New Innovations in Treatment of PE: The Flow Medical Story

Dr. Paul, interventional cardiologist, begins by explaining how he and Dr. Ahmed, interventional radiologist, came to work together. Dr. Ahmed came to the University of Chicago shortly after Dr. Paul started a pulmonary embolism response team (PERT) program. Dr. Ahmed, through his IR training, had experience with PE/VTE. They met and decided to combine their knowledge to build the program together. They both saw a need for new catheter directed thrombolytic (CDT) devices in their respective fields. The landscape of thrombectomy device innovation was booming, but they did not see the same innovation happening for CDT.

After they both received the COVID vaccine, they were eating at Panera and drew out the idea for their device on a napkin. Neither of them had prior engineering experience and didn’t know how to proceed after this, so they relied on the University of Chicago’s entrepreneurial programs as a starting place. They then did market research and used their own internal research funding to subcontract with an engineering firm. They have been working on the design prototype since, and are conducting animal studies to trial the device. Once they reach design freeze, they will start the regulatory process and NIH 510(k) submission. They also have an NIH SBIR grant for small businesses doing innovative research. They plan to have the device on market in mid 2024.

The goal for their device is to make it a catheter that can provide real-time feedback to minimize the complications of both too little or too much thrombolytic therapy. They are installing a sensor on the device that displays how much of the clot is lysed and allows for personalized PE treatment. They hope to incorporate AI into their data management, which they will use to tailor treatment in future patients.