New Study: Innovative Heart Harpoon Device is Safe and Effective
Thursday, November 2, 2017
Device May Improve Quality and Frequency of Repair
Baltimore – A new study has found that a pioneering device to repair heart valves is safe and effective, and can reduce the invasiveness and side effects of conventional mitral valve surgery. The Harpoon Mitral Valve Repair System (H-MVRS), an image-guided device based on technology developed at the University of Maryland School of Medicine (UMSOM), is deployed through a small opening between the ribs, and repairs the heart while it continues to beat. The research was presented at the Transcatheter Cardiovascular Therapeutics (TCT 2017) symposium in Denver, and simultaneously published in JACC, the Journal of the American College of Cardiology.
"The Harpoon device was found to be remarkably safe and effective,” says the study’s principal investigator and an inventor of the device, James S. Gammie, MD, professor of surgery at UMSOM and chief of cardiac surgery at University of Maryland Medical Center. “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,” he says.
Thirty patients with a condition called mitral valve regurgitation (MR) were treated with the device at six clinical centers in Europe, sponsored by the manufacturer of the device, Harpoon Medical, Inc., Baltimore, Md., to determine whether the device meets essential European health and safety requirements.
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.
Click here to read the rest of the story via University of Maryland Medical Center.