In Galway, Ireland on December 11, 2018, Shanghai MicroPort^® CardioFlow Medtech Co., Ltd. (hereinafter referred to as “MicroPort^® CardioFlow”) announced that the first patient enrollment was completed in Europe for the project of pre-market clinical research on its self-developed VitaFlow^® II Transcatheter Aortic Valve and Recyclable Delivery System (hereinafter referred to as “VitaFlow™ II System”) (“VITALE” project for short).

This patient was enrolled by Dr. Darren Mylotte of University Hospital Galway on December 11, European time. The immediate postsurgical results showed no Perivalvular Leak (PVL). Dr. Darren Mylotte said that using an inline catheter sheath for puncture was very smooth, the release process was very stable, and the postsurgical clinical results were perfect.

VITALE is a prospective, multicenter and single-group clinical trial project aiming at assessing the safety and efficacy of the VitaFlow™II system in clinical applications. This research was designed to be carried out at 15 hospitals of 8 European countries. The primary endpoint of this research project is the 12-month cumulative all-cause mortality. The subjects enrolled into the VITALE project will be followed for five years. “While having realized recyclability, the VitaFlow™II system is able to maintain an excellent release stability and good anti-PVL performance. If the product has a competitive price, it would very competitive in the global market,” said Prof. Nicolo Piazza, principal investigator of the VITALE project, cardiologist, famous cardiologist of McGill University Health Centre (MUHC).