Minimally invasive Mitral Valve repair specialist Harpoon Medical has enrolled the initial three patients in an Early Feasibility Study of its repair system for the minimally invasive, beating-heart treatment of Mitral Regurgitation.
Background
Mitral regurgitation (“MR”), is the most common type of heart valve disease. If left untreated, MR can lead to debilitating and life-threatening conditions such as pulmonary hypertension, arrhythmias and congestive heart failure.
We’ve covered one solution, Abbott’s MitraClip, extensively in the recent times, this being one method of limiting the amount of MR permitted by a failing Mitral Valve. Harpoon Medical’s system adopts a different approach. In case you hadn’t come across the company before, it is developing a clever minimally invasive system to capture and constrain a failing mitral valve leaflet. As the name suggests, the device effectively harpoons the leaflet from the left ventricular access point and then anchors it using a buttress on the outside of the ventricular wall, acting somewhat like a new chord.
The initial first-in-human procedures were performed at the Department of Cardiovascular Surgery and Transplantology, Jagiellonian University John Paul II Hospital, by the team of Krzysztof Bartus, Jerzy Sadowski, Boguslaw Kapelak, James Gammie, and Andrzej Gackowski.
Company comments
“While our ultimate goal is to demonstrate long-term durability of the Harpoon system, the fact is that major problems are most likely to occur in the first 30 to 60 days, and therefore we are extremely pleased by the strong clinical results to date with the initial three patients,” said James Gammie, M.D., founder of Harpoon Medical and Chief of Cardiac Surgery, University of Maryland School of Medicine.
“Unlike the aortic valve, where 90% of patients suffer from aortic stenosis and replacement is the preferred treatment option over open surgery, mitral valve disease has multiple etiologies, and repair is preferred over replacement to treat primary MR,” added Dr. Gammie. “Only about 20% of patients who could benefit get open heart surgery for MR. For the remaining 80%, there is a compelling need for less-invasive mitral repair technologies. Our system is designed to change this unacceptable situation for patients suffering from MR.”
“The Harpoon system worked as expected,” added Bill Niland, CEO of Harpoon Medical. “The investigator was able to quickly and easily navigate to the desired location and deploy the Harpoon system’s neochords, which are designed to be easy to deliver and secured by a superior anchoring approach. We are very pleased with our clinical results thus far.
Source: Business Wire
