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Friday, October 27, 2017 1:47:43 PM
Yeah pretty sure Myocath was approved by FDA in 2009.
Here is some additional info on Myocath:
Myocath info:
http://www.prnewswire.com/news-releases/bioheart-announces-cell-therapies-program-in-latin-america-for-congestive-heart-failure-and-peripheral-arterial-disease-patients-88949077.html
The MyoCath was developed by Bioheart co-founder Robert Lashinski specifically for delivering new cells to damaged tissue. It is a deflecting tip needle injection catheter that has a larger needle which is 25 gauge for better flow rates and less leakage than systems that are 27 gauge. This larger needle allows for thicker compositions to be injected which helps with cell retention in the heart. Also, the MyoCath needle has more fluoroscopic brightness than the normally used nitinol needle, enabling superior visualization during the procedure. Seeing the needle well during injections enables the physician who is operating the catheter to pinpoint targeted areas more precisely, thus improving safety. The MyoCath competes well with other biological delivery systems on price and efficiency and allows the physician to utilize standard fluoroscopy and echo equipment found in every cath lab.
Howard Leonhardt, Bioheart's Founder and Chief Scientific and Technology Officer, assessing the MyoCath's use in clinical trials stated: "The MyoCath was the primary catheter utilized in Bioheart's Phase I study for the US FDA completed at the Mayo Clinic, Minneapolis Heart Institute, Atlanta Cardiovascular Research Institute and Columbia University Medical Center. It was also the primary catheter used in Bioheart's Phase II study led by Professor Patrick Serruys in Europe. Physicians feel that the MyoCath provides superior flexibility along with precision when compared to the alternatives."
Stuart K. Williams, Ph.D., of the University of Louisville and Chief Scientific Officer of Tissue Genesis, Inc., commenting on the MyoCath: "The MyoCath brings an incredible amount of technology to the delivery of cells through an intravascular route to the damaged area of the heart. This is not a trivial problem, and I am impressed with Bioheart's technology in this field. The major attribute of the MyoCath technology is its simple design and implementation. I have seen some incredibly complex technology necessitating a long learning curve before utilization, resulting in significant potential problems. It's all about placement, reproducibility and precision. The MyoCath development team has done a fantastic job."
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