To correct high blood pressure of the pulmonary artery, which can arise from congenital defects of the heart, an artificial heart ucan cost upwards of $190,000. Heart disease accounted for about one in five deaths in 2020 in theUnited States.
Even minimally invasive pulmonary artery banding — a surgical technique that has been in use since Harry Truman was president — requires access to the chest cavity.
A new treatment under development by HeartPoint Global seeks to provide a minimally invasive alternative. A device delivered through the leg would cost only $4,000, according to Seth Bogner, the Florida-based company’s CEO. The company expects to start human trials this year.
Bogner claims his company’s device, Intellistent, previously known as Influunti, would be an affordable treatment for pulmonary artery hypertension. Current treatments — an artificial heart, pulmonary artery banding — are costly, and oftentimes unfeasible because of lack of infrastructure or available specialists.
“Our approach is to gradually reduce flow and pressure in the pulmonary artery,” Bogner said. “We can go ahead and do it all in one step, based on our algorithm, and we can also adjust it. We can see if the adjustment is okay, come back in a week, a month, or a year … but [the patient] never has to suffer a big reduction.”
Intellistent can gradually reduce the flow of pressure by nesting stents within the pulmonary artery or its branches. Its algorithm provides a baseline for how much to reduce the pressure.
The Pulmonary Artery Banding procedure, which HeartPoint Global is aiming to provide an alternative for, has been practiced since 1951, when surgeons performed the first such procedure on a five-month old infant with a heart defect. The procedure’s use has declined in recent years, but is still in the arsenal of treatment for complex congenital heart defects, Mayo Clinic researchers wrote in 2022.
To conduct the banding, a surgeon must gain access to the main pulmonary artery by making an incision between the second and third, or third and fourth, ribs, or via a vertical incision in the sternum. Pulmonary Artery Banding is sometimes preceded by the phrase “minimally invasive.” But minimally invasive is relative. Researchers at the All India Institute of Medical Sciences in New Delhi developed a minimally invasive method, but it still requires opening the sternum. Their technique, involved using a smaller split to pry open the sternum and gain access to the artery for banding.
Even while less invasive than conventional methods, this process still requires access to the chest cavity. And that is where HeartPoint Global seeks to provide a distinct point of difference using a different route to delivering the device. It is inserted through the leg to go into the pulmonary artery and its branches.
Choosing the right amount of constriction for pulmonary artery banding can be a bit of a guessing game, and to make subsequent adjustments, the procedure must be repeated. Intellistent can be repeatedly tweaked to find the right pressure using a series of nested stents, Bogner explained. He conceded that “no algorithm in the world can predict the correct pressure,” — and that would include the one that HeartPoint Global’s own algorithm. However, the company hopes to also develop a smartphone app to monitor the pressure and facilitate adjustments.
Besides pulmonary artery banding, the National Health Service lists anticoagulants, diuretics, oxygen treatment and digoxin as treatments for the effects of PAH. Other treatments, which seek to slow or potentially reverse the condition, include endothelin receptor antagonists, phosphodiesterase 5 inhibitors, prostaglandins, soluble guanylate cyclase stimulators and calcium channel blockers.
Those medical treatments are “palliative,” according to Paul Vogt, the former director of the Cardiac Surgery Department at the University Hospital Zurich, who now heads up HeartPoint Global’s Medical Advisory Board. “Only Intellistent, which will be replacing pulmonary artery banding and decreasing pulmonary overflow with subsequent correction of the underlying heart disease, is curative.”
“No other device” treats pulmonary artery hypertension, Bogner said. “There is no effective treatment for pulmonary artery hypertension.”
Systemic blood pressure represents the force of a person’s blood moving through the blood vessels overall in the body and high blood pressure in this context means pressure is high in the arteries throughout. By contrast, pulmonary blood pressure is the pressure the heart exerts to pump blood from that organ through the arteries of the lungs and hypertension there means high blood pressure in the lung arteries.
HeartPoint Global must surmount a number of obstacles before potentially getting a nod from the FDA, not least of which is conducting human trials.
That’s because conducting a human study with the novel device requires HeartPoint to produce those devices on a regular cadence. That has posed a problem, Bogner said, because of supply chain woes.
“What used to take three weeks sometimes takes six months,” Bogner said.
One component that Bogner said had been particularly challenging to obtain is synthetic teflon, which HeartPoint uses to line the shafts of its device. But Bogner said the company ultimately tracked down the elusive non-stick polymer.So far, the company has manufactured its device in Israel. Bogner said the company plans to expand its manufacturing to the United States and Europe.
As for human trials, HeartPoint had elected to conduct human trials in Kyiv, where it had already initiated the patient selection process. But that progress hit a snag when Russia invaded Ukraine in early 2022, forcing the medical devices company to move its operations out of the country.
“Along with 200 other companies doing medical testing in Ukraine,” Bogner said, “HeartPoint became another casualty of the war.”
The company is in the process of signing agreements for human trials in Western Europe Bogner said. HeartPoint Global has conducted three rounds of preclinical testing, and hopes to announce a human study by the end of the year.
After the clinical trial, HeartPoint hopes to petition for breakthrough device designation from the FDA, by which the agency expedites the development, assessment and review of novel treatments. The agency has been more amenable to assign breakthrough status in recent years. FDA bestowed breakthrough status on just 55 devices in 2018, but greenlit 164 in 2022. Cardiovascular devices — HeartPoint’s device falls under this category — represent the largest category of breakthrough devices.
Having completed three rounds of preclinical testing, Bogner is optimistic about human trials.
“We’re pretty certain we won’t have any bad surprises,” he said.