Orqis(R) Medical Completes First in Man Implant of Revolutionary Exeleras Product
LAKE FOREST, Calif., Sept. 15 /PRNewswire/ — Orqis(R) Medical Corporation announced the first implant of the new Exeleras System in a 47 year old man suffering from NYHA Class III heart failure. The man was a moderately severe heart failure patient who, without the Exeleras device, would need to decline significantly to be considered a candidate for a more invasive ventricular assist device procedure. Within 48 hours of the minimally invasive Exeleras procedure being performed, the hemodynamics shifted from being classified as ‘moderately severe’ heart failure to near normal levels.
Exeleras is the first of its kind minimally invasive device that was successfully placed via a subcutaneous procedure in a hybrid cardiac interventional suite at Universitatsklinikum Essen, Germany. The device placement does not require a traditional operating room nor does it require the patient to undergo the hardship of an open-chest procedure. Ken Charhut, President and CEO commented, “Exeleras is well poised to provide long-term Aortic Flow Therapy to address the treatment gap where over 4 million NYHA Class III heart failure patients worldwide find themselves today. The success of the long-term Exeleras System, coupled with our short-term Cancion product, will enable physicians around the world to employ low-risk Aortic Flow Therapy to treat heart failure patients. This adoption will propel the company’s growth.
Dr Steven F. Bolling, Professor of Cardiac Surgery, University of Michigan was present for the procedure and added, “This is a transformational therapy with an easy to perform procedure which promises to provide a viable long-term solution to the large number of Class III heart failure patients who are far upstream of the disease progression that is typically associated with more invasive ventricular assist devices.” Dr Reynolds Delgado III, Medical Director, Mechanical Assist Devices in Heart Failure, Texas Heart Institute, contributed, “The procedure performed in Essen well-demonstrated the feasibility and hemodynamic efficacy of Aortic Flow Therapy with the Exeleras System in a patient who exemplifies the large number of patients who would directly benefit from this less-invasive approach.”
The first set of patients will be implanted with the Exeleras System to evaluate the short-term safety and performance attributes of the device. “The success of our initial clinical evaluations will allow us to best define the clinical protocols to properly study the potential long-term effect and benefit offered by this exciting new therapy,” stated Marvin Konstam, M.D. Medical Director, Orqis Medical, and Professor of Medicine, Tufts University.
About Heart Failure
Over 5 million Americans suffer from heart failure, a condition in which the heart becomes weakened and cannot pump blood efficiently. In the U.S., heart failure results in over 1 million hospitalizations annually and is responsible for over $33 billion in direct and indirect costs to the U.S. healthcare system each year.
About Orqis Medical Corporation
Orqis Medical Corporation is a privately held medical device company that develops and sells minimally invasive devices that unload the heart without touching the heart and improve cardiac performance. Orqis devices enable Aortic Flow Therapy to provide a low-risk treatment option for patients not responsive to optimal medical management but also not suitable candidates for more invasive procedures. The percutaneous Cancion product has secured the CE mark. The implantable Exeleras(R) System is in clinical development. For more information on Orqis Medical, please visit http://www.orqis.com/
Note: Orqis(R), Cancion(R), and Exeleras(R) are registered trademarks of Orqis Medical Corporation.
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Orqis Medical Corporation
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