“I was encouraged by the fact that the term used in (the FDA’s) questions was ‘reasonable assurances’ rather than statistical certainty, if such a thing can be attained,” said Dr. Jeffrey Brinker of Johns Hopkins Hospital in Baltimore, according to the TCTMD report. “There is a real clinical need – even if the group turns out to be much smaller than what was studied – for some device to be helpful for the pathophysiology that most certainly exists in some portion of these patients with cryptogenic stroke.”

TCTMD noted that most of the interventional cardiologists on the FDA panel voted in favor of recommending approval while several neurologists voted no on efficacy.


Dr. Seemant Chaturvedi, a neurologist from the University Of Miami School Of Medicine, voted no to all three questions, according to Cardiology Today.

“We are in a world of evidence-based medicine and two trials have shown that the primary endpoint was not met,” Chaturvedi stated.

Dr. Karen Furie, a neurologist from Rhode Island Hospital in Providence, R.I., voted yes on safety and benefits outweighing the risk but voted no on efficacy. She stated that she had concerns but in the end voted yes for safety and benefit/risk because, “I also see a clinical need for this device.”

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