Ireland-Based Start-Up Gets CE Mark for Heart Access Device

Apica Cardiovascular has received CE mark for its 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.

According to the company, the ASC system can be used by surgeons, in conjunction with minimally invasive surgical techniques to deliver large-bore therapeutic devices into the beating heart of patients with structural heart disease, via the apex. The ASC system seals and stabilizes the tissue of the access site during device delivery, minimizing loss of blood from or induction of air to the beating heart.

CE mark was based on successfully meeting all safety and technical performance endpoints in a multi-center 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 percent technical success, superior ease-of-use for surgeons, and reductions in both blood loss and operative time, company officials reported. 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 (transcatheter aortic valve Implantation) procedure,” said Thomas Walther, M.D., the study’s principal investigator and 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 in Atlanta, led by doctors Jorge H. Jimenez, Vinod H. Thourani and Ajit P. Yoganathan. Following initial Series A joint investment by Triventures, an Israel-based venture capital company and Seroba Kernel Life Sciences, a European venture capital company based in Ireland and the United Kingdom, Apica was established in Galway, Ireland, and began developing the ASC system in early 2011. 

Following CE mark, the ASC system now be selectively launched into specific specialist TAVI centres across Europe. Apica also 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 (LVADs) without the need for cardiopulmonary bypass in the treatment of congestive heart failure. 

Apica was granted U.S. patents and 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/

“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,” said James L. Greene, CEO of Apica Cardiovascular. “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.”