Gore's Cardioform ASD Occluder Approved by FDA
June 4, 2019—Gore & Associates announced FDA premarket approval of the company's Cardioform atrial septal defect (ASD) occluder for percutaneous closure of ostium secundum ASDs.
Gore stated that the device features an anatomically adaptable waist that conforms to the defect to close ASDs with diameters of 8 to 35 mm, including those without a retroaortic rim, by facilitating optimal tissue ingrowth while maintaining thromboresistance.
According to the company, FDA approval was supported by data collected from the pivotal stage of the ASSURED clinical study, which demonstrated 100% closure success at 6 months in patients who underwent successful implantation.
The pivotal study evaluated the safety and efficacy of ASD closure using the Cardioform ASD occluder in 125 patients with evidence of right heart volume overload demonstrating the need for defect closure. The study included patients who were 2 to 84 years old across 22 investigation sites, including 15 children’s hospitals. The pivotal study met its safety, closure, and technical success primary endpoints.
In Gore's press release, the Coprincipal Investigator of the ASSURED study, Matthew J. Gillespie, MD, commented, “The FDA approval of the Gore Cardioform ASD occluder is a significant milestone for innovation in the minimally invasive treatment of ASDs. This soft, conformable device was not previously available for this range of defects but is now an option for larger defects that typically have a greater risk for complications, including right heart enlargement, atrial fibrillation, and pulmonary hypertension. The ability to retrieve and reposition the Gore Cardioform ASD occluder helps me ensure proper positioning and offers me confident closure.” Dr. Gillespie is a cardiologist at the Children’s Hospital of Philadelphia in Philadelphia, Pennsylvania.
Gore noted that in addition to the Cardioform ASD occluder, the company's occluder portfolio includes the Cardioform septal occluder, which is indicated for ASD closure for defects up to 17 mm and received FDA approval in April 2018 for patent foramen ovale closure to prevent recurrent ischemic stroke.