CorWave Reports Positive Interim Results for First-in-Human Heart Pump Implant

CorWave is sharing encouraging interim results from a first-in-human study evaluating its Left Ventricular Assisting System (LVAS)—reportedly the first heart pump based on breakthrough wave membrane technology.

Doctors implanted the CorWave LVAS—a next-generation durable heart pump—in a patient on May 28 at St. Vincent’s Hospital in Sydney (Australia) by Dr. Paul Jansz. This implantation represented a major technological milestone in durable mechanical circulatory support, according to the company.

The study achieved its primary endpoint, and trial administrators observed no device-related adverse events at 30 days, thus providing an early confirmation of the CorWave LVAS’s safety profile. Functional status improved to NYHA class I prior to discharge. On post-operative day 84, the patient successfully underwent a heart transplant; the CorWave device was explanted without complication, and preliminary analyses of the pump and outflow graft revealed no thrombus.

“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 work conducted by our engineering team and the St Vincent’s clinical team,” CorWave CEO Louis de Lillers said.

The pump performed as expected, providing full support and restoring a cardiac index above 2.5L/min/m² (1.6L/min/m² pre-operative), efficiently unloading the left ventricle. The unique membrane technology preserved an aortic pulse pressure of 25.5 ± 6.1 mmHg, periodically exceeding 40 mmHg and allowed consistent aortic valve opening despite post-operative LVEF of 15% to 20%.

“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 Prof. Chris Hayward, M.D., a cardiologist at St Vincent’s Hospital and principal study investigator. “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.”

The CorWave FIH Study plans to enroll at least four patients before starting the pivotal trial phase.

CorWave is a French company that develops and manufactures cardiac assist devices. Its undulating membrane is touted as a breakthrough technology that distinguishes itself from currently marketed LVADs through its physiological operation, designed to reproduce pulse and blood flow velocities similar to a healthy heart. Ultimately, CorWave’s membrane pump technology should reduce complications associated with current devices and improve the management of heart failure patients. A French Tech 120 member, CorWave was founded in 2012 by the startup studio MD Start and is funded by renowned investors including Bpifrance, EIC Fund, Montpensier Arbevel, M&L Healthcare, Novo Holdings, Seventure Partners, Sofinnova Partners, Ysios Capital, and Vlerick Group. The company has raised more than €80 million in equity funding and employs about 100 people. In October 2023, after more than 10 years of research and development, CorWave scaled up to industrial operations with the inauguration of its state-of-the-art urban factory in Clichy.