A Milestone for MicroMed Cardiovascular
On June 14, 2012, MicroMed Cardiovascular Inc. made a significant step forward in the development of the LVAD HeartAssist 5®. On this date, it was announced that the US Food and Drug Administration (FDA) has issued an Investigational Device Exemption (IDE), a medical study comparing results of the HeartAssist 5® with those of Thoratec's HeartMate II® LVAD.
David Mackstaller, CEO of MicroMed, said in a statement: “We have worked non-stop for two years to obtain approval for this IDE study. This is a very important event and marks our first sheaths in the development of the LVAD following Thoratec with the HeartMate II® and HeartWare with the HVAD.
We expect this study to be followed with great interest as it will be a potentially randomized multicenter medical trial. It is important to evaluate the safety and efficiency of the HeartAssist 5® compared to the HeartMate II® in patients waiting for a heart transplant.”
The study involves 192 patients in 20 institutions participating and being followed until the patients are no longer supported by an LVAD. Patients who meet the study's criteria will randomly receive a HeartAssist 5® or a HeartMate II® LVAD. The effectiveness of the two LVADs in providing the blood circulation as a bridge to transplantation will be judged on this.
Cindy McKelroy, MicroMed's Vice President for Quality Systems and Regulatory Affairs, emphasizes that, “MicroMed listened closely to the FDA Panel hearing on HeartWare's HVAD and applied the important lessons learned in the development of the HeartAssist 5 ®.” then she says “The design is that this study will only be conducted in well-qualified and accredited hospitals. The names of these hospitals will be released once we have final approval from their Institutional Review Board (IRB).”
The HeartAssist 5®, originally developed by renowned heart surgeon Dr. Michael Debakey in collaboration with NASA, is the smallest and lightest LVAD in the world. Weaving only 92 grams, it is virtually silent. Because it is so small, it is one of the few LVADs that can be implanted above the diaphragm of the abdominal cavity, right next to the heart in the pericardium, and is the most technically advanced pump in the small group to have a similar system.