Benzinga | May 17, 2021 04:59PM EDT

Abbott's Navitor Aortic Heart Valve Replacement Scores European Approval

* Abbott Laboratories' (NYSE: ABT) Navitor transcatheter aortic valve implantation (TAVI) system has received a CE mark, making it available in Europe to those with severe aortic stenosis and a high or extreme risk of complications from surgery.

* TAVR systems offer a less risky, minimally invasive alternative to open-heart surgery to treat aortic stenosis, where the aortic valve narrows and restricts blood flow out of the left ventricle to the aorta, weakening the heart muscle.

* The Navitor valve is implanted using Abbott's FlexNav device, which received its CE mark last year. The catheter is designed to improve the flexibility and stability of other TAVR delivery devices and can be used in patients with aorta diameters as small as 5 millimeters.

* In the U.S., the Navitor system and FlexNav delivery device are only available for investigative use.

* Price Action: ABT shares closed 1.33% lower at $116.74 on Monday.