June 16, 2011—SeptRx, an emerging medical device company that is developing the SeptRx® Intrapocket PFO Occluder (IPO)—a platform for the percutaneous transcatheter closure of a heart defect known as patent foramen ovale (PFO)—announced that the first implants have been completed in the InterSEPT™ clinical trial at the CardioVascular Center at Sankt Katharinen Hospital, Frankfurt, under principal investigator Horst E. Sievert, M.D.InterSEPT™ (In-tunnel SeptRx European PFO Trial) is a prospective, multi-center, single-arm safety and efficacy trial of the SeptRx® IPO. 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 (FIH) clinical trial. SeptRx’s FIH trial was the first and only PFO device trial to demonstrate 100% closure and 100% safety (out to 3 years)...
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...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... [PDF] SeptRx' s Press Release -
