5 September 2013 - Apica Cardiovascular has received CE Mark Approval for its platform Access, Stabilisation, and Closure (ASC™) system that allows for the delivery of aortic and mitral valves through the chest wall and apex of the beating heart.
The ASC system is a breakthrough enabling platform technology that can be used by surgeons, in conjunction with minimally invasive surgical techniques. It delivers large-bore therapeutic devices into the beating heart of patients with structural heart disease, via the apex. The ASC system both seals and stabilises the tissue of the access site during therapeutic device delivery, minimizing 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.
CE Mark Approval for the ASC system was based on successfully meeting all safety and technical performance endpoints in a multi-centre clinical trial conducted in Germany at the Kerckhoff Klinik, Bad Nauheim, University Heart Centre, Hamburg, which performs more than 3,500 heart operations every year, and the Heart Centre, Leipzig. The ASC system demonstrated an excellent safety profile with 100% technical success, superior ease-of-use for surgeons, and reductions in both blood loss and operative time. Follow-up assessments of patients showed that the system provided robust closure, with no post-operative apical bleeding complications and no degradation of left ventricular function.
“Clinically, the Apica ASC System is easy to use, standardizing apical access and closure. Its “sutureless” access coil minimizes both rib spreading and patient pain, providing a dry access site with no peri-sheath bleeding during the TAVI procedure”, commented the study’s principal investigator Prof. Dr Thomas Walther, a pioneering surgeon in the field of transcatheter heart valve implantation based at the Kerckhoff Klinik. “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”. The ASC system was initially developed as a result of collaboration between Apica and a team at Emory University and the Georgia Institute of Technology, Atlanta, USA, led by Drs. Jorge H. Jimenez, Vinod H. Thourani and Ajit P.
Yoganathan. Following initial Series A joint investment by Triventures, an Israeli-based venture capital company and Seroba Kernel Life Sciences, a European venture capital company based in Ireland and the UK, Apica was established in Galway, Ireland and began developing the ASC system in early 2011.
Following CE Mark Approval, the ASC system will now be selectively launched into specific specialist Transcatheter Aortic Valve Implantation (TAVI) centres across Europe, with the focus on safety, technical performance and cost-effectiveness.
In parallel with the limited clinical European launch of the ASC system, Apica is continuing to develop its next generation devices for TAVI, as well as its Universal Port Access System for minimally invasive delivery of Left Ventricular Assist Devices (LVAD’s) without the need for cardiopulmonary bypass in the treatment of congestive heart failure.
Apica has two granted U.S. patents and has also recently received notice of allowances to grant its main patent applications in Japan and Europe, giving the company four granted patents in three key territories - Europe, the USA and Japan.
In a joint statement, Apica board members Dr Daniel O’Mahony, a partner with Seroba Kernel and Michael Geva, Managing Partner at Triventures said:
“Securing CE Mark Approval gives Apica a first-mover-advantage in the rapidly growing TAVI sector and we now expect to see exponential growth in demand for this breakthrough system.”
James L. Greene, who hails from the USA and has over 23 years’ experience in medical devices focused on the treatment of cardiovascular disease, is CEO of Apica Cardiovascular. “Our ASC system has benefited greatly from the synergies associated with NUI Galway’s Innovation Centre, as well as the support of Seroba Kernel, Triventures and Enterprise Ireland”, he said. “It’s a pleasure to work in Galway, which is rapidly becoming a major medical device hub of innovation on a global stage. Apica has provided an excellent example of how a new medical device, which was initially conceived and developed overseas, could be brought to Ireland and developed here so that it can be made available for export to treat patients globally.”
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