W.L. Gore & Associates today announced successful launch of its GORE Septal Occluder Clinical trial, enrolling the 1st of 50 patients to evaluate the company’s heart implant in treatment of atrial septal defect.
The new catheter-based septal occluder is a permanent implant designed to treat holes in the septum between the chambers of the heart.
The GORE trial will compare the new septal occluder to the outcomes from the company’s previous-generation Helex occluder studies, collecting data at 6 months post-procedure and following patients for 3 years, according to a press release.
"The first procedure using the GORE Septal Occluder was successful and the patient is doing well, having left the hospital the next day," treating physician and Duke University Medical Center Congenital Heart Center chief Dr. John Rhodes said in prepared remarks. "The Gore device has an exceptional design that makes it easy to deploy, and the innovative ePTFE material conforms to the heart for optimal patient outcomes. It is critical for physicians to help complete studies like this in an effort to get new and novel technologies into the hands of doctors to aid patient needs."
Gore’s new septal occluder last year won CE Mark approval in the European Union with indication to treat atrial septal defect and patent foramen ovale. More than 1,500 of the devices have already been implanted worldwide.
Earlier this year the older Helex implant underwent review
by the FDA’s Center for Devices & Radiological Health, alongside rival septal occluder maker St. Jude Medical (NYSE:STJ) and its Amplatzer implant.
That panel recommended that CDRH re-analyze existing data for Amplatzer, which St. Jude acquired along with AGA Medical for $1.03 billion in 2010. Amplatzer was the 1st such device on the U.S. market, winning pre-market approval in 2001. Gore’s Helex followed in 2006.
The timing of Gore’s announcement coincides closely with next week’s Transcatheter Cardiovascular Therapeutics conference in Miami, where study results for devices used to treat patent foramen ovale defects in the heart are set to take center stage, especially a pair of trials evaluating the Amplatzer PFO occluder to medical therapy.
