SeptRx begins CE mark trial of intrapocket PFO occluder


SeptRx, an emerging medical device company that is developing the SeptRx intrapocket PFO occluder – a platform for the percutaneous transcatheter closure of patent foramen ovale (PFO) –announced in June 2011 that the first implants have been completed in the InterSEPT clinical trial at the CardioVascular Center at Sankt Katharinen Hospital, Frankfurt, Germany, under principal investigator Horst E Sievert.

InterSEPT (In-tunnel SeptRx European PFO trial) is a prospective, multicentre, single-arm safety and efficacy trial of the SeptRx intrapocket PFO occluder. Data from InterSEPT will be used to apply for CE marking. The SeptRx intrapocket PFO occluder has already completed a successful 11-patient first-in-human clinical trial. The trial was the first and only PFO device trial to demonstrate 100% closure and 100% safety (out to three years).


“Stroke is an international health issue, the second most common cause of death and the most common cause of disability worldwide,” said Scott Russell, CEO. “Unfortunately, some 20% of all strokes can be attributed to PFO. SeptRx believes that we can have a dramatic influence on lowering this deadly risk. Indeed, we expect that our InterSEPT trial results will position us for initial commercialisation efforts in Europe.”