SeptRx, Inc. of Fremont, CA has announced the start of the new InterSEPT clinical trial in Europe, which will provide additional safety and efficacy data about the company’s percutaneous transcatheter SeptRx Intrapocket PFO Occluder (IPO). The device is designed to repair patent foramen ovale (PFO) by bringing the septal surfaces together, without leaving much trace on both sides of the interatrial septum. The IPO device performed favorably in an initial trial, and SeptRx plans to apply for CE Mark approval following this latest trial.
Some more specifics from the product page:
• 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.
Press release: SeptRx® Begins CE Mark Trial of the SeptRx® Intrapocket PFO Occluder (IPO)…
Product page: The SeptRx® Intrapocket PFO Occluder (IPO)…
