SeptRx reports first 20 patients have been enrolled in its â€œInterSEPT" CE Mark trial of the SeptRx Intrapocket PFO Occluder
InterSEPT data will be used to apply for CE marking for the SeptRx® IPO. The SeptRx® IPO has previously completed a successful 11-patient first-in-human (FIH) clinical trial. SeptRxs FIH trial was the first and only PFO device trial to demonstrate 100% closure and 100% safety (out to 3 years).
"We are very pleased with the strong start to our InterSEPT clinical trial," said Scott Russell, 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 centers 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."
PFO is a tunnel-like defect connecting the right atrium with the left atrium. A remnant of fetal circulation, it usually seals itself within a few months after birth. Unfortunately, in about 25% of the population the PFO does not fully close and may allow blood (and emboli) to pass directly between the right and left atria. The presence of a PFO has been identified as a contributing factor in cryptogenic stroke, chronic migraine, decompression sickness, and obstructive sleep apnea. A PFO contributes to these conditions by providing a pathway for emboli (blood clots, air bubbles) in the venous system to reach the arterial system by passing directly from the right atrium to the left.
SeptRx, Inc. is an emerging medical device company that has developed the SeptRx® Intrapocket PFO Occluder (IPO), a platform for the percutaneous transcatheter closure of a heart defect known as patent foramen ovale (PFO).
NOTICE: 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 U.S.
Posted by Sean Fenske, Editor-in-Chief, MDT