CorWave announced today that chronic in vivo studies of its implantable heart pump have proven “unprecedented” with strong results.
Presenting at the annual meeting for the International Society for Heart and Lung Transplantation (ISHLT), CorWave touted the study as the first ever to demonstrate sensorless synchronization of a pericardial pump with the native heart for over 30 days, according to a news release.
Clichy, France’s implantable left ventricular assist device (LVAD), which uses its breakthrough wave membrane pump technology, is designed to offer a wide range of flow conditions, gentle blood propulsion and to generate physiologic pulsatility in an effort to reduce the adverse events associated with current LVAD technologies.
Study results from the trials in which the CorWave device operated in pulsatile mode by synchronizing with the native heart without the aid of sensors demonstrated more than 97% success in detecting heartbeats. CorWave said that is the first time in the world that a miniaturized, pericardial pump has accomplished such a feat.
The 30-day results also provided confirmation of the success with CorWave’s LVAD in hemocompatibility, the company said, representing a major milestone in the device development.
“This study is an important step towards making our next-generation heart pump available to patients with advanced heart failure,” CorWave CEO Louis de Lillers said in the release. “Indeed, we demonstrated that our pump is able to work in synchrony with the native heart and can be a game-changer for the LVAD therapy. Congratulations to our team for achieving this milestone in the development of our breakthrough technology. With this study, they are redefining the state of the art in the field of mechanical circulatory support, by succeeding in doing what current devices cannot do.”
In January, CorWave raised $40 million to aid in finalizing the device, producing the heart pumps and starting clinical trials. The company said the recent study results will allow the development of the pump to complete ahead of production and those clinical trials.