Edwards Lifesciences: Dr. Fontana meeting highlights: 2Q interventional volume/share trends

Research evidence excerpt

Edwards Lifesciences: Dr. Fontana meeting highlights: 2Q interventional volume/share trends

proval for these patients—which we estimate now

account for >70% of the US TAVR market—not expected until around late 2028.

On the TAVR draft NCD published a couple of weeks ago and now in the public

comment period, Dr. Fontana is cautious around several key proposed changes,

including allowing TAVR to be performed by a single operator versus the current

requirement for both an interventional cardiologist and surgeon in the OR, as well

as relaxing site qualification requirements. He expects HCA to remain conservative

even if the single-operator requirement is finalized. In terms of potential TAVR site

expansion, there are ~1,100 open-heart programs in the US; excluding VA/

government hospitals that are unlikely to adopt TAVR, this implies a maximum of

~175 additional center openings versus ~865 currently. He expects only a fraction

of these potential centers—perhaps ~50–75—to open TAVR programs post-NCD

update, with no meaningful TAVR volume growth accretion, as these new sites

would likely be low-volume programs and would mostly cannibalize volume from

established centers.

On the proposal to expand Medicare coverage for asymptomatic patients, he does

not see finalization as driving a meaningful market acceleration. As noted above,

physicians have already started treating more asymptomatic patients with TAVR

following the EARLY-TAVR readout at TCT 2024 and FDA label expansion in May

2025, ahead of formal coverage. HCA physicians have received no pushback from

CMS in securing reimbursement approval even before the NCD update. While the

policy proposal continues to stipulate that TAVR coverage is limited to on-label