FREMONT, Calif.–(BUSINESS
WIRE)–SeptRx, 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) – reported today that it has completed enrollment of the first 20
patients in its ongoing “InterSEPT” (In-tunnel SeptRx European PFO Trial)
clinical trial at Sankt Katharinen Hospital (Frankfurt, Germany) under
principal investigator Horst E. Sievert, M.D., and at Hôpital Privé Jacques
Cartier (Massy, France) under Jean-François Piéchaud, M.D.
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
