Structural heart disease implant developer Occlutech said today it won CE Mark approval in the European Union for its ventricle septal defect closure device.
The occluding device consists of a flexible nitinol wire mesh, and is indicated for minimally invasive closure of VSDs, the company said.
“We are extremely pleased to be able to provide patients and cardiologists with this innovative product and expect our VSD occluder to significantly add and improve therapy options for this patient population,” CEO Tor Peters said in prepared remarks.
The implantable device will be available in different configurations and sizes and can accommodate a range of ventricle septal defects, the company said.
Occlutech did not comment on any plans for commercialization of the device or if it is pursuing any other regulatory clearances.
Jena, Germany-based Occlutech said the U.K. Patents Court in the High Court of Justice ruled invalid a St. Jude patent covering “Percutaneous catheter-directed intravascular occlusion devices.”