Vesalius Cardiovascular Inc. (VCI) is a pre-clinical stage medical device company currently developing novel percutaneous therapies for the treatment of mitral regurgitation. Today they announced the successful completion of their first 30-day chronic animal study using their mitral valve repair device. The predetermined endpoints of the study were the absence of device or valve thrombosis and the absence of leaflet injury due to the device, and both endpoints were robustly confirmed upon completion of the study.
“We are extremely pleased with the result of our first chronic study,” said Dr. Peter Skarsgard, veteran cardiac surgeon and VCI’s President, who performed the procedure with the help of Dr. Christopher Durkin, a cardiovascular anesthesiologist, echocardiographer, and VCI’s Echocardiography Advisor. Echocardiographic images were obtained during the procedure, and subsequently at 7, 15, and 30 days, followed by a detailed ex-vivo examination of the heart and the implanted device. “This is the first chronic study with our leaflet remodeling device, and I can confirm the complete absence of thrombosis or any injury to the valve leaflets from contact between our remodeling device and the native leaflets. This is an extremely important milestone in the development of our solution,” added Dr. Skarsgard.
Prior to the chronic study, the VCI team performed 17 successful in-vivo acute experiments in 2019. “This positive result is a byproduct of the risk mitigation strategy in our development plan that VCI put in place at an early stage,” mentioned Vincent Ledoux, VCI’s Chief Operating Officer, adding that “30 days of data is extremely significant at this stage. In addition to the main endpoints, our other observations from this study will directly inform design decisions going forward, to ensure that our complete system which includes the device itself as well as the delivery system, is safe, effective, durable, and adoptable.”
Armed with seven biomedical engineers who receive daily clinical inputs from the company’s four specialized physician advisors, VCI aims to produce a surgically inspired implantable medical device that can repair degenerative mitral regurgitation, a very common and potentially fatal disease, without open-heart surgery. The VCI device will be delivered through a catheter (transfemoral/transseptal) during a procedure that will require an overnight stay in the hospital, followed by two days of patient recovery at home, a remarkable improvement in comparison to recovery from the gold standard treatment of open-heart surgery. Their unique solution saves time, energy and money, and by significant risk reduction, permits the treatment of patients who cannot undergo an open heart surgery due to prohibitive risk.
“This milestone is a high point in a continuum of successes that we expect to achieve during the year, from both clinical and engineering sides, which will allow us to reach the First-In-Human study by end of 2021,” added Dr. Skarsgard.