A Medical Device Daily

Abiomed (Danvers, Massachusetts) reported the development of a pediatric circulatory support technology. Abiomed said that the device, now in pre-clinical studies, is a catheter-based heart pump similar to the Impella LP2.5. It provides left-ventricular support to small pediatric patients requiring preconditioning prior to a cardiac intervention, or to recover patients who are either post-surgery, cannot be weaned from bypass, or who have endocarditis.

The technology has been designed to operate as either a pulsatile device that can provide up to 120 beats per minute, or as a continuous-flow technology, and is estimated to provide circulatory support for about two weeks. For young patients, recovering the native heart is essential due to the lack of donor organs and also due to the effects of the necessary immuno-suppression which can be challenging for these patients.

The company will present information on the new device at the Third International Conference on Pediatric Mechanical Circulatory Support Systems and Pediatric Cardiopulmonary Perfusion being held in Hershey, Pennsylvania, from May 16-19.

The company plans to pursue CE Mark Approval for this technology in Europe and approval by the FDA under a humanitarian device exemption.