Occlutech AFR Receives CE Mark for Heart Failure Treatment

Schaffhausen, Switzerland, September 9, 2019 /PRNewswire/ -- Occlutech AG today announced that its atrial flow regulator, the Occlutech AFR, has received CE marking, allowing it to be marketed in the European CE-regulated market. The Occlutech AFR is a next-generation intra-atrial shunt device designed to treat heart failure symptoms by alleviating abnormal intra-atrial pressure. It can be implanted via a minimally invasive procedure at the septum between the left and right atria. Available in various sizes, it supports unique patient-oriented and personalized treatment.

Millions of patients in Europe and around the world suffer from heart failure each year, with hundreds of thousands dying from this condition. Many of these patients experience reduced cardiac output due to left ventricular dysfunction. Consequently, the left atrium becomes enlarged, subject to volume and pressure overload. This leads to the most significant clinical symptoms of heart failure: pulmonary congestion and shortness of breath. By placing the Occlutech AFR within the septum to create a restrictive atrial septal opening while maintaining the appropriate shunt size, intracardiac pressures are significantly reduced, thereby improving cardiac function.

Sabine Bois, Co-CEO of Occlutech AG, stated, “With the CE marking of the Occlutech AFR, we are taking another major step toward becoming a multi-franchise provider of devices for the treatment of congenital and structural heart disease.” She further noted, “The Occlutech AFR has the potential to revolutionize the treatment of heart failure patients with its efficacy, versatility, ease of use, and safety profile.”

Occlutech is one of the leading companies in its field, with multiple flagship products, including state-of-the-art PFO (patent foramen ovale) occluders and ASD (atrial septal defect) occluders. Occlutech markets congenital and structural heart products in over 80 countries and maintains production and R&D facilities in Jena, Germany, and Istanbul, Turkey. Occlutech has developed numerous new products and technologies to improve therapeutic outcomes for patients in these and related fields.www.occlutech.com)