Patent Foramen Ovale Closure Device Market

Market Definition

Patent foramen ovale closure device are used to close defects or an opening between the right and left sides of the heart. Patent foramen ovale (PFO) closure device is an implantable device used to treat patent foramen ovale (PFO) through a minimally invasive catheter-based technique, used in the number of pathological states including transient ischemic attacks, cryptogenic strokes, migraine with auras, severe refractory hypoxemia, and decompression sickness.

Market Dynamics

Rising incidence of ischemic stock is a key driving factor of the market. Ischemic stroke is a type of stroke. Ischemic stroke is also referred to as brain ischemia and cerebral ischemia. Ischemic stroke is caused due to blockage in an artery that supplies blood to the brain. The blockage reduces the oxygen and blood flow to the brain, which leads to damage or death of brain cells. According to the Centers for Disease Control and Prevention (CDC), each year, in the United States, more than 795,000 people suffer from stroke, of which around 87% of all strokes are ischemic strokes. According to the American Heart Association, around 40,000 infants are born with a congenital heart defect in the United States annually, and around 2 to 3 million individuals are suffering from a congenital heart defect. However, recall and discontinuation of patent foramen ovale closure device might hamper the market growth. For instance, W.L. Gore & Associates Inc. has discontinued its Helex Septal Occluder, which was used for the treatment of for patent foramen ovale closure and ASD closure. The company was sued by Boston-based NMT Medical Inc. for allegedly infringing on a patent. Moreover, rising awareness regarding patent foramen ovale (PFO) would provide lucrative opportunities for the market in the coming years.

Market Segmentation

Global patent foramen ovale closure device market is mainly classified based on type and application. Type is further segmented into Amplatzer PFO Occluder and Other PFO Occluder. By application, the market is divided into Hospitals, Clinics and Other. 

Amplatzer PFO Occluder was dominating the patent foramen ovale closure device in 2019, owing to the increasing clinical research on patent foramen ovale closure device, the partnership between companies to market patent foramen ovale closure device, commercialization of regulatory approved patent foramen ovale closure device. For instance, St. Jude Medical, Inc., a global medical device company, has received U.S. Food and Drug Administration (FDA) approval and launch of the AMPLATZER PFO Occluder to reduce the risk of recurrent ischemic strokes for patients diagnosed with patent foramen ovale (PFO), a small opening between the upper chambers of the heart. 

Regional Analysis

Based on geography, the global patent foramen ovale closure device market is divided into North America, Europe, Asia-Pacific, South America, and Middle East & Africa. North America is further divided in the U.S., Canada, and Mexico, whereas Europe consists of the UK, Germany, France, Italy, and Rest of Europe. Asia-Pacific is segmented into India, China, Japan, South Korea, and Rest of Asia-Pacific. The South America region includes Brazil, Argentina, and the Rest of South America, while the Middle East & Africa is categorized into GCC Countries, Egypt, South Africa, and Rest of Middle East & Africa.

North America was dominating the global patent foramen ovale closure device market in 2019, attributed to the high incidence of ischemic stroke in the United States, raising awareness about patent foramen ovale closure device, regulatory approval of patent foramen ovale closure device, and increasing clinical trials for new patent foramen ovale closure device. For instance, Lifetech Scientific (Shenzhen) Co., Ltd. has conducted its Post Market Clinical Follow-up study for its IrisFIT PFO Occluder for the indication of PFO. IrisFITTM PFO occluder is designed for PFO patients associated with recurrent Transient Ischemic Attack or cryptogenic stroke. IrisFITTM PFO occluder is made from nano-scale Titanium Nitride (TiN) coating technology that reduces nickel elution.

Competitive landscape

Key players operating in the patent foramen ovale closure device industry include Abbott, W. L. Gore and Associates, Occlutech International AB, Heartstitch, Starway Medical Technology Inc., Lifetech Scientific, Cardia, Inc., and pfm medical ag.

The collaboration between companies to develop and market patent foramen ovale closure device, increasing clinical studies on patent foramen ovale closure device, rising investment in developing patent foramen ovale closure device by the manufacturer, and commercialization of regulatory approved patent foramen ovale closure device are some of the strategies adopted by the major players. For instance, on April 03, 2018, Gore Cardioform septal occluder has received the FDA approval for patent foramen ovale (PFO) closure to prevent recurrent ischemic stroke. The device was approved for closure of atrial septal defects (ASDs) up to 17 mm. The FDA approval of the Gore Cardioform Septal Occluder for PFO closure confirm the heart-brain relationship connecting PFO and stroke.

Patent Foramen Ovale Closure Device Market Key Segments:

By Type

• Amplatzer PFO Occluder
• Other PFO Occluder

By Application

• Hospitals
• Clinics
• Other

Key Global Patent Foramen Ovale Closure Device Industry Players

• Abbott
• W. L. Gore and Associates 
• Occlutech International AB
• Heartstitch
• Starway Medical Technology, Inc.
• Lifetech Scientific
• Cardia, Inc.
• pfm medical ag

What Report Provides

• Full in-depth analysis of the parent Industry
• Important changes in market and its dynamics
• Segmentation details of the market
• Former, on-going, and projected market analysis in terms of volume and value
• Assessment of niche industry developments
• Market share analysis
• Key strategies of major players
• Emerging segments and regional growth potential