W.L. Gore said yesterday that it won CE Mark approval in the European Union for its Cardioform ASD septal occluder for the percutaneous, transcatheter closure of ostium secundum atrial defects.
The device won pre-market approval from the FDA for Cardioform ASD in June. The device is designed to close atrial septum defects of 8mm to 35mm in diameter, larger than its predecessor device for defects up to 17mm.
“As the latest extension of the Gore Cardioform Occluder family, the Gore Cardioform ASD Occluder builds on a legacy of safety,” structural heart pipeline leader Jake Goble said in prepared remarks. “Leading interventional cardiologists worldwide informed its development, and its design builds on decades of clinical experience and manufacturing excellence.”
“Larger defects typically have a greater risk for complications, like pulmonary hypertension, right heart enlargement or atrial fibrillation. But previously, Europe didn’t have access to the Gore Cardioform ASD occluder for this range of defects,” added Dr. Matthew Gillespie of the Children’s Hospital of Philadelphia. “CE Mark makes this soft, conformable device available for the minimally invasive treatment of a broader range of ASDs.”