According to the Centers for Disease Control (CDC), nearly six million people in the United States are suffering from heart failure, and about half of those people will die within five years of their initial diagnosis. It’s a $35 billion annual problem that, until recently, has had very little innovation in how it is addressed. Alleviant Medical, however, is taking a novel approach to treating heart failure.
According to Jacob Kriegel, MD, CEO of Alleviant Medical, today’s treatment options are focused either on making the heart pump more efficiently or treating the fluid accumulation that results from the failing heart pump. Pulmonary fluid buildup, the primary driver of heart failure symptoms, leads to shortness of breath, swelling, general weakness, and a host of other problems. Diuretics are usually prescribed to treat these symptoms, but Dr. Kriegel and his team are addressing the underlying cause of pressure buildup within the left atrium.
Heart failure is a progressive condition in which the heart muscle is unable to pump or fill adequately with blood during and between heartbeats. As a result, pressure builds within the left atrium and backs up to the lungs, leading to fluid accumulation and severe symptoms. Only recently have practitioners begun to focus on elevated left atrial pressure as a potential intervention point, being that it is one of the earliest signs of heart failure exacerbations.
Alleviant Medical is focused on relieving pressure within the left atrium. In layman’s terms, they are developing a minimally invasive device that bores a hole (termed an interatrial shunt) between the left and right atrium, allowing for left atrial pressure offloading to the low-pressure right atrium. While Alleviant Medical is not the first company to propose interatrial shunting as a novel form of treatment, their approach does not necessitate the implantation of a foreign body to do so. This affords a lower risk profile, as well as a shorter regulatory pathway; as a result, their device is eligible for FDA 510(k) clearance as a Class II medical device.
Interestingly, one of the insights for their approach came from studying the small percentage of the population born with a larger hole between the left and right atrium. While some patients have to undergo surgery to have the issue resolved, those who don’t have their defect closed seem to be naturally protected from some of the symptoms of heart failure. According to Dr. Kriegel, “We know from those patients what shunt size is appropriate as well as other concerns that we need to monitor in potential recipients of our treatment.”
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Image Credit: Alleviant Medical