Novel Medical Device Provides Custom, Cost-Effective Solution for Atrial Fibrillation Patients

Professor Atman Shah worked with the Polsky Center for Entrepreneurship and Innovation to develop a prototype of a medical device for treating atrial fibrillation.

Founded by an interventional cardiologist at the University of Chicago, Parasol has developed a novel, minimally invasive device to reduce the risk of stroke in patients with atrial fibrillation.

At the University of Chicago, Atman Shah holds the titles of professor of medicine, clinical director of cardiology, and co-director of the cardiac catheterization laboratory, in addition to his work as an interventional cardiologist. He’s also a founder. His startup, Parasol, has developed a catheter that delivers a gel seal to protect atrial fibrillation patients against stroke.

The device is the result of his experiences as a physician, a role in which he takes care of patients with holes in their hearts, who have valve problems, or who need a procedure to address a problem with the architecture of their heart. Working with patients has been “absolutely critical” to his research path, which is focused on improving survival rates in cardiac arrest or an acute myocardial infarction (heart attack).

“I love the focus on curiosity and inquisitiveness and the support the institution gives to answer questions,” said Shah, speaking to his time at UChicago where he has been working since 2009.

“I love working with patients,” he added, “It’s the ability to cone down years of research and expertise to take care of one person’s life. Each person is different, and I love trying to figure out the best way to take care of the individual patient. That has allowed me to continue to question current treatments, strategies, and the willingness to be wrong, but to keep asking.”

Asking these questions led him down the path of founding Parasol – the French word for umbrella, the shape of which is seen while the device is in use.

The main feature of the device is to cover the left atrial appendage while the gel is injected, like an umbrella.

Approximately 40 million Americans experience an irregular heart rhythm, or atrial fibrillation, which can lead to strokes forming in the left atrial appendage, a small extension of the heart’s upper left chamber. Treatment often includes blood thinners, though many patients with atrial fibrillation are older, or work in occupations where taking a blood thinner can increase their risk of bleeding, explained Shah.

Currently, two available devices are approved to seal the left atrial appendage, but both are metallic, require active fixation, and are not custom-fit. The appendages “are like snowflakes,” he said, “so many patients are not truly protected against stroke.”

To solve for this, Shah’s idea was to create a catheter that delivers a gel for a custom-designed, non-traumatic way to seal the left atrial appendage and protect patients against stroke. The gel – which is already commercially available, shortening the regulatory pathway to approval – hardens and will fit like a mold.

Shah has developed a prototype after receiving a proof-of-concept grant from UChicago’s Polsky Center for Entrepreneurship and Innovation and Biological Sciences Division. He also worked with the Polsky Center to translate his initial ideas into a CAD model and connect with a manufacturer.

The novel device has several advantages over currently available options, which are round and don’t always fit a noncircular appendage, “Parasol takes care of that,” said Shah. Current options also rely on active fixation, which can rip the thin-walled appendage, a problem that doesn’t exist with the gel delivery of Parasol’s device.

Additionally, existing devices “are not custom made, so the depth of the left atrial appendage may cause the device to sit too deep, or not deep enough, and result in clots on the device, or leaks around the device, leading to stroke,” Shah explained. “Parasol doesn’t have that.”

Parasol’s device will also be one-third the cost of currently available options.

As part of the process in developing Parasol, Shah in fall 2024 participated in the Polsky Center’s I-Corps program after which he went on to the National program.

The experience was “absolutely fantastic,” he said. “It was a great introduction into the world of entrepreneurship and offered incredible opportunities to connect with other like-minded individuals. The idea of questioning everything now, instead of later, and being curious has been humbling and helpful. It also allowed me to start thinking long term about who would have a role with my company and what next steps to take.”

As for next steps, Shah is looking to further test the device on the bench and then in animals – and secure additional funding to support development.