Apica Cardiovascular, a company based in Galway, Ireland, has developed an innovative platform that will help change the game for valve implant procedures requiring transapical access, such as TAVI (transcatheter aortic valve implantation). Using the apex of the heart as the entry point, the Access, Stabilization, and Closure (ASC) system allows surgeons to implant prosthetic aortic and mitral valves, all while the heart continues to beat. Upon a successful implantation, the system standardizes closure by quickly stabilizing and sealing the tissue of the access point without conventional sutures, minimizing blood loss and the chance for an air embolism. The system will help physicians treat structural heart disease quickly, safely, and in a cost-effective manner.
Clinical trials were conducted in multiple centers across Germany and successful results were published in The Thoracic and Cardiovascular Surgeon earlier this year, leading to a recent CE Mark approval. The ACS performed with a 100% technical success rate during the trial (within 2 hours from skin incision) and no complications or left ventricular degradation were observed during 90 day follow-ups. Apica is looking to expand into both the US and Japanese markets as it continues with its limited launch in Europe.
Here’s an interview with the Director of R&D at Apica:
Link: Apica Cardiovascular…
Press release: Apica Receives CE Mark Approval for ASC™ System…