"I am delighted to be partnering with Magenta Medical on this study," said Dr. Sharma. "The three cardinal features of the Elevate™ pLVAD - small insertion profile, ease-of-use, and high pump flow - will enable us to benefit many more appropriately selected complex PCI patients, where current devices are limited due to larger insertion sizes."
The second patient was enrolled in the study by Dr. Richard Shlofmitz, Chairman of Cardiology at St. Francis Hospital and Heart Center in New York. This patient also underwent a complex, meticulous PCI involving multiple vessels, resulting in a complete revascularization of the coronary tree. Robust hemodynamic support was provided throughout the procedure and weaning from the Elevate™ system was successfully performed in the catheterization laboratory.
"As a recognized leader in cardiovascular research, St. Francis is thrilled to be a part of this study. We are excited about the prospects of the Elevate™ system given the unique combination of simplicity, attractive insertion profile, and the full hemodynamic support the pump can provide," said Dr. Shlofmitz. "In a busy practice such as ours that promotes clinical excellence with unwavering patient safety, the Elevate™ system could have a significant impact on patient outcomes."
"Magenta is proud to partner with top cardiology centers in the United States to further the validation of its technology and provide cardiologists with a powerful tool to support their high-risk patients during complex procedures," said Dr. David Israeli, CEO of Magenta Medical. "We are looking forward to a speedy recruitment process and favorable study outcomes that would allow us to take the next step in the clinical program towards ultimate market approval."
Elevate™ is an investigational device, limited by Federal law to investigational use only. The technology received Breakthrough Device Designation from the FDA for two indications: high-risk percutaneous coronary intervention and cardiogenic shock.
About Magenta Medical
Magenta Medical Ltd. is a privately-held company dedicated to the development of miniaturized blood pumps intended to provide minimally-invasive support to the native heart during acute episodes of dysfunction that could lead to dangerously low blood pressure and compromised perfusion of vital organs. Magenta's Elevate™ percutaneous left ventricular assist device (pLVAD) is currently in clinical testing, with the ultimate goal of securing approval for at least two indications: patients undergoing high-risk coronary interventions and patients with cardiogenic shock. Magenta Medical was founded by two serial entrepreneurs, Professor Ehud Schwammenthal and Mr. Yosi Tuval, who previously founded Ventor Technologies - a medical device company that was acquired by Medtronic in 2009.
SOURCE Magenta MedicalBack to HCB News