Gore Takes on Abbott with New PFO Stroke Indication

W.L. Gore &Associates has received FDA approval to expand the indication of the Gore Cardioform Septal Occluder to reduce the risk of recurrent ischemic stroke in patients. The device treats patients through the closure of patent foramen ovale (PFO). Cardioform’s previous indication was for the closure of atrial septal defects that are up to 17mm in size. Gore’s Structural Heart Leader, Jake Goble said Cardioform has the potential to redefine stroke prevention. Goble began working for Gore in 2007. It was around that time the company began to explore the possibility of having the Cardioform focus on stroke prevention. “One of the things we noticed in the literature early on was the connection between PFO and stroke reduction,” Goble, told MD+DI. "We thought this would be ideal for applying into this space of PFO closure.” Here’s the premise behind the device. In a portion of patients there is a conduit between the right and left side of the heart that doesn’t close after birth. In a subset of these patients there could be clots that could form and break free. The clots could pass from the right to  left side of the heart. These clots aren’t necessarily filtered by the body. The unfiltered clots have an open highway to go anywhere on the arterial side and could potentially end up affecting the blood vessels of the brain causing a stroke. “Our device is designed to close that door betwe...
Source: MDDI - Category: Medical Devices Authors: Tags: Cardiovascular Source Type: news

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