MicroMed predicts Q4 start for DELTA ONE trial:
This article was originally published in Clinica
Executive Summary
MicroMed Technology has submitted an investigational device exemption (IDE) application to the US FDA to start a clinical trial to assess its miniaturised cardiac assist device as a long-term treatment for heart failure patients who are not eligible for heart transplantation. The DeBakey ventricular assist device is currently being tested in a pivotal trial in the US as a bridge to transplant and is already approved for sale in Europe. The Houston, Texas firm said that pending FDA approval of the IDE, it planned to begin the new trial, called DELTA ONE, by the fourth quarter of 2002.