FirstLook

研报英文原文证据摘录

FirstLook

EW (& MDT, ABT) – TAVR NCD Proposal positive & meets all key criteria investors were looking for

The updated TAVR NCD proposal is a significant win for EW, aligning with key investor expectations. This newly released

proposal from CMS expands coverage, focusing on both asymptomatic and symptomatic patients, which bolsters EW's outlook

considerably.

Key Updates: The removal of coverage with evidence development (CED) for symptomatic AS patients empowers TAVR's

current evidence, affirming its necessity. The introduction of an asymptomatic coverage pathway through a CMS-approved CED

study marks a notable advancement for patient access to care.

Operator Structure: The new allowance for a single qualified operator to perform TAVR simplifies procedures significantly,

streamlining scheduling and potentially reducing operational costs for hospitals.

TAVR Volume Requirements: By lowering annual TAVR volume requirements from 50 to 15 procedures, this shift opens the

door for new centers and aligns more closely with market dynamics, enhancing overall access to care.

Additional Key takes:

• Asymptomatic Coverage Implications: While the inclusion of asymptomatic patients is promising, clarity on the

'active, contemporaneous comparator' is needed to fully understand operational impacts.

• Reduction of Regulatory Burden: Lessening CED requirements for symptomatic patients alleviates regulatory

pressures for EW and peers, potentially increasing procedural volume.

The overall market sentiment suggests that EW shares are expected to rise low single digits to mid single digits today, reflecting

the optimistic environment fostered by these developments.

Healthcare Technology & Distribution Elizabeth Anderson (212-446-5632)

Health Care elizabeth.anderson@evercoreisi.com