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Israeli Medtech company revolutionizes monitoring of dialysis patients for life-threatening fistula blood clots

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PatenSee’s imaging system is heading to its first clinical trials in Israel, which will be run by Prof. Benaya Rozen-Zvi, director of the Institute for Nephrology and Hypertension at Rabin Medical Center

By ILANIT CHERNICK

An Israeli Medtech company is on its way to revolutionizing the way in which millions of dialysis patients are monitored for asymptomatic stenosis.

Founded in 2019, PatenSee, has developed a “robust way to check that the dialysis access point in patients remains open” so that they “have an improved quality of care and prolonged life expectancy.”

Dialysis is a process of purifying the blood of a person whose kidneys are not working normally. PatenSee CEO Gal Goshen told IsraelNewsStand that asymptomatic stenosis occurs when the access point for dialysis, known as a fistula, becomes blocked but the patient shows no symptoms and is unaware of any problems.

“Due to the need for a strong blood flow and repeated access for dialysis, a fistula is created surgically as it is easier to puncture and to obtain the needed blood flow versus accessing an artery or vein,” he explained. “However, as it is not a natural structure and is regularly punctured, it is almost certain that it will become blocked at some point.”
According to Goshen, a healthy or open fistula has a 20-30% chance of developing stenosis at some point every year. 

However, he said, “a high-risk fistula that has already undergone interventions has an even higher chance of stenosis every year – 40-60%.”

“Asymptomatic stenosis is when the fistula becomes blocked without a patient exhibiting symptoms and therefore will be unaware that there is an issue,” Goshen said. “As mentioned above, fistula stenosis above 50% blocked, becomes symptomatic, harder to be opened and can result in a blood clot or thrombosis, which are often life-threatening.”

Goshen pointed out that stenosis is usually discovered by nurses through physical examinations because it has become symptomatic.

“However, nurses do not always have time to perform these thorough examinations, and often, when stenosis is discovered, the fistula is already at least 50 percent blocked and at risk of causing clots or thrombosis,” he explained. 

What PatenSee’s imaging system aims to do is aid nurses and predict developing asymptomatic stenosis at an early stage. 

“With this early detection, clinical teams can perform simple interventions to maintain the integrity of the fistula for hemodialysis,” Goshen said.

Asked how it works, Goshen told IsraelNewsStand that the system captures images of the fistula over time with three different imaging modalities.
“This ‘3in1’ imaging technology collects different parameters that correlate with the ‘Look, Listen & Feel’ physical examination usually performed by nurses,” he emphasized. “When analyzed over time, using machine learning technologies, PatenSee can objectively identify evolving fistula stenosis risk.”

The imaging system is heading to its first clinical trials in Israel, which will be run by Prof. Benaya Rozen-Zvi, director of the Institute for Nephrology and Hypertension at Rabin Medical Center. It will evaluate the system’s ability to perform contact-free surveillance of fistula stenosis similar to a nurse’s physical exam of hemodialysis patients.

“At least 120 patients will be part of this specific study which will evaluate the system’s ability to perform contact-free surveillance of fistula stenosis,” Goshen said. “It will also collect usability information to demonstrate how the process integrates into the clinical workflow.” 

He added that the study will then be expanded to community hemodialysis centers both in Israel and abroad.

Asked what 2021 has in store for PatenSee, Goshen said that following this study the company hopes “to begin work on the next generation of our system.” 

“[It] will be smaller and more suited to home use in order to aid nurses and hemodialysis patients in early detection of asymptomatic fistula stenosis in a home care environment,” he concluded.

*Featured Image: The PatenSee imaging device used to detect asymptomatic stenosis. (Photo Credit: Supplied)

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