Competitor FDA approval, page-10

Yes, the Navitor is another device with 3 leaflets sewn together.

I can't find much info on the performance of the device other than the minimal data on Abbot's website. They tout a mean gradient of 7.4 mmHG as determined by echocardiograph 30 days post-implantation, compared to 6.4 for the Evolut and 10.6 for the Sapien. So it's not an improvement over the Evolut. They also claim an EOA (I'm assuming for a 23 mm valve) of 2 cm squared compared to 2 for the Evolut and 1.5 for the Sapien. These results are referenced as being available in the Navitor's instructions for use, but I can't find that anywhere on the Abbott or FDA site. The IFU for the prior generation Portico device is the only one available.

The problem I have with all of these comparisons is that it's tough to sift through all the data and claims and come to definitive comparisons objectively. There are different trials and bench tests and the 6 min walk test is stratified by the subjective speed of walking at baseline....it's really confusing. I feel for doctors trying to discriminate between the different TAVR devices.

One thing from Abbott's pivotal trial that may bode well for us is the fact that they only needed to enroll 333 patients. If our trial could be that small it would be great but the Navitor is an improvement of an existing device, not a novel one, so we could still need more patients. Following patients for a year does appear to be the standard for pivotal trials.