PFO Closure Device Market –Restrain
PFOClosure Device Market is expected to be hindered by product discontinuationor recall. For instance, in 2013, W. L. Gore & Associates, Inc,discontinued its product GORE HELEX Septal Occluder, as a result of sued forpatent infringement. Moreover, in 2013, St. Jude Medical recalled Amplatzer PFOOccluder, assigned as Class I tagged product recall by FDA.
Patent Foramen Ovale (PFO) is amedical condition wherein tissue flap in the wall between left and right atriumremains persistently open, allowing a small amount of blood to pass from theright side of the heart to the left side of the heart. PFO closure device areimplantable device used to treat PFO through a minimally invasive,catheter-based technique, implicated in a number of pathological states,including cryptogenic strokes, transient ischemic attacks, migraine with auras,decompression sickness, and severe refractory hypoxemia. PFO closure devicemarket is driven by high incidence rate for ischemic stroke and new productlaunches.
PFO Closure Device Market –Driver
PFO closure device market ismajorly driven by the high incidence of ischemic stock. Stroke is the secondmost common cause of death in the world. According to the American StrokeAssociation, 2016, annually more than 795,000 people in U.S. suffer fromstroke, of which about 87% of stroke are ischemic strokes. Furthermore,increasing number of congenital heart disease is expected to propel growth ofthe PFO closure device market.
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For instance, according toAmerican Heart Association, around 40,000 infants are born with a congenitalheart defect in the U.S. annually and around 2 to 3 million individuals aresuffering from congenital heart defect. Moreover, increasing adoption of lifestyle related risk factors such as alcohol, smoking, drugs or sedentary lifestyle is expected to elevate the risk of stroke incidence.
Moreover, new product launchesare expected to boost growth of the PFO closure device market during theforecast period. For instance, in April 2018, W. L. Gore & Associates, Inc.received the US FDA approval for its GORE CARDIOFORM Septal Occluder for PFO closureto prevent recurrent ischemic stroke. The study claimed 77% reduction inrecurrent ischemic stroke when PFO closure was combined with antiplatelettherapy, as compared to antiplatelet therapy. Moreover, in 2016, Amplatzer PFOOccluder device was reintroduced after product recall with FDA approval toreduce stroke risk for patients with prior cryptogenic stroke. Furthermore,increasing clinical trials for new device is expected fuel growth of the PFOclosure device market. For instance, as on 2016, Lifetech Scientific (Shenzhen)Co., Ltd. was conducting its Post Market Clinical Follow-up study for itsdevice named IrisFIT PFO Occluder for the indication of PFO.
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PFO Closure Device Market -Regional Analysis
Based on geography, the PFOclosure device market has been segmented into North America, Latin America,Europe, Middle East, Asia Pacific, and Africa. North America holds dominantmarket share attributed to high incidence of ischemic stroke. Furthermore, AsiaPacific is expected to fastest growing PFO closure device market due toincreasing awareness among the population about PFO. For instance, PFO Funding Organization,Australia-based not for profit organization, works to increase public andphysician awareness of the medical condition called patent foramen ovale (PFO)or ‘hole in the heart’ and its importance to cardiovascular and neurologicalhealth.
PFO Closure Device Market –Competitive Analysis
Key players operating in PFOclosure device market includes AGA Medical, Abbott (previously known as St JudeMedical, Inc.), WL Gore and Associates, Swissimplant AG, and Occlutech.
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