (ASD), and patent foramen ovale (PFO) are now widely accepted as an alternative to surgical closure. With the availability of devices and techniques, approximately 80-90% of secundum ASDs and all PFOs can be closed percutaneously.
Even though many devices are available, the use of any particular device is primarily dictated by individual defect anatomy, device availability, long-term considerations, approval status (U.S. Food and Drug Administration approval versus C.E. mark), and physician preference.
Moreover, technological advancements in the healthcare system would propel the market growth. As per NCBI publication in October 2022, the ReAces device is a novel puncturable ASD occluder and appears safe and effective for the transcatheter closure of secundum ASD. The findings in swine models demonstrate that puncturing and crossing the central portion of the occluder is feasible and simple. This device may offer an advantage over conventional ASD occluders in the lifetime management of structural heart disease, enabling the atrial septal puncture after implantation.
Also, in the American Journal of Cardiology research publication in January 2024, Transcatheter closure is the first-line treatment for ostium secundum atrial septal defect (ASD). The GORE Cardioform ASD Occluder (GCA) is potentially innovative compared with other self-centering devices.
Restraints
Factors such as complications & complexity associated with the treatment procedure, product recalls, high cost of the treatment, lack of awareness among people, and limited reimbursement policies are expected to hamper the market.
Market Segmentation Analysis
The atrial septal occluder devices market is segmented based on product type, end-user, and region.
The atrial septal defeat devices segment accounted for approximately 38.5% of the atrial septal occluder devices market share
The atrial septal defeat segment is expected to hold the largest market share over the forecast period. In recent years, closure of an ASD in patients with a hemodynamically significant shunt has become the standard of care. Correction of ASDs helps to prevent the development of pulmonary hypertension, cardiac arrhythmia, and heart failure. Atrial septal defect closure has become an established therapy that is performed in increasing numbers of adult patients. W.L. Gore and Associates announced the FDA approved its occluder device for percutaneous closure of ostium secundum atrial septal defects.
Furthermore, key players in the industry strategies such as product approvals and partnerships and collaborations would propel this market. For instance, Abbott announced in August 2021 that the Amplatzer Amulet Left Atrial Appendage Occluder devices had received US DDA clearance to treat persons with atrial fibrillation (AFib) who are at risk of having an ischemic stroke.
The device offers immediate closure of the left atrial appendage (LAA) – an area where blood clots can form in people suffering from AFib – reducing their risk of stroke and immediately eliminating the need for blood-thinning medication.
Market Geographical Share
North America accounted for approximately 41.2% of the atrial septal occluder devices market share
North America region is expected to hold the largest market share over the forecast period. Due to the high incidence of stroke and advanced technology, this region will see a rise in the market. Stroke is the leading cause of disability and the fifth leading cause of death in the United States. As per CDC statistics in November 2023, each year, around 795,000 people in the United States experience new (610,000 people) or recurrent (185,000 people) strokes. In addition, epidemiologic studies indicate that 82-92% of strokes in the United States are ischemic.
In the U.S., the Amplatzer septal occluder (ASO) (AGA Medical Corporation, Plymouth, MN, USA) and HELEX septal occluder (W.L. Gore & Associates, Inc., Flagstaff, AZ, USA) are the only ASD closure devices which are approved by the U.S. Food and Drug Administration (FDA). A non-randomized trial in the U.S. using the ASO and the U.S. multi-center pivotal trial (using the HELEX septal occluder) both demonstrated transcatheter ASD closure to be equivalent to surgical ASD closure clinical efficacy and overall safety in patients with suitable anatomy. Though not approved in the U.S. for ASD closure, many other transcatheter occluders are approved for human use worldwide.
Moreover, in this region, major key player's presence, well-defined healthcare infrastructure, and new product launches and approvals drive this market. For instance, in February 2022, atHeart Medical, a medical device business dedicated to establishing a new standard of care for atrial septal defects (ASD) closure, announced that the second phase of its ASCENT ASD U.S. Investigational Device Exemption (IDE) pivotal trial has been approved.
The prospective, single-arm trial is looking at the safety and efficacy of the reSept ASD Occluder, the first occluder with a metal-free, bioresorbable frame, for treating patients with clinically significant, isolated ASDs. Primary objectives will be compared to established performance targets for previously FDA-approved transcatheter ASD occluders.
COVID-19 Impact Analysis
The COVID-19 pandemic significantly impacted the atrial septal occluder devices market. During the coronavirus pandemic, the LAA closure devices industry is likely to experience a surge in the growth rate.
During the pandemic, various countries' governments have taken initiatives to create awareness amongst people regarding the importance of left atrial appendage closure devices, which is the major factor expected to boost market growth. Besides, several manufacturers are stressing their product improvements to obtain a strong position and sustain in the global market in coronavirus emergencies.
Market Key Players
The major global players in the atrial septal occluder devices market include W. L. Gore & Associates, Inc., Abbott Laboratories, Medtronic Plc, Endologix Inc., B. Braun Interventional Systems Inc, Meril Life Sciences Pvt. Ltd, Lepu Medical Technology (Beijing)Co., Ltd, CeraFlex, EUKON S.r.l, Boston Scientific Corp among others.
Key Developments
- On January 15, 2024, Occlutech announced that the US Food and Drug Administration (FDA) has approved the Occlutech ASD Occluder and Occlutech Pistol Pusher for the treatment of atrial septal defects (ASD).
- On April 28, 2022, Abbott announced that its Amplatzer Steerable Delivery Sheath is available in the U.S. to treat people with atrial fibrillation. This device is used in conjunction with the company's Amplatzer Amulet Left Atrial Appendage Occluder.
Why Purchase the Report?
- To visualize the atrial septal occluder devices market segmentation based on product 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 atrial septal occluder devices market level with all segments.
- PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.
- Product mapping is available in excel consisting of key products of all the major players.
The atrial septal occluder devices market report would provide approximately 54 tables, 41 figures, and 181 Pages.
Target Audience 2024
- Manufacturers/ Buyers
- Industry Investors/Investment Bankers
- Research Professionals
- Emerging Companies
