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The APICA Access, Stabilization and Closure (ASC) device is a pre-mounted access and closure system used in transapical transcatheter aortic valve implantations (TA-TAVI). The system is used in conjunction with any current CE-marked transapical heart valve system. The Large Coil Implant connects to the myocardium via a “helical coil” and provides access into the left ventricle of a beating heart whilst providing full hemostasis for the entirety of the procedure. Final closure is achieved using the “Closure Cap” which is introduced through the Access Coil Delivery System and simply threaded into the coil.

Apica Cardiovascular Ltd receive an Irish Times Innovation award

APICA is headquartered in the Business Innovation Centre at NUI Galway and is one of a number of growing medical device and life-science enterprises located there. Being “on-campus” and in close proximity to similar companies gives us tremendous access to a variety of ancillary facilities and resources. The Business Innovation Centre is completely dedicated to the needs of the incubator companies located here and this commitment has been key in minimizing the administrative burden of our company and allowing our engineering team to focus entirely on the development of our product range. Working with NUI Galway Research Centers such as the NFB on materials and the School of Engineering on product development is critical for Apica going forward.

The project began in January 2011 and initially focused on developing and optimizing the technology through a number of acute and chronic animal trials. By the end of 2011 the design was “frozen” and our CE trial began with the first human implant performed in Germany on May 24th 2012. Within 7 months our trial was complete with 31 patients implanted across 3 sites in Germany. CE-mark for the device was obtained in August 2013 and we have been in commercial roll-out in specific German sites since then.

Product Design from Apica Cardiovascular Ltd

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