Early Feasibility Trial Results Reported for Harpoon’s Mitral Valve Repair System
October 19, 2015—Harpoon Medical, Inc. recently announced clinical results of 10 patients enrolled in an early feasibility study of its repair system for mitral valve regurgitation. The results were reported by James Gammie, MD, at TCT 2015, the 27th annual Transcatheter Cardiovascular Therapeutics scientific symposium, held October 11–15 in San Francisco, California.
Harpoon enrolled 10 patients with severe degenerative mitral valve disease at two clinical centers in Poland and assessed echocardiographic results using the Core Echocardiography Lab of Massachusetts General Hospital in Boston, Massachusetts. The Harpoon system is approved for investigational use in Poland.
According to the company, key clinical highlights presented at TCT included a 100% 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 included 100% survival; no stroke, renal failure, or conversion to open heart surgery; and no blood transfusion.
In Harpoon’s press release, Dr. Gammie commented, “We were delighted to 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. The Harpoon system successfully implanted expanded polytetrafluoroethylene 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.” Dr. Gammie is Chief of Cardiac Surgery at the University of Maryland School of Medicine in Baltimore, Maryland.