W.L. Gore & Associates today announced that it had won FDA approval to adds its next-generation GORE Septal Occluder to its Reduce clinical study, which is already evaluating its older Helex septal occluder in prevention of recurrent stroke in patients with patent foramen ovale, a hole between the upper chambers of the heart.
Gore hopes to demonstrate that patients treated with its PFO closure devices along with anti-platelet medication have reduced rates of recurrent stroke or transient ischemic attacks when compared with patients taking the drug regimen alone, according to a press release.
The news was released during the Transcatheter Cardiovascular Therapeutics conference in Miami this week, where study results for devices used to treat patent foramen ovale defects in the heart are expected to take center stage.
The Reduce trial, initially launched in 2008, was designed around Gore’s older Helex septal occluder device, a company representative told MassDevice.com today.
The study is still undergoing enrollment and new participants will be randomized to received either drug therapy along with PFO closure with the Helex device, drug therapy along with PFO closure with the Gore device or drug therapy alone, Lear told us.
The FDA has not yet approved any septal occluders for treatment of patent foramen ovale closure, but the Gore device has had CE Mark approval for use in the European Union since June 2011.
Gore’s not the only device maker looking to bring a PFO treatment device to the U.S. market. Medical device giant St. Jude Medical (NYSE:STJ) earlier this year announced that it reached a stopping rule in the Respect clinical trial of its Amplatzer structural heart defect treatment.
That meant the study met the required number of primary events to meet its protocol requirements, and St. Jude closed patient enrollment in the trial. The 980-patient Respect trial examined whether the Amplatzer can prevent "cryptogenic" stroke – strokes whose cause is unknown – in patients with PFO.
The condition is believed to play a role in such mysterious strokes, but linking a treatment with preventing stroke and ischemia proved elusive for at least one other company.
NMT Medical ran aground after a clinical trial of its StarFlex implant for treating PFO failed to show that it could prevent recurrent stroke and transient ischemic attack. W.L. Gore later bought bankrupt NMT’s assets at auction.
In May an FDA panel recommended that the agency’s Center for Devices & Radiological Health re-analyze existing data for St. Jude’s Amplatzer heart implant during a hearing to review safety data for the Amplatzer and for Gore’s Helex implant.
The panel focused primarily on a pair of rare but serious adverse events that have become more apparent with growing use: Erosion of cardiac structures with STJ’s Amplatzer and device fracture with Gore’s Helex.
Just last week Gore announced that it had enrolled its 1st patient in a new study comparing its new GORE septal occluder to outcomes from the company’s previous-generation Helex occluder studies, collecting data at 6 months post-procedure and following patients for 3 years
Gore has estimated that its Reduce trial in August 2014 will finish collecting data for its primary outcomes measures. The estimated study completion date is August 2015.