A very small clip inserted directly into the heart prevents leakage of blood caused by a valve that fails to close properly, thereby preventing potential serious health problems.
The mitral valve opens between two of the four chambers of the heart, regulating the flow of blood from the left atrium into the left ventricle below.
But, LifeCord CEO Yaron David tells NoCamels, in many cases, the flaps of the valve do not close properly and blood flows back into the left atrium, a phenomenon called mitral regurgitation. This puts strain on the heart, forcing it to work harder and eventually causing health issues that can lead to cardiac arrest and even stroke.
“Two percent of the world population has mitral regurgitation, and it’s a problem that increases with age,” says David.
This increase in occurrence with age, he explains, means that 10 percent of people aged 75 and above will experience mitral regurgitation.
As the heart beats, the two mitral valve flaps (known as leaflets) are opened and closed, guided by twin sets of chords that are anchored to the leaflets at the top and to the left ventricle at the bottom.
In around half of cases, the leaflets are misaligned due to the lengthening or even tearing of the chords over time, usually for only one of the flaps and not both.
David, a mechanical and biomedical engineer with more than a decade of experience in the field of medical devices, compares the chords to the strings on a parachute, which cannot function properly when one of the strings is torn or out of sync with the others.
LifeCord’s implants are placed in the same location as the chords and effectively replace them in the functioning of the mitral valve. The implant pulls the affected leaflets back into alignment, ensuring that the valve closes fully and any leakage of blood is halted.
The implant is inserted using a catheter via a blood vessel that is accessed from the groin, and avoid majorly invasive steps.
“We didn’t invent anything,” David says of the catheterization process. “This is the way they put in stents and heart valves. This was important to us because we didn’t want to invent a new delivery method.”
The implants are made from nitinol, an alloy of nickel and titanium, which David says makes them extremely durable.
“Nitinol is a cool material used in stents,” he explains. “It is actually a shape memory alloy and an elastic material. So if you open it a little and then close it, it’s going to stay closed on the leaflet, with no problem, for years and years.”
The devices are gently clipped at one end onto the leaflet without harming it, and anchored at the other end onto the thick ventricular wall below, beating in time with the heart and effectively taking over the job of the chords.
And because they are only clipped onto the leaflets without sutures, the devices can be moved to a more effective position without any harm to the delicate tissue and can allow for future interventions – such as actual valve replacement – to take place.
At present, the most common solution for the disorder is open heart surgery, which David calls “a very complicated” treatment.
Open heart surgery requires hospitalization for twice as long as the catherization process of the LifeCord solution and has a further recovery period of up to eight weeks. And, unlike the catheterization, the heart is stopped for open heart surgery and the patient placed on a cardiopulmonary bypass machine.
David explains that aside from the inherent dangers of such invasive surgery, the procedure involves placing a suture the leaflet itself to the ventricular wall, damaging the delicate flaps that are less than half a millimeter thick.
“If you try to suture a small leaflet, it’s not going to be the same,” he says. “After you finish with it, it’s not going to look the same.”
The lesser invasive procedure used by LifeCord also means a shorter recuperation period in hospital, of just two to three days, primarily for monitoring the patient.
LifeCord is part of the MEDX Xelerator incubator, and is based at its site in the central city of Or Yehuda. The idea for the clips actually came about as a result of collaboration between the Israeli startup, an unnamed American MEDX strategic partner and Mayo Clinic, the top-ranked hospital in the United States.
Both of the American institutions are today also investors in LifeCord, along with the Israel Innovation Authority, the branch of government dedicated to promoting the nation’s high-tech sector.
The company is on the cusp of its first human trials, which are set to take place in Europe, and David believes it will be on the market in around five years.
“I feel it’s a very good project,” he says. “Every physician I talked to said that it’s a big problem but they are not comfortable performing open heart surgery on a 75-year-old. So to me, it’s a blessing.”
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