Gore has completed enrolment for the pivotal phase of its Gore ASSURED Clinical Study. This investigational device exemption (IDE) trial is researching the company’s Cardioform ASD Occluder for the interventional closure of atrial septal defects, sized 8mm to 35mm.
A press release reports that the Cardioform ASD Occluder has been designed to have a unique, anatomically adaptable waist to accommodate the natural anatomy of the heart and mitigate the potential for cardiac injury.
The Gore ASSURED study is a prospective, 22 site, US-based IDE study designed to evaluate the safety and effectiveness of the Cardioform ASD Occluder in the treatment of ostium secundum atrial septal defects. The pivotal stage of the study includes 125 patients and three years of follow-up, with patients being assessed for technical, safety, and closure success at six months. Results are expected in mid-2018, which will allow Gore to submit to the FDA for device approval. Robert Sommer (Columbia University Medical Center, USA) and Matthew Gillespie (Children’s Hospital of Philadelphia, USA) are the co-principal investigators of the study.
Gillespie comments: “The Cardioform ASD Occluder represents an exciting innovation in the endovascular treatment of larger atrial septal defects. The larger the defect, the greater the risk for complications and this makes the repair of larger atrial septal defects imperative. As we consider closure of large atrial septal defects today, we must be mindful of the potential risks associated with the long-term interaction of the device with the heart. Completion of enrolment brings us one step closer toward having a unique conformable alternative for the closure of large atrial septal defects, potentially reducing the risk of cardiac injury for these patients.”
As part of the Cardioform Occluder family, the Cardioform ASD Occluder has been designed with a minimal metal frame covered in Gore’s proprietary, ePTFE film technology to facilitate tissue ingrowth that permanently closes ASDs. The device has five device size offerings that are able to treat a broad defect range.
The Cardiofrom Occluder family also includes the Cardioform Septal Occluder, which received FDA approval in 2015 for the treatment of atrial septal defects up to 17mm. In May of this year, positive results were announced from the REDUCE clinical study, which assessed use of the device in the closure of patent foramen ovale (PFO) for the reduction of recurrent ischaemic stroke and new brain infarct. Gore intends to leverage the REDUCE data to seek FDA approval for a PFO indication for the GORE Cardioform Septal Occluder.