ESOC 2017 Roundup: Gore touts lowered ischemic stroke, new brain infarcts in PFO Occluder test

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 ...
Source: Mass Device - Category: Medical Devices Authors: Tags: Cardiac Implants Cardiovascular Catheters Clinical Trials Stryker W.L. Gore & Associates Source Type: news