SeptRx Launches European Testing of New Device to Treat PFO

SeptRx Launches European Testing of New Device to Treat PFO

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 today 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).

“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 commercialization 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 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).

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.

The SeptRx® Intrapocket PFO Occluder (IPO) was developed based on an innovative approach to addressing the unique anatomical and physiological challenges of the PFO. The unique characteristics of the SeptRx® IPO are as follows:

- Unlike first generation PFO closure devices, the SeptRx® IPO directly treats the pocket of the PFO while minimizing the impact to the atrial spaces, especially minimizing the residual material in the left atrium.

- The flat frame of the SeptRx® IPO applies a gentle force to the PFO tunnel to laterally stretch the tissues and flatten the pocket of the PFO to bring the septal surfaces together and trigger the body’s natural adhesion response.

- The internal mesh of the SeptRx® IPO promotes permanent occlusion of the tunnel, while simultaneously providing an immediate inhibitor to the conduction of emboli.

- The SeptRx® IPO is delivered via a low profile (9 Fr), over-the-wire delivery system for increased safety and ease-of-use.

- The SeptRx® IPO has excellent radiopacity and is fully recapturable.

The first-generation of the SeptRx® IPO device successfully completed an 11-patient first-in-human (FIH) study in 2007. SeptRx is currently finalizing commercial development and will soon begin its clinical trials required for regulatory approval in various markets around the world.

NOTICE: The SeptRx® IPO has not been approved for sale in any regulatory jurisdiction. Further, it is not yet available for either investigational use or commercial sale in the United States.

The SeptRx® Intrapocket PFO Occluder (IPO) was developed based on an innovative approach to addressing the unique anatomical and physiological challenges of the PFO. The unique characteristics of the SeptRx® IPO are as follows:

- Unlike first generation PFO closure devices, the SeptRx® IPO directly treats the pocket of the PFO while minimizing the impact to the atrial spaces, especially minimizing the residual material in the left atrium.

- The flat frame of the SeptRx® IPO applies a gentle force to the PFO tunnel to laterally stretch the tissues and flatten the pocket of the PFO to bring the septal surfaces together and trigger the body’s natural adhesion response.

- The internal mesh of the SeptRx® IPO promotes permanent occlusion of the tunnel, while simultaneously providing an immediate inhibitor to the conduction of emboli.

- The SeptRx® IPO is delivered via a low profile (9 Fr), over-the-wire delivery system for increased safety and ease-of-use.

- The SeptRx® IPO has excellent radiopacity and is fully recapturable.

The first-generation of the SeptRx® IPO device successfully completed an 11-patient first-in-human (FIH) study in 2007. SeptRx is currently finalizing commercial development and will soon begin its clinical trials required for regulatory approval in various markets around the world.

NOTICE: The SeptRx® IPO has not been approved for sale in any regulatory jurisdiction. Further, it is not yet available for either investigational use or commercial sale in the United States.

Source : http://www.septrx.com/technology.html

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