Specialist
Cardiologist at Heart House NJ
Agenda
- Customer assessment of Edwards Lifesciences' (NYSE: EW) vs Medtronic's (NYSE: MDT) vs Boston Scientific's (NYSE: BSX) TAVR (transcatheter aortic valve replacement) offerings vs surgical valve by patient risk and age
- patient risk and age 2. Clinical advantages of Abbott's (NYSE: ABT) Portico minimally invasive FlexNav delivery system and potential pricing’s impact on uptake
- Abbott's recent European launch of its newer-generation Navitor TAVR implant and FDA approval outlook
- Pacemaker rate concerns around the Navitor
Questions
1.
Could you outline the patient population for TAVR [transcatheter aortic valve replacement], including how we should segment it and what the standard of care is?
2.
What’s the treatment paradigm for TAVR? At what stage is it or open surgery considered as options and in what line of therapy?
3.
What percentage of patients typically get TAVR vs surgical valve?
4.
You said TAVR was historically only approved in the higher-risk patient category, but there’s now been the expansion for intermediate and lower-risk patients. How has this encouraged uptake and how does the broader set of indications encourage adoption among physicians?
5.
Could you elaborate on the surgical valves’ benefits over TAVR?
6.
You use Edwards’ Sapien 3 and Medtronic’s Evolut TAVR offerings. How does your usage of each differ and how regularly do you use the two offerings?
7.
You said your usage splits 70/30 Edwards to Medtronic. How might this split trend longer term? Do you think it will be fairly stable?
8.
The FDA recently approved Abbott’s Portico with its FlexNav TAVR system. What are your thoughts on this device and how disruptive might it be to your usage?
9.
You mentioned the Portico will only serve around 5-10% of your patient population. How might your usage split trend across Edwards, Medtronic and Abbott? Where could Abbott take share from Edwards or Medtronic with the patients you treat?
10.
You mentioned Boston Scientific, which had Lotus and eventually had to pull that option. Could the company’s arguable failure make people slightly more sceptical for Abbott’s launch, considering it’s a new option on the market when there’s already the tried-and-tested Edwards and Medtronic options you’re used to using?
11.
You mentioned pricing as perhaps a sticking point around the TAVR offerings’ uptake vs surgical valves. If Abbott came in with a lower price than Edwards or Medtronic, could that lead to a bigger shift in uptake despite the smaller indication?
12.
You mentioned pacemaker implantation, which was required for 15% of Abbott’s study participants. There was even higher pacemaker levels in Medtronic’s clinical trials and then that’s lowered significantly. How much of a drawback is the 15% figure in the studies for Abbott’s devices compared to Edwards and Medtronic’s? How might the pacemaker level decrease over usage?
13.
It seems we don’t necessarily have much long-term data for TAVRs, so there are some unknowns. What are the potential long-term risks associated with TAVR data? What should we be mindful of and how much of a concern are these to you?
14.
How often do removal procedures happen?
15.
Some medical literature suggests the lifespan of the tissue valves used in surgical aortic valve replacement is typically about 10-20 years. TAVR valves are made of the same biological tissue. Could we expect their longevity to be similar? What’s your outlook?
16.
We recently had three Medtronic events and five-year data from the company’s SURTAVI trial with intermediate surgical risk for treatment and that was mostly with its CoreValve device. The rate of all-cause modality or disabling strokes in the TAVR group was 31.3% compared to the surgery cohort’s 30.8%. How should we interpret this data? How positive is it for potentially encouraging TAVR uptake among physicians?
17.
The trial data between the surgical and TAVR cohorts doesn’t differ that much. This is an older trial, as you mentioned, so as more of the five-year data comes out and the cohort results are quite similar, could this encourage higher TAVR uptake?
18.
There’s also the Navitor, a new iteration of the Portico, which boasts a new sealing cuff meant to reduce PVL [paravalvular prosthetic leak]. How much of an issue has PVL been in the Sapien 3 and Evolut and how Private and confidential 12 much of a concern is it to you as a physician? How promising does the Navitor seem around helping reduce PVL with the new sealing cuff?
19.
Edwards recently reported economic implications of choosing TAVR vs surgery in particularly low-risk patients. TAVR devices are far more expensive than surgical, as you highlighted. How does the pricing compare between TAVR and surgical, breaking down the cost? How important is pricing in decision-making?
20.
In its recently reported economic implications, Edwards also highlighted over two years of TAVR follow-up costs was around USD 2,000. Does that sound accurate to you? What might be involved in these follow-up costs compared to open surgery?
21.
The cost of TAVR procedures could decline as increased competition enters the market. How would a price decline impact your adoption of TAVR vs surgical valves? What could a split be if the price were to decrease?
22.
You said Medtronic have been quite aggressive with cost-saving initiatives and Edwards has perhaps not been as aggressive, and that seems to be the number one valve among physicians. Might there be more of a cost-savings initiative from Medtronic and Abbott in the short term as they try to compete for the number two spot? Will Edwards remain fairly stagnant, at least in the short-to-medium term?
23.
Bicuspid patients are a key patient population not currently included with TAVR. They’ve been excluded from landmark TAVR trials historically, but observational studies suggest bicuspid patients could share the same early benefits as other TAVR recipients. What are your thoughts on this? What would you need from a trial here?
24.
How much of a need is there for TAVR approval within the bicuspid population? Could there be significant demand for it if there are good trial outcomes?
25.
What do we need from future innovations within the TAVR market? What would you like the next development to be?
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