WL Gore & Associates has announced that its Cardioform Septal Occluder has achieved 10 years of clinical use, treating patients through clinical studies and commercially in approved indications globally. The device offers an option to treat patients with atrial septal defects (ASD) and patent foramen ovale (PFO).
The device is backed by the Gore REDUCE Clinical Study, a study in which 664 patients were enrolled to evaluate whether PFO closure with the Cardioform Septal Occluder or the Helex Septal Occluder plus antiplatelet therapy significantly reduces the risk of stroke compared to antiplatelet therapy alone.
The REDUCE Study is the only US Investigational Device Exemption (IDE) study that achieved its primary endpoint and over five years showed a significant reduction in recurrent ischaemic stroke across all PFO anatomies compared to medical therapy alone.
“The impact and longevity of the Gore Cardioform Septal Occluder illustrate Gore’s ongoing commitment to helping patients,” said Jens Erik Nielsen-Kudsk, cardiology department clinical professor at Aarhus University Hospital in Aarhus, Denmark, investigator for the Gore REDUCE Clinical Study and consultant for Gore. “Gore engineers worked closely with healthcare professionals to understand what patients need and created a device that conforms to the individual anatomy.”
“This major milestone shows that the Gore Cardioform Septal Occluder is meeting a recognised unmet need. We continue to see health care providers around the globe trusting and choosing this device for their patients,” said Jake Goble, innovation leader, Medical Products Division at Gore. “We are grateful to see how our unique design has played an impactful role in the improvement of patients’ lives. We remain excited about future opportunities to extend the reach of this technology benefitting underserved patient populations.”
The Gore Cardioform Septal Occluder is a permanently implanted device approved in the USA and European Union for the percutaneous, transcatheter closure of ostium secundum atrial septal defects up to 17mm. The device received US Food and Drug Administration (FDA) premarket approval for the percutaneous closure of PFO in 2018. It is also approved in the European Union for percutaneous closure of PFO.