W.L. Gore & Associates yesterday released results from the Reduce study of its Cardioform Septal Occluder devices used to close patent foramen ovale, touting a reduction in recurrent ischemic strokes and new brain infarcts.
The Gore Cardioform Septal Occluder is designed to be inserted via catheter and is currently cleared by the FDA for closure of atrial septal defects.
“It is of the utmost importance to us to be transparent and share clinical data as quickly as possible. We completed our two-year primary endpoint follow-up with patients in March and have worked diligently to release these important data to the public. Closure of PFO to Reduce recurrent strokes and brain infarcts is not widely practiced today, mainly due to a lack of sufficient data. We’re excited by the very positive results from our Reduce study. We are looking forward to our next steps of taking the Gore Cardioform Septal Occluder through the submission process to make this viable treatment option for recurrent cryptogenic stroke available to physicians and their patients,” Gore structural heart pipeline leader Jake Goble said in a press release.
The controlled, open-label, 664-patient Reduce study aimed to explore the efficacy and safety of PFO closure with Gore Septal Occluder in patients, ages 18 to 59, with a history of cryptogenic stroke, the Flagstaff, Ariz.-based company said.
The trial met its primary endpoint, reporting a 76.6% reduction in recurrent ischemic stroke in patients treated with the occluder alongside antiplatelet therapy versus those only treated with antiplatelet therapy alone. The average follow-up in the study was 3.4 years, Gore said.
The study also met its co-primary endpoint, showing a 49.6% relative risk reduction for new brain infarct, including silent brain infarct, through PFO closure. The company said that the trial makrs the 1st time a study has explored the relationship between PFO closure and a reduction of new brain infarct.
Data showed no difference in the subject-based rate of serious adverse events, with device and procedure related serious adverse events occurring in 1.4% and 2.5% between the test and control groups, respectively. The rate of serious atrial fibrillation was higher in the test group than the control at 2.3% and 0.4% respectively, but the company said that the majority of AF was peri-procedural, with an 80% onset within 30 days and 70% resolution within 2 days of onset.
“The Reduce data is groundbreaking for patients who have suffered a cryptogenic stroke attributed to a PFO. Until now, there has never been a study of a PFO closure device that showed statistically significant reduction in stroke recurrence in the primary intent-to-treat analysis. Other PFO closure device trials had to rely on secondary analysis, including following patients for up to a decade, before achieving statistical significance. Also of note is the level of safety the Gore Cardioform Septal Occluder demonstrated, with no significant difference shown in the rate of serious adverse events between patients implanted with the device and those in the control arm. This trial demonstrates noteworthy verification that PFO closure with the Gore Cardioform Septal Occluder is a valuable procedure to Reduce recurrent stroke and brain infarct when utilized in an appropriate patient population,” Reduce principal investigator Dr. Scott Kasner of the University of Pennsylvania said in a prepared statement.
Data from the trial will be used to support an expanded FDA indication for the Occluder devices, which the company hopes it will receive by the end of the year.
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