Cutting a hole in the heart to treat congestive heart failure may sound counterintuitive, but a Texas Medical Center (TMC) startup company hopes to do just that.
Alleviant Medical is developing a transcatheter device to treat diastolic heart failure, which occurs when one or both of the ventricles do not fill up properly with blood and are unable to pump enough blood to the rest of the body.
The device will enter the body near the groin, travel through the body via the femoral vein, and then gain access to the heart. At that point, an expandable blade will cut a hole in the wall separating the left and right atria. The blade and tissue will be pulled back into the device, which will then be removed.
This hole will help blood flow from the left chamber to the right chamber of the heart.
Over the past 20 years or so, medical devices, treatments and drugs have helped people with heart disease, but there are few options for people suffering from heart failure, said Jacob Kriegel, M.D., co-founder and CEO of Alleviant Medical.
“It’s a very morbid condition, so it rose to the top of the list as an important unmet need,” Kriegel said.
Kriegel and his colleagues, Alex Arevalos, Ph.D., Albertien Greijdanus, MSc, and Avni Patel, M.E., examined several hundred unmet needs as part of TMC Biodesign, a one-year fellowship program that gathers people with diverse backgrounds to solve health care problems via medical devices or digital products.
“As a cardiac surgery trainee, I had seen hundreds of heart failure patients, but for me, it took sitting down with engineers to see the problem through new eyes,” Kriegel said. “Our perspectives merged with market opportunity.”
Kriegel and his colleagues understand that creating a hole in the heart comes with risk. But if the hole is precisely sized, it can distribute the correct amount of pressure from the left atrial to the right atrial without dramatically increasing the right-sided pressure—a therapeutic benefit while minimizing risk. The hole will allow blood to flow naturally from the left chamber to the right chamber, lowering the pressure on the left and slightly increasing the pressure on the right, where it is already low, Kriegel said.
With every heartbeat, it is expected that 30 percent of the blood in the left atrium will transfer into the right atrium, and the remaining 70 percent will get pumped forward along its natural pathway into the left ventricle and out to the body, he added. The blood that gets sent into the right atrium will travel to the lungs and then continue along through the normal circulation.
A hole may drastically improve quality of life for older patients, keeping them independent and out of the hospital.
“The hole we create will be the least of their problems, and we believe it will alleviate their symptoms,” Kriegel said.
Current treatments for heart failure include a diuretic, or water pill, but that medication has side effects that include kidney failure. Other treatment options include inserting a stent—an expandable mesh tube, usually made of stainless steel—to create a passageway between the left and right atria that allows blood to flow more freely. But all implantable devices come with the risk of blood clots—which can grow around the device—and stroke.
Alleviant Medical’s device packs the severed tissue down inside the device and removes it safely from the body. That’s important, because any particle or foreign material left can flow into the brain and cause a stroke, Kriegel said.
Though the company is less than a year old, it has gained traction in the business plan competition circuit. Already, Alleviant Medical has won challenges at Rice University and the University of Massachusetts. The team plans to continue at the Texas Medical Center, joining the upcoming TMCx medical device accelerator.
“These competitions have been good learning experiences for us because we have received validation on our device,” Kriegel said. “We’ve been able to see where our risks are, where we have proven the technology and what people are concerned about. Overall, we hear good things, and that people are looking for a new solution to the problem.”
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