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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Today’s #VeteranOfTheDay is Women’s Army Corps Veteran Martha Settle Putney. Martha served during World War II. Born and raised in Norristown, Pennsylvania, Martha had been determined from a young age to earn a college degree. In 1935, Martha had earned enough money to attend a year of college at Howard University. While attending, Martha was recruited by a congressional candidate to garner votes from the black community, and in return, was given a full scholarship to continue her education. She ultimately graduated from Howard University with a bachelor’s degree in History and a master’s degree in Modern European History. After completing college, Martha applied to work in the district school system, but lacked the personal connections to get the job. Instead, she applied for a position with the War Manpower Commission and received a job as an assistant stockroom clerk. After spending time with the War Manpower Commission, Martha became aware of the newly formed Women’s Army Corps and decided to take the Army General Classification Test. Having done well on the test, Martha was invited to formally enroll with the Women’s Army Corps and after enlisting, was sent to Fort Des Moines, Iowa. There, she received basic training and adjusted to working in a military which was still largely segregated. Following basic training, Martha was assigned to administration school and later officer candidate school. On July 7, 1943, Martha completed her training and two months later was assigned as a supply officer, responsible for maintaining provisions. While working as a supply officer, Martha applied for and was accepted to adjutant general school at Fort Sam Houston, Texas. After completing adjutant general school, Martha was assigned as a troop commander at the Army Air Force Base in Midland, Texas before being sent back to Fort Des Moines, where she worked with the special training units. While there, Martha used her position to effectively desegregate the pool at Fort Des Moines. From Fort Des Moines, Martha was sent to Chicago, Illinois, where she served as a commanding officer of a hospital company. She remained in this position throughout the war until the company was decommissioned in July 1946. After leaving Chicago, Martha was assigned to Fort Custer, Michigan before being granted a transfer to Fort Wadsworth in Staten Island, New York. Martha was discharged from the Women’s Army Corps in 1946 at the rank of first lieutenant. Following her discharge, Martha used her benefits under the G.I. Bill to enroll in the doctoral program at the University of Pennsylvania, ultimately earning a PhD in European History. She went on to achieve notoriety for her contributions to the civil rights movement and her work chronicling the history of African American service members. Martha passed on Dec. 11, 2008 at the age of 92. We honor her service.
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