Behind the Design: How Abbott Built Its New TAVI System

An R&D leader at Abbott takes us behind the scenes of the company's recently approved Navitor transcatheter aortic valve implantation (TAVI) system.

Amanda Pedersen

February 13, 2023

3 Min Read
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In January, FDA approved Abbott's newest transcatheter aortic valve implantation (TAVI) system, Navitor, to treat people with severe aortic stenosis who are at high or extreme risk for open-heart surgery.

The Navitor system, which Abbott won a CE mark for in 2021, is designed with a unique fabric cuff (NaviSeal) to reduce or eliminate the backflow of blood around the valve frame known as paravalvular leak (PVL). According to Abbott, the device is also the only TAVI system designed with leaflets within the native valve. This design can help improve access to coronary arteries to facilitate future procedures for treating coronary artery disease. The company also touts excellent hemodynamics, or blood flow, through the valve. The device is implanted using Abbott's FlexNav delivery system, which features a slim design to accommodate different patient anatomies and small vessels for stable, predictable, and accurate valve delivery and placement.

Abbott's Navitor TAVI valve for transcatheter aortic valve implantation (also known as transcatheter aortic valve replacement, or TAVR)

MD+DI recently spoke with Santosh Prabhu, divisional vice president of product development, to learn more about the design considerations and challenges involved with bringing the Navitor TAVI system to market.

When Abbott set out to design the Navitor, the company knew it wanted to incorporate some of the features from the Portico valve, which was inherited through Abbott's acquisition of St. Jude Medical in 2017. But the R&D team also wanted to design some additional features, such as the NaviSeal cuff to reduce PVL.

One challenge that the NaviSeal cuff presented in the development process, however, is that it involved adding more material to the valve, which increased the profile of the valve, Prabhu explained.

"That was a constraint, we didn't want to increase the profile of the valve, we wanted to keep it the same as Portico," Prabhu said. "So, we wanted to keep the low profile, now how do we go about doing that when we're adding new material? So, we had to figure out what the material would be, and there was no off-the-shelf fabric that we could just throw into the Navitor valve to create the PVL feature. So, now we had to work on figuring out the right fibers for this material the right weave pattern that will give us that low profile."

The team realized they had to make the material really thin, while also making sure the material was also durable enough.

"So, we had to come up with multiple different choices, do a lot of evaluation to make sure we had the right fabric, the right material, and of course, it has to function in reducing PVL too," Prabhu said. "So, those are some of the design considerations that we had to make."

In conjunction with all the design work, the team also had to test the device and develop all the right testing methods, which requires a lot of effort. Not only that, but the team was also working on the FlexNav delivery system for the Navitor valve, Prabhu explained.

"Now, we had to make sure that the valve we are designing marries well with the delivery system," he said. "So, as you can see, there were a lot of early learnings during the course of the product development program, but at the end of the day I think we ... overcame all those challenges that we encountered."

When asked what part of the design process was most fun to work on, Prabhu said it was the whole process of figuring out what features needed to be incorporated into the system and making several different design iterations before landing on the right one.

"I wouldn't say there's one exciting part, it was the whole journey that got us really excited," he said.

About the Author(s)

Amanda Pedersen

Amanda Pedersen is a veteran journalist and award-winning columnist with a passion for helping medical device professionals connect the dots between the medtech news of the day and the bigger picture. She has been covering the medtech industry since 2006.

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