Apica Cardiovascular has received the CE mark for its platform Access, Stabilisation, and Closure (ASC) system, which allows for the delivery of aortic and mitral valves through the chest wall and apex of the beating heart. A press release reports that the system is a breakthrough-enabling platform technology that can be used by surgeons in conjunction with minimally invasive surgical techniques
According to the press release, the system delivers large-bore therapeutic devices into the beating heart of patients with structural heart disease, via the apex. It both seals and stabilises the tissue of the access site during therapeutic device delivery, minimising loss of blood from or induction of air to the beating heart. On completion of the therapeutic treatment, it standardises apical access and closure, leading to safer heart operations, decreased procedure time and reduced technical challenges associated with transapical access and closure.
“Clinically, the Apica ASC System is easy to use, standardising apical access and closure. Its ‘sutureless’ access coil minimises both rib spreading and patient pain, providing a dry access site with no peri-sheath bleeding during the transcatheter aortic valve implantation (TAVI) procedure”, commented Thomas Walther, a pioneering surgeon in the field of TAVI based at the Kerckhoff Klinik in Germany. He added: “Apical closure was reliable, rapid, and completely dry, demonstrating a reduction in operative times, blood loss, use of blood products and apical access site complications”.
Following CE Mark Approval, the ASC system will now be selectively launched into specific specialist TAVI centres across Europe, with the focus on safety, technical performance and cost-effectiveness.