Specialist
Former executive at Edwards Lifesciences Corp
Agenda
- Key trends and developments in the cardiovascular device industry, focusing on Edwards Lifesciences (NYSE: EW), Medtronic (NYSE: MDT) and Abbott Laboratories (NYSE: ABT)
- Clinical procedure complexity in aortic and mitral indications
- Strengths and weaknesses of Medtronic’s CoreValve vs Edwards’ Sapien III
- Edwards’ ability to penetrate TMTT (transcatheter mitral and tricuspid therapies) with newly approved Pascal offering
- 2023 growth outlook and potential strategic M&A
Questions
1.
What are some major trends and developments that you’ve been following in structural heart over the past year or so, particularly around aortic stenosis, mitral regurgitation and heart failure?
2.
Could you outline the clinical procedure to treat degenerative mitral regurgitation to help us better understand the complexity of this operation?
3.
How would you size the TAM opportunity for TMVR [transcatheter mitral valve repair]? Is USD 3bn TAM by 2025 a realistic metric here?
4.
How are players developing more novel devices or assisting clinicians to make the procedures easier for surgeons and to spur adoption? What’s being done on the clinician education front?
5.
Could you clarify what portion of patients might be resistant to blood thinners or anticoagulants?
6.
In the American Society of Thoracic Surgeons database, including 290,000 patients who underwent surgery in 2003-07, 11% had double-valve procedures, replacement or repair, most often aortic and mitral. To what extent has this data shifted over the last 15 years or so? How common is it for a patient to have more than one valve issue today? How are these cases treated?
7.
What’s your anticipated market growth rate for TMTT [transcatheter mitral and tricuspid therapies] over the next 5-7 years as adoption increases and new devices such as the Pascal are fully rolled out in global markets?
8.
The TRISCEND II clinical trials will determine the safety and effectiveness of Edwards Lifesciences’ Evoque valve, a device designed to replace the tricuspid valve with no open-heart surgery. How are you viewing the emerging clinical data for tricuspid replacement, perhaps to give us a better gauge on the commercialisation uptake in TMTT more broadly?
9.
How is Edwards thinking about the Pascal device for tricuspid vs Evoque? Could you compare relative procedural complexity, pricing, target patient and any other benefits and drawbacks of either device?
10.
How promising are some of the clinical data readouts from TCT [Transcatheter Cardiovascular Therapies] 2022 around Abbott Laboratories’ TriClip device for tricuspid regurgitation? What’s your assessment of this offering and its expected path to commercialisation to compete against Pascal and Evoque?
11.
In your previous Forum Interview [see Edwards Lifesciences – TAVR & TMTT Growth Runway & Cardiovascular Device Competitive Positioning – 16 February 2022], you described Edwards as having one of the best roll-outs in TAVR [transcatheter aortic valve replacement]. How do you assess the company’s efforts to get clinicians up to speed on the Pascal, especially considering some of the procedural complexities we discussed?
12.
What are your thoughts on Edwards’ Sapien 3 Ultra with Resilia anti-calcification technology? How does the Resilia innovation help improve patient outcomes? How much of a game-changer might this be for the company?
13.
What’s your updated comparative analysis of the Sapien 3 against Medtronic’s CoreValve? How would you assess clinician attitudes towards Sapien’s more premium pricing position, especially in light of health system profitability pressures? Is it justified, or is CoreValve good enough?
14.
Do you think Abbott’s Portico, or even Boston Scientific’s Acurate Neo2 could make any meaningful traction in TAVR, and at what cost on pricing haircuts?
15.
What are your thoughts on the opportunity in heart failure more broadly? Edwards is currently conducting clinical trials around interatrial shunt treatment. How important is this indication in terms of unlocking the next frontier of revenue growth in cardiovascular and structural heart?
16.
How far away are we potentially from a device such as an interatrial shunt coming to market? What might a realistic regulatory approval or commercialisation timeline look like there?
17.
Are there any up-and-coming names to keep an eye on as potential disruptors in this market for the indications we’ve discussed? Who are you watching and why?
18.
How are you viewing the existing acquisitive appetites among the major cardiovascular behemoths we’ve discussed? What might tuck-in M&A look like to strengthen product portfolios and capitalise on commercial synergies?
19.
How are companies thinking about patient demographic make-ups in regards to launching a successful international commercialisation strategy, especially in more nascent markets such as mitral or tricuspid?
20.
When do you anticipate US health system staffing issues to normalise? What volume compression could we see over the next 6-9 months due to staffing challenges?
21.
Is there anything that we haven’t touched on, or you’d like to reiterate, that might be especially important to highlight when thinking about the structural heart market? For any clients interested, there is also a full thematic Interview on LAAC [left atrial appendage closure] taking place tomorrow [see LAAC Devices – Boston Scientific's Watchman vs Abbott's Amulet – Comparative Analysis & Market Share Shifts – 19 October 2022].
