New Study: Innovative Heart Device is Safe and Effective
James S. Gammie, MD, professor of surgery at the University of Maryland School of Medicine, chief of cardiac surgery at the University of Maryland Medical Center and world-renowned mitral valve repair expert, discusses a new study that found the Harpoon Mitral Valve Repair System (H-MVRS), a novel investigational device, was safe and effective in treatment of degenerative MR, the most common type of heart valve disorder.
Thirty MR patients were treated with the device at six clinical centers in Europe, sponsored by the manufacturer of the device, Harpoon Medical, Inc. (Edwards Lifesciences), to determine whether the device meets essential European health and safety requirements.
"The device allowed the surgeons to precisely and effectively reduce the degree of mitral regurgitation without using an open-heart procedure. There were no deaths. Only one patient needed a blood transfusion, and there were no strokes, no need for pacemakers, no readmission to the ICU, and no reintubations," says the study's principal investigator and an inventor of the device, Dr. Gammie.
Three patients required conversion to conventional open-heart mitral surgery, including two cases where poor imaging prevented accurate placement of the tool, while 27 met the primary endpoint. At six months, MR was mild or less in 85 percent (22/26) of patients successfully treated with H-MVRS. The repair was associated with restoration of normal valve function and improvement in the heart's ability to pump blood, according to the researchers, and the operative times for procedures using the device were approximately half those reported for conventional mitral valve repair.
"Over the past five years, our faculty has increasingly engaged in entrepreneurial and technology transfer activity – with significant increases in the number of U.S. and foreign patents issued, technology inventions licensed and start-up companies formed," says UMSOM Dean E. Albert Reece, MD, PhD, MBA, vice president for medical affairs at the University of Maryland and the John Z. and Akiko K. Bowers Distinguished Professor. "This invention by Dr. Gammie is an excellent example of how new devices and therapies developed here have tremendous potential for treating patients and ultimately saving lives."
The H-MVRS is an investigational device. It has European CE marking and is now commercially available in Europe. The device was previously tested in Poland. U.S. testing of the device may begin in 2018.
DISCLOSURE: The study was funded by Harpoon Medical, Inc. Dr. Gammie and three others on the research team report ownership of stock and/or options to purchase stock in Harpoon Medical. At the present time, the US Food and Drug Administration has not approved the H-MVRS for patients in the United States.
Learn more about University of Maryland Heart and Vascular Center's Mitral Valve Program.