SeptRx announced that it has completed enrolment of the first 20 patients for its ongoing InterSEPT (In-tunnel SeptRx European patent foramen ovale) clinical trial at Sankt Katharinen Hospital, Frankfurt, Germany, under principal investigator Horst E Sievert, and at Hôpital Privé Jacques Cartier, Massy, France, under Jean-François Piéchaud.
InterSEPT data will be used to apply for CE marking for the SeptRx Intrapocket Occluder (IPO)—a platform for the percutaneous transcatheter closure of patent foramen ovale. In 2007, This device completed a successful 11-patient first-in-human clinical trial which demonstrated 100% patent foramen ovale closure and 100% safety (out to 3 years).
“We are very pleased with the strong start to our InterSEPT clinical trial,” said Scott Russell, SeptRx’s CEO. “Early results look very encouraging, building on the excellent patient outcomes from our first-in-human study. In the coming months we will be expanding our trial into additional centres and introducing our larger, 19-mm device into the trial. When the InterSEPT study is completed, we will use the results to seek CE mark and commence marketing and sales efforts in Europe.”
The SeptRx IPO is not approved for sale in any regulatory jurisdiction. Further, it is not yet available for investigational use or commercial sale in the USA.