Harpoon Medical has enrolled the first three patients in an early feasibility study of its repair system for the minimally invasive, beating-heart treatment of mitral regurgitation. The initial first-in-human procedures were performed at the Department of Cardiovascular Surgery and Transplantology, Jagiellonian University John Paul II Hospital in Krakow, Poland, by Krzysztof Bartus, Jerzy Sadowski, Boguslaw Kapelak, James Gammie, and Andrzej Gackowski.

“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., Harpoon Medical founder and chief of Cardiac Surgery at the University of Maryland School of Medicine in Baltimore. “Unlike the aortic valve, where 90 percent 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 [mitral regurgitation]. Only about 20 percent of patients who could benefit get open heart surgery for MR. For the remaining 80 percent, 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.”

Harpoon’s technology was developed in the division of Cardiothoracic Surgery at The University of Maryland School of Medicine. With the Harpoon device, physicians can access and repair the mitral valve in a beating heart through a small incision without the need for cardiac arrest or cardiopulmonary bypass. The device enters the left ventricle transapically and attaches neochords to the prolapsed leaflet to eliminate mitral valve regurgitation. Harpoon Medical hopes to transform traditional open heart mitral valve surgery from a complex three- to six-hour operation to a 60-minute procedure and reduce the recovery period from weeks to days, company executives contend.

“The Harpoon system worked as expected,” said 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.”

Niland and his colleagues also revealed that Harpoon won the top award in Life Sciences for the “2015 InvestMaryland” international business competition for startup and early-stage companies. The company received a $100,000 cash prize, beating out 200 competitors across four categories. The competition was sponsored by the Maryland Department of Business and Economic Development.

Based in Baltimore, Harpoon Medical is a privately held medical technology company that is developing the Harpoon system, designed to facilitate minimally invasive surgical repair and improve mitral regurgitation treatment. If left untreated, MR can lead to debilitating and life-threatening conditions such as pulmonary hypertension, arrhythmias and congestive heart failure.

Watch a video of Harpoon’s MR treatment technology below: