Medtronic’s Stacey Pugh discusses the Company’s new Riptide Aspiration System, new products in development, and growth strategies for the neurovascular business in a podcast interview with SmartTRAK at the International Stroke Conference (ISC) 2018 held Jan. 24-26, 2018 in Los Angeles, CA.
Anne Staylor here with BioMedGPS. We're at the International Stroke Conference in Los Angeles, and today I'm talking with Stacey Pugh of Medtronic Neurovascular. Hi Stacey, thanks for joining me.
Stacey Pugh: Happy to be here.
Well, first of all I'd like to say congratulations on your recent FDA approval for the Riptide Aspiration System.
SP: Thank you.
Walking in the exhibit hall, I could tell right away that this was the buzz of the meeting. I talked to other manufacturers here and many were actually surprised, you caught them off guard, to see Medtronic get that approval. Some thought your regulatory strategy was brilliant.
SP: Well thank you.
Why don't we start by having you discuss a little bit a bout Riptide, how you brought it to market and what differentiates it from other current and emerging aspiration systems for stroke?
SP: Well I will tell you from the standard, to get a 510(K) approval with a predicate by definition, the system is substantially equivalent to the existing aspiration systems that are on the market today. This is an area of stroke that we didn't play in before.
We've seen emerging trends where this gets used adjunctively with our Solitaire technology and where physicians sometimes use it alone as an approach where they use stent as a secondary. Our general philosophy on stroke is we're going to be a full player in the portfolio, not only in product portfolio but in stroke solutions as well.
This was a missing element in our portfolio. I think what you're hearing people talk about, whether it's through their first hand experience or through hypothetical experience, there was a lot of question about whether or not achieving a 510(K) in that area without a clinical trial was actually going to be possible.
I think when people say they were surprised, that's what they're speaking to, as to the fact that we were able to bring this approval forth without the conduct of a clinical study. Having said that, there's a substantial amount of testing, both animal and bench and otherwise that really demonstrates what we would call equivalence of the system.
This is the initial step of what you will see from Medtronic this year as a number of launches. We will have additional aspiration-focused catheters coming mid-year that are tied to this system. We have to Arc catheter, that was designed to be used for delivery of Solitaire in adjunctive aspiration that now has an aspiration indication. Further technology and launch will come. This is just the beginning of our entrée into that space.
Can you talk a little bit about the device itself? What's going to differentiate that in the market, do you think? ...
SP: I'm going to tell you. Do I think the pump itself, the pump technology is highly differentiated? I don't. I'm going to be honest. I think we have a system that is a very reliable system that meets all the requirements to be able to deliver aspiration therapy. Do I think the system itself is highly differentiated from the existing? I don't think it is.
I think what we bring to this, the differentiation for us is the fact that this system, and our full portfolio, has been designed such that all of these products are appropriate for utilization together and that will be important as we bring additional technologies forward. I think it's important to acknowledge that it is part of a system approval, and that there was a predicate for this.
Do I think anybody's going to be bringing highly differentiated pump technology? I don't, and I don't think the physicians believe that that is what is going to drive efficacy for the therapy. I think what we bring to this, the differentiation for us is the fact that this system, and our full portfolio has been designed such that all of these products are appropriate for utilization together and that will be important as we bring additional technologies forward.
I don't think anybody thought to bring the whole system. I mean everybody's been so focused on creating a catheter...
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