Based in Ireland, Apica Cardiovascular Limited develops technologies that are all about access, designed to make aortic and mitral valve replacement and LVAD implantation possible without the need for cardiopulmonary bypass. The company has updated us with the results of the first clinical application of its Access, Stabilization and Closure (ASC) System which took place during October’s EACTS congress in Vienna.
ASC is Apica’s lead device, enabling and standardising the delivery of aortic and mitral valves through the chest wall and apex of the beating heart with minimal blood loss, reduced complications and a shortened procedure time. The system both seals and stabilises the tissue of the access site during therapeutic device delivery, minimizing loss of blood from or induction of air into the beating heart.
We covered the CE marking of the ASC system back in September, here, following which it saw first use during a live case beamed into this year’s European Association for Cardio-Thoracic Surgery (EACTS) congress in Vienna. Transapical aortic valve replacement procedure using the Apica access, stabilisation, and closure (ASC) system, conducted by Dr. Joerg Kempfert and Dr. David Holzhey live from the Hertzzentrum in Leipzig, Germany.
During the procedure, the ASC system simplified apical access and closure despite a challenging anatomy with significant fatty tissue. The patient presented with a very severe aortic stenosis, yet the ASC system meant the procedure could even be performed with a “non-rib spreading” technique using a soft-tissue retractor. At the end of the procedure, the apical access was securely closed without a single suture.
Apica tells us that follow-up assessments of patients (presumably including the EACTS patient) showed that the system provided robust closure, with no post-operative apical bleeding complications and no degradation of left ventricular function.
The company is currently starting a post-market clinical follow-up registry in limited centres in Germany.
“The Apica ASC system is an easy-to-use method for achieving aortic valve replacement transapically, standardizing apical access and closure”, commented Dr. Kempfert. “My experience with this device in our clinic to date has shown reliable, rapid, and completely dry apical closure, leading to a shortened procedure time, minimal blood loss and reduced apical access site complications”.
“We have been tremendously encouraged by this first successful public demonstration of our innovative transapical access technology”, added James L. Greene, CEO of Apica Cardiovascular. “This reinforces our confidence that our ASC system will soon be routinely accepted as a new standard of care for transapical aortic valve replacement procedures”.
Source: Apica Cardiovascular Ltd.