Harpoon Medical reports results of ten patient early feasibility trial of its repair system for off-pump, minimally invasive treatment of mitral valve regurgitation ("MR")
Outstanding clinical results reported at 2015 Transcatheter Therapeutics Conference in San Francisco
BALTIMORE, Oct. 15, 2015 /PRNewswire/ -- Harpoon Medical, Inc. a medical device company focused on minimally invasive mitral valve repair, announced that it has presented clinical results of ten patients enrolled in an Early Feasibility Study of its repair system for the minimally invasive, beating-heart treatment of MR. The results were reported by Dr. James Gammie, Chief of Cardiac Surgery at the University of Maryland School of Medicine, at the 2015 Transcatheter Therapeutics Conference in San Francisco. Harpoon enrolled ten patients with severe degenerative mitral valve disease at two clinical centers in Poland and assessed echocardiographic results using the Massachusetts General Hospital's Core Echocardiography Lab.
Key clinical highlights included a 100 percent procedural success rate, reduction of mitral regurgitation to mild or less in all patients, brief procedure times, and two patients with 6-month echocardiographic follow up, both with stable mitral valve repairs and no mitral regurgitation. The safety profile was outstanding, with 100 % survival, no stroke, renal failure, conversion to open heart surgery, and no blood transfusion.
"We were delighted share the mounting clinical evidence that the Harpoon technology enables true minimally invasive mitral valve repair on the beating heart, avoiding cardiopulmonary bypass, cardiac arrest, and conventional open heart surgery," said Dr. Gammie. "The Harpoon system successfully implanted ePTFE neochords on the diseased mitral valve leaflets and restored normal mitral valve function. This beating-heart, image-guided minimally invasive approach has great potential to alter the therapeutic landscape for mitral regurgitation."
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About Harpoon Medical
Based in Baltimore, Harpoon Medical is a privately held medical device company developing technology designed to facilitate minimally-invasive, beating-heart mitral valve repair to transform the treatment of mitral regurgitation ("MR"). The Harpoon device eliminates the need to divide the breastbone, put the patient on a heart-lung machine and stop the heart. The technology will transform conventional mitral valve surgery from a complex 3-6 hour operation to a sixty minute procedure that allows a patient to return to normal daily activities within a week.
CAUTION: The Harpoon system is approved for investigational use in Poland.
SOURCE Harpoon Medical, Inc.
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