Atrial Septal Occluder Devices Market Size, Share, Industry, Forecast and outlook (2023-2030)
Atrial Septal Occluder Devices Market is segmented By Product Type (Atrial Septal Defect Device, Ventricular Septal Defect Device), By End User (Hospitals and Ambulatory Surgical Centers, Specialty Clinics, Others), By Region (North America, Latin America, Europe, Asia Pacific, Middle East, and Africa) – Share, Size, Outlook, and Opportunity Analysis, 2023-2030.
The Atrial Septal Occluder Devices Market is estimated to reach at a high CAGR during the forecast period 2023-2030.
Atrial septal occlusion devices are implantable cardiac devices used in patients with certain types of atrial septal defects. 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.
Atrial Septal Occluder Devices Market - Strategic Insights
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Metrics |
Details |
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Market CAGR |
Atrial Septal Occluder Devices Market is estimated to reach at a high CAGR during the forecast period 2023-2030. |
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Segments Covered |
By Product Type, By End User and By Region |
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Report Insights Covered |
Competitive Landscape Analysis, Company Profile Analysis, Market Size, Share, Growth, Demand, Recent Developments, Mergers and acquisitions, New Product Launches, Growth Strategies, Revenue Analysis, and Other key insights. |
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Fastest Growing Region |
Asia Pacific |
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Largest Market Share |
North America |
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Market Dynamics
An increase in the prevalence of stroke and technological advancements will drive the Atrial Septal Occluder Devices Market in the forecast period.
Increase in the prevalence of stroke will drive the Atrial Septal Occluder Devices Market
Stroke is the second leading cause of death worldwide and the main cause of long-term neurological disability in adults.
Every year, in the U.S more than 795,000 people have a stroke. About 610,000 of these are first or new strokes. Approximately 185,000 strokes—nearly 1 of 4—are in people who have had a previous stroke. About 87% of strokes are ischemic strokes, in which blood flow to the brain is blocked. Atrial septal defect or patent foramen ovale (PFO), a septal occluder device might be a good option for the people who experienced a stroke. This device may decrease the risk of stroke and allow one to stop taking blood thinners.
PFO closure along with GORE® CARDIOFORM Septal Occluder offers an advanced solution for stroke teams and their cryptogenic stroke patients. The approach to stroke prevention is proven in the Gore REDUCE Clinical Study, the only U.S. IDE trial that achieved its primary end point and showed the largest reduction in recurrent ischemic stroke in all PFO shunt sizes over medical therapy alone.
Technological advancements will drive the Atrial Septal Occluder Devices Market in the forecast period
Transcatheter closure of secundum atrial septal defect (ASD), patent foramen ovale (PFO) are now widely accepted as an alternate to surgical closure. With the availability of devices and techniques, approximately 80-90% of secundum ASDs and all PFOs can be closed percutaneously. Eventhough 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.
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.
The complications associated with the atrial septal occluder devices will hamper the market
Atrial septal defect (ASD) is the most typical surgery performed by a cardiac surgeon in training to learn the basics of cardiopulmonary bypass. Of late, this entity is slowly slipping out of the surgeon's hands because of the percutaneous devices. ASD device closure carries a not negligible burden of complications, namely atrial fibrillation, haematoma at the puncture site, device embolization, device-related erosion, and device thrombosis.
The complications reported include cardiac perforations, device malposition or embolisation, residual shunts, vascular trauma, thrombus formation, atrioventricular valve regurgitation, atrial arrhythmias, infectious endocarditis, and sudden death. Atrial septal defect closure-related complications rarely occur many years after implantation. However, the long-term risk is not negligible, and the clinician should never drop his guard down, even in asymptomatic patients. Moreover, when dealing with deficient aortic rim, weight possible risk and benefits associated with the percutaneous technique compared to the surgical intervention.
Atrial Septal Occluder Devices Market Industry Analysis
COVID-19 Impact Analysis
During the coronavirus pandemic, the LAA closure devices industry is likely to experience a surge in the growth rate. During pandemic,the governments of various countries 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 the market growth in 2020. Besides, several manufacturers are stressing their product improvements to obtain a strong position and sustain in the global market in coronavirus emergencies.
In February 2020, Abbott received an approval from the U.S. Food and Drug Administration (FDA) for their newly innovated Amplatzer Amulet Left Atrial Appendage Occluder designed for A.F. patients.
Segment Analysis
Atrial septal defect devices dominated the market
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 its occluder device was approved by the FDA for percutaneous closure of ostium secundum atrial septal defects.
On June 4, 2019 W. L. Gore & Associates (Gore) announced the premarket approval (PMA) of the GORE® CARDIOFORM ASD Occluder for the percutaneous closure of ostium secundum atrial septal defects (ASDs) from the U.S. Food and Drug Administration's (FDA's) . The approval from FDA was supported by data collected from the pivotal stage of the Gore ASSURED Clinical Study, which demonstrated 100 percent closure success at the six-month evaluation in patients with a successful implant.
Hospitals and Ambulatory Surgical Centers and ambulatory surgical centers will dominate the market
Patients who have or had repair of an atrial septal defect generally have a normal life. Most women can have normal, uncomplicated pregnancies. While small percentage of patients may develop pulmonary hypertension — high pressures in the lung circulation — or abnormal heart rhythms. For this reason, it is recommended that a cardiologist with interest in congenital heart disease evaluate all patients at least once during adulthood. A woman contemplating pregnancy also should be considered before conception. After that, yearly follow-up is prudent. Hence, hospitals and ambulatory surgical centers will dominate the market.
Geographical Analysis
North America will dominate the Atrial Septal Occluder Devices Market
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. 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.
Stroke was a leading cause of death in theU.S, killing more than 147,000 Americans in 2018.
Competitive Landscape
Some prominent key players in this market are Abbott Laboratories, Medtronic Plc., Endologix Inc., LivaNova Plc., CryoLife Inc., Cook Group Incorporated, Edwards Lifesciences Corporation, W. L. Gore & Associates, Inc., lepu medical technology and CeraFlex
Key Companies to Watch
W. L. Gore & Associates, Inc.
W. L. Gore & Associates is a global materials science company which is dedicated to transform industries and improve lives. Since 1958, Gore has solved many complex technical challenges in demanding environments from outer space to the world’s highest peaks to the human body's inner workings. It is an American multinational manufacturing company specializing in products derived from fluoropolymers. It is a private corporation headquartered in Newark, Delaware.
Product Portfolio: W. L. Gore & Associates is a company dedicated to transforming industries and improving lives. An American multinational manufacturing company specializing in products derived from fluoropolymers.
Key Development: W. L. Gore & Associates (Gore) announced the approval of the GORE HELEX Septal Occluder with a modified catheter delivery system from the U.S. Food & Drug Administration (FDA), which is indicated for the transcatheter closure of atrial septal defect (ASD). ASD is a congenital heart defect that affects thousands of patients every year. The GORE HELEX Septal Occluder is a permanent implanted prosthesis and the first device of its kind to use ePTFE, a biocompatible material which allows tissue ingrowth to seal the defect. In addition, the catheter-based delivery system which was recently approved allows easier device deployment via standard femoral venous access, bringing the GORE HELEX Septal Occluder to the forefront of non-surgical ASD repair.
The Atrial Septal Occluder Devices Market report would provide an access to an approx. 52 market data table, 40 figures and 200 pages.