Nitinol Medical Technologies Announces First Human Implants of New Device

Nitinol Medical Technologies Inc. has announced the first human implants of its new CardioSEAL Occluder with STARflex centering system. Gerd Hausdorf M.D., chief of Cardiology, successfully closed five atrial septal defects in children at the Medical University of Hannover in Germany.

The proprietary STARflex design incorporates flexible microsprings that allow the device to self-adjust to variations in the anatomy of the septal defect without deforming the septum and interfering with the heart valves. The device was designed to overcome cardiologists' concerns with the stiffness and high metal mass of other self-centering devices.

The STARflex was awarded the CE mark in mid-September, and commercial release was initiated with the clinical cases completed in Hannover this week. Marketing rollout to additional centers outside the U.S. will begin immediately.