Abbott enters TAVI device market dominated by Edwards, Medtronic - MedCity News

Abbott is now entering a corner of the medical device space that has been dominated by Edwards Lifesciences and Medtronic. On Tuesday, the company won FDA approval for its newest transcatheter aortic valve implantation (TAVI) system, which is called Navitor. The product received CE marking and entered the European market in 2021.

Navitor is designed to treat people with aortic stenosis who are at high risk of open heart surgery. Aortic stenosis is a condition in which the opening of the aortic valve narrows, leading to restriction of blood flow from the body. Open-heart surgery is an option for some people with the condition, but those with severe cases of the disease face potential complications, usually due to age or co-morbidities.

The need for minimally invasive products to treat aortic stenosis is more urgent than ever — the condition is expected to double in Europe and the U.S. over the next few decades as the world’s population continues to age, said Michael Dale, senior vice president of structure at Abbott cardiac business.

The space Abbott is entering is basically a duopoly, as TAVI systems made by Edwards and Medtronic have a firm grip on market share. Boston Scientific emerged as a contender in 2019 when it won FDA approval for its transcatheter aortic valve replacement system, but the company terminated the product after only being on the market for a little over a year. There are also startups that have not yet won the FDA approval needed to enter the commercial market, such as JenaValve.

Now that Abbott has been approved to sell its TAVI system in the US, the company is aiming to become a respected third-party player in the market. So what will make Navitor stand out from the traditional?

Dale pointed out several distinguishing factors. First, Navitor is implanted using Abbott’s delivery system, which features a slim design to accommodate different patient anatomies for reliable delivery and placement of the valve. The device also has a unique fabric cuff designed to limit backflow of blood, he said.

“The latest generation Navitor device is the only self-expanding TAVI system with sails in the native valve and offers other improvements, including the NaviSeal smart cuff, which actively synchronizes with the cardiac cycle to close off backflow of blood around the valve frame,” – Dale said. “Also, Navitor is the first TAVI system to offer optimal hemodynamics across all valve sizes, which also preserves options for any future disease management, benefiting both physicians and patients.”

Time will tell if Abbott will become a formidable rival to Edwards and Medtronic in the US market for TAVI systems. In Europe, Abbott has a “mid-teens share” of the market, analysts at RBC Capital Markets said MedTech Dive.

Photo: Abbott

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