PLEASE NOTE: HYPEREM™IC is not yet approved for use and is for investigational use only. It is currently undergoing clinical evaluation in Europe to generate data with the aim of supporting regulatory submissions.
HYPEREM™IC is an over-the-wire Fractional Flow Reserve infusion microcatheter. It has been designed specifically to enable continuous intracoronary infusion of hyperemic agents over a standard 0.014″ pressure wire. The device has completed pre-clinical evaluation and design verification, and is now under clinical evaluation to support regulatory submissions.
HYPEREM™IC has been specified with the aim of balancing the multiple demands of IC infusion:
Design and development of HYPEREM™IC has been performed in collaboration with Creganna Medical, Galway, under the control of the Diasolve Quality Management System (certified to ISO 13485 standards by BSI). Design verification, biological safety and GLP pre-clinical studies have been completed with confidential reports available. A clinical investigation to validate the design and support CE mark has been initiated at North West London NHS Trust (www.hyperemicstudy.com).