In vivo studies demonstrated the pump’s successful operation for a period of up to six months. Additionally, nine chronic ovine implants were conducted for 60 days with no device failure or sign of thrombosis at explant. These significant milestones mark the final stage of CorWave’s preclinical development, paving the way for its First-In-Human study.
CorWave Completes 6-Month In Vivo Study for Clinical Trials Initiation
CorWave, a medical device company dedicated to the fight against heart failure, announces new preclinical results of its implantable heart pump.
CorWave’s in vivo studies demonstrated the pump’s successful operation for six months. Additionally, nine chronic ovine implants were conducted for 60 days, without chronic anticoagulant therapy. There was no device failure during the studies and no sign of thrombosis at explant. The CorWave device operated in pulsatile mode, synchronizing with the native heart rate. These studies underpin the device’s thromboresistance, stable algorithm, and hemocompatibility. These significant milestones mark the final stage of CorWave’s preclinical development, paving the way for its First-In-Human study.
CorWave is developing an implantable LVAD (Left Ventricular Assist Device) driven by its proprietary breakthrough wave membrane pump technology. This unique pumping mechanism, combined with a smart algorithm, enables the CorWave pump to adapt its flow to patients’ activity levels and preserve physiological balance, aiming to reduce adverse events and improve quality of life.
“This technology has the potential to shape the future of long term mechanical circulatory support. It can overcome current limitations of rotary blood pumps and create real smart and adaptive circulatory support: the results of the preclinical studies were excellent. 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.” commented Dr. Martin Strueber, cardiac surgeon who supported the company in the preclinical development.
“CorWave’s novel self-adaptive, smart LVAD has demonstrated excellent preclinical results, with no device-related failures and complications. Surgical implantations were uneventful and intuitive. The newly introduced control algorithm allowed synchronous support, either in co-pulsation or counter-pulsation mode, and operated reliably throughout the study. Safety and feasibility have been successfully demonstrated, paving the way for clinical trials,” added Dr. Sebastian Schulte Eistrup, cardiac surgeon who was also involved in the in vivo studies.
“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. Following these significant milestones, the team is now actively preparing for the clinical introduction of the device,” concluded Louis de Lillers, CEO.