FDA News

Device to close atrial septal defects approved by FDA

W.L. Gore and Associates announced its occluder device was approved by the FDA for percutaneous closure of ostium secundum atrial septal defects.

The device (Gore Cardioform ASD Occluder) was approved based on the results of the Gore ASSURED Clinical Study of its performance in patients aged 2 to 84 years with atrial septal defects and right heart volume overload, according to a press release from the company.

The device, which can close defects between 8 mm and 35 mm in diameter, demonstrated a 100% closure success rate at 6 months and met all its safety, closure and technical success endpoints in the study, according to the release.

“The FDA approval of the Gore Cardioform ASD Occluder is a significant milestone for innovation in the minimally invasive treatment of [atrial septal defects],” Matthew J. Gillespie, MD, attending cardiologist at Children’s Hospital of Philadelphia, associate professor of pediatrics at the Perelman School of Medicine at the University of Pennsylvania and co-principal investigator of ASSURED, said in the release. “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.”

This illustration shows how the Gore Cardioform ASD Occluder closes atrial septal defects.
Source: W.L. Gore and Associates. Reprinted with permission.

Disclosure: Gillespie reports he is a consultant and primary investigator for Medtronic and W.L. Gore and Associates.

W.L. Gore and Associates announced its occluder device was approved by the FDA for percutaneous closure of ostium secundum atrial septal defects.

The device (Gore Cardioform ASD Occluder) was approved based on the results of the Gore ASSURED Clinical Study of its performance in patients aged 2 to 84 years with atrial septal defects and right heart volume overload, according to a press release from the company.

The device, which can close defects between 8 mm and 35 mm in diameter, demonstrated a 100% closure success rate at 6 months and met all its safety, closure and technical success endpoints in the study, according to the release.

“The FDA approval of the Gore Cardioform ASD Occluder is a significant milestone for innovation in the minimally invasive treatment of [atrial septal defects],” Matthew J. Gillespie, MD, attending cardiologist at Children’s Hospital of Philadelphia, associate professor of pediatrics at the Perelman School of Medicine at the University of Pennsylvania and co-principal investigator of ASSURED, said in the release. “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.”

This illustration shows how the Gore Cardioform ASD Occluder closes atrial septal defects.
Source: W.L. Gore and Associates. Reprinted with permission.

Disclosure: Gillespie reports he is a consultant and primary investigator for Medtronic and W.L. Gore and Associates.