CorWave reports strong preclinical results for next-generation heart pump, eyes human trials

CorWave reports strong preclinical trials for heart pump: ©Yidiyim - stock.adobe.com

CorWave, a French medical device company focused on advanced treatments for heart failure, announced that it has achieved preclinical milestones for its next-generation implantable heart pump, clearing the path toward First-In-Human trials.

The company’s proprietary Left Ventricular Assist Device (LVAD), which utilizes a novel wave membrane pumping technology, demonstrated successful performance in long-term animal studies. In one arm of the in vivo testing, the device ran continuously for six months. In another, nine sheep underwent 60-day chronic implants without the use of long-term anticoagulants—an outcome that emphasizes the device's hemocompatibility and resistance to thrombosis. Notably, there were no device failures or signs of clotting.

“This technology has the potential to shape the future of long term mechanical circulatory support,” said Martin Strueber, a cardiac surgeon who worked on the preclinical studies. “Beyond the objectives of the study, additional animals were successfully followed up for six months with convincing pump performance. I am excited to see this new device taking the next steps into clinical practice.”

The CorWave LVAD differs from traditional rotary blood pumps by mimicking the natural pulsing action of the heart. Its ability to synchronize with a patient’s native heart rhythm and adapt blood flow based on activity levels represents a major step forward in personalizing mechanical circulatory support.

According to Sebastian Schulte Eistrup, who also participated in the in vivo studies, the surgical implantations were "uneventful and intuitive." He emphasized that the new control algorithm provided reliable support in both co-pulsation and counter-pulsation modes.

“These results not only meet the highest standards in the LVAD industry but also indicate potential clinical advantages over rotary blood pumps that have been in use since the late 1990s,” added CorWave CEO Louis de Lillers. “Following these significant milestones, the team is now actively preparing for the clinical introduction of the device.”

Advances in cardiac devices: Improving outcomes for heart failure patients

As heart failure continues to affect millions worldwide, innovations in cardiac devices are transforming treatment and improving patient outcomes. Implantable devices such as LVADs, cardiac resynchronization therapy (CRT) systems, and leadless pacemakers are becoming increasingly sophisticated, offering patients longer life expectancy and better quality of life.

LVADs like CorWave’s are particularly important for patients with advanced heart failure who are not candidates for transplant. Traditional rotary pumps, while life-extending, have been associated with complications such as blood clots, gastrointestinal bleeding, and stroke. CorWave's wave membrane pump, designed to preserve a more physiological blood flow and reduce shear stress on blood cells, represents a promising shift in addressing these complications.

Meanwhile, leadless pacemakers such as Medtronic’s Micra system have eliminated the need for leads and surgical pockets, reducing infection risks and improving cosmetic outcomes. CRT devices, which resynchronize the heart's ventricles, are now equipped with adaptive algorithms and remote monitoring capabilities that fine-tune therapy in real time based on a patient’s condition.

In addition, artificial intelligence and machine learning are beginning to influence device programming, predicting adverse events before they occur and personalizing therapies like never before.