PFO Closure Devices Market Research Report 2018

Patent Foramen Ovale (PFO) is a hole in the heart, which can be cured by filling in the gap, using PFO closure devices. PFOs only occur after birth due to closure failure of the foramen ovale. This hole allows blood to pass through the fetal lungs, which cannot work until exposed to air.

Foramen ovale usually closes after a newborn takes its first breath and in 75 percent of individuals it seals within a few months from birth. Failure to close is called a patent foramen ovale. Increasing number of such cases is increasing the demand for PFO closure devices, which in turn is expected to boost growth of the PFO closure devices market. According to American Heart Association, in 2004, around 2000–3000 patients underwent percutaneous closure of a patent foramen ovale (PFO).

This closure technique is considered safe and easy, due to which it is widely being adopted across the globe. This is a minimally-invasive and painful procedure for PFO than surgery. For instance, contemporary devices such as Amplatzer devices, are associated with lower rates of periprocedural complication of as close to 1%. Thus, the demand for PFO closure devices is expected to increase, in turn fueling growth of the PFO closure devices market.

However, PFO has been linked with cryptogenic strokes, recurrent transient neurologic deficits, sleep apnea, decompression illness, and migraines. U.S. Food and Drug Administration has not approved several of PFO closures devices and are thus off-label procedures to close a PFO. Complications also include nickel allergy among patients, which could cause chest pain after implantation. These factors pose as major restraints for growth of the PFO closure devices market.

AMPLATZER™ Septal Occluder Minimally invasive transcatheter closure is the primary treatment option for secundum atrial septal defects. It is designed to oppose the septal wall on each side of the defect and create a platform for tissue in-growth after implantation. 98.5% closure rate with no significant residual shunt (less than 2 mm) at one-year follow-up.

CardioSEAL Septal Occlusion System with Qwik Load is a device specially designed to deliver catheter, a coaxial polyurethane catheter designed, to facilitate attachment, loading, delivery, and deployment of the Occluder to the defect.

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