Da Vinci FC (Flexible Catheter) is coming
Recently the first visuals of the new da Vinci flexible catheter (FC) system were revealed. The system assists CT-guided lung surgery, primarily with tissue biopsy. It is being developed parallel to the Sp. Last year, Intuitive created a $100m joint venture with the Chinese Fosun Pharma to bring these systems to the market. Some comments on the potential of the FC system from CEO Gary Guthart:
"With FC, we can bring in our concept and our technology with a couple of things. One is we have novel sensing technologies that allow us to sense all the way along the catheter length with a high degree of certainty. That helps us in terms of understanding and navigating tortuous pathways. That's one.
The second thing is the use of robotic assistance gives you stability and navigation capabilities that are very hard to do manually, and so those are technical benefits. What could they result in, in terms of clinical benefits?
The hope there is that you can get to more distal locations that are otherwise hard to get to in tortuous pathways and that are more accurate in terms of tissue sampling because you have high degree of stability and better imaging and targeting now.
Those claims have to be backed up, and so that's the hypothesis. And that's the set of trials and data and analysis that we’re going after. And I think people are excited about flexible technologies in general by some of the technologies that our competitors and other med companies have put out there.
I think the excitement is there. And the question is, can you go a little further and get a little more predictability. And we think we have technologies and capabilities that can do that.
We think it will have a global appeal with FC, but I think you're right that United States and China and then Europe will be interesting. In terms of timing, a lot of it will be predicated on regulatory pathways and what kind of data requirements there are.
We think there are real opportunities in China. We're going to make sure that we do that right with our joint venture partner. We likewise, think there is in the US and not ready yet to call when the launch dates are for both sets, because of negotiations with clinical trial results.
Europe likewise, I think there's a little bit of uncertainty right now as to what kind of submission package will be required and that's one of the things we're in the midst of working out both internally and we have conversations with regulatory authorities over time.
We will do a controlled launch when we're ready. So we've told you don't model any revenue into ‘18. We have not yet published and are not ready to publish when the final launch will be. We'll let you know as we get closer to some of the certainty on regulatory timelines.
The results of the Australian clinical trails were very positive for us. We were really happy with what we saw. I think the scientific principal investigators need the chance to write their manuscripts and analyze the data and present it in a way that makes sense to them. So we will wait for that, and as we get clarity there, we're sure to share it with you."
Source: Intuitive, Seeking Alpha