HOUSTON, TX--(Marketwire - Jun 14, 2012) - MicroMed Cardiovascular, Inc., manufacturer of the HeartAssist 5™ Left Ventricular Assist Device (LVAD), today announced it has received approval from the U.S. Food and Drug Administration (FDA) to conduct an Investigational Device Exemption (IDE) Clinical Trial study of the HeartAssist 5™ LVAD System compared to the HeartMate II® VAD.
David Mackstaller, CEO of MicroMed, said, "We have been working non-stop for nearly two years to be permitted to begin this IDE study. This is very a significant event and it marks our entry on to a path similar to the one followed by Thoratec for its HeartMate II® and by HeartWare for its HVAD."
We believe that the study will be watched with great interest because it is a "Prospective, Randomized, Multicenter Clinical Trial to Evaluate the Safety and Efficacy of the HeartAssist 5™ LVAD System compared to the HeartMate II® VAD for Left Ventricular Support in Patients Awaiting Cardiac Transplantation."
The study is expected to enroll 192 patients from up to 20 institutions and follow-up until patients are no longer supported by the device. Patients who meet study criteria will randomly receive either a HeartAssist 5™ LVAD or HeartMate II®. The effectiveness of the VADs in providing circulatory support as a bridge to transplant will be assessed.
Cindy McKelroy, MicroMed's Vice President for Quality Systems and Regulatory Affairs, emphasized that, "MicroMed is proceeding deliberately and carefully to incorporate lessons learned from the FDA Panel hearing for HeartWare's HVAD." In addition, she said, "We intend to conduct the study only at highly qualified and well recognized hospitals. We will release the name of each participating hospital after we have received final approval from its Institutional Review Board."
The HeartAssist 5™, originally developed by the world famous heart surgeon Dr. Michael DeBakey in partnership with NASA, is the smallest and lightest full support LVAD in the world, weighing only 92 grams, and is nearly silent. Because of its miniature size, it is one of the few LVADs that can be implanted above the diaphragm, adjacent to the heart, and is the most technically advanced device among a small number of competitors in this field. It is the only LVAD with a precise, direct flow measurement system and cellular-based remote monitoring (pending approvals). The HeartAssist 5™ System consists of two devices: MicroMed HeartAssist 5™ LVAD and the MicroMed Controller.
Sailesh Saxena, MicroMed's CFO, said, "If MicroMed was a public company, I am sure our stock price would have jumped the moment we received approval from the FDA to begin our IDE Study. MicroMed has achieved a significant valuation milestone that we expect to be recognized by the institutional investors we are approaching to help us with the study and expansion in Europe."
The HeartAssist 5™ System received CE approval for use in Europe in April 2001.
About MicroMed Cardiovascular, Inc.
MicroMed is a pioneer in the accelerating field of Mechanical Circulatory Support. Using advanced technologies, MicroMed manufactures the powerful, miniature, implantable electric HeartAssist 5™ Left Ventricular Assist Device that increases the cardiac output of a failing heart. The Next Generation HeartAssist 5™ system is currently sold commercially outside of the United States and the wireless system is not yet approved for human use. http://www.micromedcv.com/us/