CorWave this week presented positive interim results from its first-in-human study of the CorWave Left Ventricular Assisting System (LVAS) at the 2025 Heart Failure Society of America annual meeting.
The device was implanted for the first time on May 28 at St. Vincent’s Hospital in Sydney. It met its primary endpoint with no device-related adverse events at 30 days. The patient’s functional status improved to NYHA class I before discharge, and the device was explanted without complication after a successful heart transplant on day 84.
Investigators also reported that the pump delivered full circulatory support, restoring a cardiac index above 2.5 L/min/m² and efficiently unloading the left ventricle. The membrane design preserved an aortic pulse pressure of 25.5 ± 6.1 mmHg, periodically exceeding 40 mmHg, and allowed consistent aortic valve opening.
“The results of the CorWave device are very encouraging. The physiologic pulse that we observed in the first CorWave patient stands out from the results we have observed in patients assisted with continuous-flow LVAD, in use since the 2000s,” said Chris Hayward of St Vincent’s Hospital, principal investigator of the study. “This first experience suggests that CorWave LVAS can be implanted safely and has the potential to offer significant benefits for patients with heart failure. Further clinical experience will be needed to confirm these promising findings.”
CorWave CEO Louis de Lillers said the early findings highlight the potential benefits of physiologic pulsatility and mark progress toward improved outcomes for advanced heart failure patients.
Related: LVADs save lives: So why aren’t more available?
“We are delighted with these first results from our FIH Study and grateful to see the first transplant successfully completed. The pulsatility performance of CorWave LVAS is remarkable, and our goal is to translate that into improved outcomes for advanced heart failure patients. These results are a testament to the groundbreaking work conducted by our engineering team and the St Vincent’s clinical team,” de Lillers said.
The CorWave FIH study will enroll at least four patients before advancing to a pivotal trial.
More about the CorWave LVAS
France-based CorWave’s LVAS is built on the company’s proprietary wave membrane technology, which it says takes inspiration from the swimming motion of aquatic animals.
Unlike rotary pumps such as Abbott’s HeartMate, the current standard of care that delivers a continuous and fixed flow rate, CorWave’s design is intended to mimic the natural rhythm of the heart and preserve the physiological balance of the cardiovascular system.
CorWave designed the technology to automatically adjust blood flow based on a patient’s activity, whether at rest or in motion. By working in synch with the heart, the LVAS maintains the effects of heartbeats on the vasculature and supports the preservation of cardiac function and structures.
Read more: What is a left ventricular assist device and how does it work?
According to CorWave, the goal of the technology is to reduce serious complications linked to existing heart pumps, including stroke, bleeding, heart failure, and valvular disease. The company also said it aims to improve the quality of life for patients and promote heart recovery.
