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Apica Receives CE Mark Approval for ASC™ System

Thursday, 5 September 2013

Dublin, September 4th, 2013 – Galway based 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.

Apica’s device, based on an idea originated in Emory University and Georgia Institute of Technology (Atlanta, USA), has been developed in Galway, Ireland. The company set up in Galway in 2011 on foot of a joint investment by Seroba Kernel Life Sciences, an Irish venture capital company headquartered in Dublin and Triventures, an Israeli based VC company. The project has also been supported by Enterprise Ireland. Since this investment, Apica has fast-tracked development of its platform technology in Galway from prototype through to CE mark approval within just 30 months.

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”.

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.

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. 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 statement, Dr Daniel O’Mahony, a partner with Seroba Kernel and a board member of Apica, said: “Apica has developed this game-changing medical device in Ireland, leveraging the wealth of medical expertise that is present in the Galway area. It is testament to the employees based on Galway and the teams of experts within the Galway medttech cluster that the company has achieved CE Mark in just 30 months from our initial investment. 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.”


For further information, please contact:

Vicky La Touche-Price

+353 1 6334028
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