RESPECT And PC Trial Results In, But Still No Real ‘Closure’ On PFO

Article preview from "The Gray Sheet" - October 29, 2012

There was some expectation leading up to TCT that the two trials could provide a definitive ruling on whether the PFO closure procedure had a future or not. But actual outcomes sparked a range of interpretations.

 
RESPECT And PC Trial Results In, But Still No Real ‘Closure’ On PFO

Article preview from "The Gray Sheet" - October 29, 2012

Industry watchers looking for a clear answer on the fate of the market for patent foramen ovale closure as a stroke treatment at this year’s Transcatheter Cardiovascular Therapeutics annual conference were likely disappointed.

The results from two hotly anticipated studies evaluating St. Jude Medical Inc.’s Amplatzer PFO occluder for patent foramen ovale closure sparked a range of interpretations from practitioners at the Miami meeting.

There was some expectation leading up to TCT that the two trials – RESPECT and PC – could provide a definitive ruling on whether the PFO closure procedure had a future or not. After NMT Medical’s STARFlex PFO-closure device failed to show an advantage over medical therapy in preventing recurring strokes in the CLOSURE I trial in 2010, conventional wisdom was that a negative finding in the St. Jude trials could put the nail in the coffin for the procedure.

But if the studies showed clear positive results, it could spark renewed enthusiasm for PFO closure and help build a consensus that the CLOSURE I findings were primarily the result of specific study and product design issues, some suggested.

Continued...

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