Velocimed LLC

Closure device for congenital heart defect gets CE Mark, manufacturer announces

Published in Surgery Litigation and Law Weekly, February 4th, 2005

Velocimed LLC, a privately held company, announced that is has received the CE Mark for the Premere PFO Closure System, a new transcather PFO closure device for closure of a patent foramen ovale.

A patent foramen ovale is a flap-like opening in the atrial septum that fails to close after birth in approximately 25%-30% of the population. Under certain circumstances, this flap-like opening may allow emboli to abnormally shunt from the right to the left atria, increasing the risk of ischemic stroke.

Several studies have demonstrated a significantly higher incidence of PFO in patients suffering from cryptogenic stroke (40%-50%), as compared to the...

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Source: Surgery Litigation and Law Weekly (2005-02-04)

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