9月17日，在2021年度美國(guó)銀行全球醫(yī)療大會(huì)上，美敦力執(zhí)行副總裁Rob ten Hoedt 表示，美敦力軟組織機(jī)器人輔助手術(shù)系統(tǒng) Hugo RAS 已于今年3月份向歐盟提交認(rèn)證申請(qǐng)，認(rèn)證過(guò)程大約需要六到九個(gè)月，這意味著Hugo RAS將于近日獲得CE認(rèn)證。

雖還未獲得CE認(rèn)證，但目前已有很多客戶簽約Hugo RAS系統(tǒng)。Rob ten Hoedt 透露美敦力已經(jīng)開始建立一個(gè)強(qiáng)大的銷售、培訓(xùn)和教育團(tuán)隊(duì)及應(yīng)用或服務(wù)團(tuán)隊(duì)，以滿足市場(chǎng)對(duì)美敦力Hugo RAS的期望。

Hugo RAS系統(tǒng)目前只申請(qǐng)了泌尿科和婦科兩個(gè)手術(shù)領(lǐng)域，Rob ten Hoedt預(yù)計(jì)手術(shù)量約占市場(chǎng)的54%，接下來(lái)將在腹部和結(jié)直腸等領(lǐng)域提出認(rèn)證申請(qǐng)。

Rob ten Hoedt表示，從成本的角度來(lái)看，末端執(zhí)行器的成本與用于手術(shù)的成本大致相同。美敦力有一個(gè)龐大的服務(wù)組織，可以為那些在資本方面有問(wèn)題的醫(yī)院提出創(chuàng)造性的融資解決方案。運(yùn)營(yíng)挑戰(zhàn)，這完成了美敦力的總體主張。

美敦力的高層正在將手術(shù)機(jī)器人結(jié)合戰(zhàn)略客戶管理和美敦力提供的服務(wù)以及外科產(chǎn)品，這種新的營(yíng)銷組合給其在市場(chǎng)上帶來(lái)巨大的優(yōu)勢(shì)來(lái)對(duì)抗現(xiàn)有的競(jìng)爭(zhēng)對(duì)手，期望將機(jī)器人輔助手術(shù)的滲透率從目前的 2% -3% 提高到更高的水平。

Hugo RAS系統(tǒng)為更多人、更多地方提供了機(jī)器人輔助手術(shù)的可能性。

官方介紹

創(chuàng)造更多可能性的機(jī)器人設(shè)計(jì)

Hugo RAS 系統(tǒng)正在改變執(zhí)行機(jī)器人輔助手術(shù)的意義。其模塊化、便攜的設(shè)計(jì)結(jié)合強(qiáng)大的分析功能，讓手術(shù)團(tuán)隊(duì)掌控一切，幫助醫(yī)院突破經(jīng)濟(jì)壁壘。模塊化設(shè)計(jì)可以將機(jī)器人從一個(gè)手術(shù)室轉(zhuǎn)移到另一個(gè)手術(shù)室，而不必將一個(gè)手術(shù)室專門用于機(jī)器人手術(shù)。

保留您信任的手術(shù)工具

Hugo RAS 系統(tǒng)能夠滿足每位患者的需求。因?yàn)樗脑O(shè)計(jì)與時(shí)下在腹腔鏡和開放手術(shù)中使用的許多相同技術(shù)兼容。

獲得強(qiáng)大的手術(shù)洞察力

Touch Surgery Enterprise 是基于云的手術(shù)視頻解決方案，旨在讓使用者安全地訪問(wèn)、分析和共享手術(shù)視頻。AI 驅(qū)動(dòng)的 DS1 計(jì)算機(jī)可以直接從手術(shù)室記錄、匿名化和上傳手術(shù)視頻。

摘抄英文原文如下（會(huì)議對(duì)話）

Bob Hopkins

Okay, okay. Yes, that’s helpful. Okay. So now, maybe to move on to more Medtronic specific data points and questions. And one that I like to start with that I'm sure you've gotten a lot of questions on over the course of this week is, I just wanted to kind of get your updated view on a lots of Medtronic’s soft tissue robotic program and Hugo. Maybe the first question from me is just to kind of reconfirm timelines if you're able to do that. I mean I think earlier this year, Medtronic said they'd be filing sort of by the end of March and then maybe six months later or so, nine months later there could be an approval. Anything changed with your estimates as to when the system could be approved in Europe?

Rob ten Hoedt

No, there's nothing changed, Bob. So we're sitting at the [tip of our] chair waiting for the phone call that the product will be approved. So we're in shooting range and it should happen in the next coming time. So in the meanwhile, we started to build a strong sales team, training and education team, app or service team, so that we can service the market to what it's expecting from a company like Medtronic for a product like this. And it's been fantastic to see how European market has reacted to that. We're seeing a very, very interesting levels of demand. We've been very targeted in the way that we wanted to place our first units.

So we already signed up a number of accounts prior to actually having the CE mark. So these people just take a bet on us, because they want to have the system in their in their clinics. It's a mix of people who are used to using intuitives that doesn't see and have already one or two devices and as a third or a fourth one, that’s been the Medtronic one, it's also the noble accounts but very important key opinion leaders. So our first wave of customers that we will be able to announce is when the time is there is a group of very renowned users of robotic systems and key opinion leaders in the region. So the launch is going very, very well and now waiting for the approval to come along.

Bob Hopkins

And then what -- is there a common theme among the various accounts you’re talking to that's driving the level of interest that you're describing here?

Rob ten Hoedt

Yes, there are a few common themes there, Bob. First of all, I don't think we are launching a robot as a color manipulator. We are basically launching the future of surgery. And what we're hearing, if you go down to the device itself, we are hearing very positive comments about our modular design. A modular design allows us to move a robot from one OR to another OR, you don't have to dedicate an OR to robotic surgery with all the difficulties that come with that with hourly planning. Sowhat we then do you say, it's going to probably take the whole day and that means that you only do one procedure per robot. We think that we can change that with the design and the modular approach. That's one.

The second part of the modular approach that we're hearing back is that the nurses who are still standing next to the patient are feeling a lot of freedom to maneuver and work, which is a big advantage for the operating nurse. The doctors, they are sitting behind the flat screen with a 3D view, they don't have to sit with their head in these binoculars. And so they're really part of the operating room, the team work that is required is continuing to be there and that's a big advantage people see. Because everybody can watch over the shoulder of the physician that the physician is not alone and so support can be given either training or training other people.

The other part is around the end effector. The fact that people can use the same end effector that they are using in their minimally invasive work and in their open surgery work for Medtronic is a huge advantage. A, from a cost perspective, because obviously the cost of the end effector is more or less the same as what they're using for their surgeries today, but also the fact that they can use the best staplers, the LigaSure, all these products that they are so used to in entrusting and using. If you stop that then with the fact that we have such a large footprint and we have a big service organization, and we can come up with creative financing solutions for those hospitals who have problem on the capital side of the equation or for hospitals who have operational challenges, that completes the overarching proposition that we have.

Let me finish with adding the Digital Surgery solution on that, because that is the first glimpse of how surgery in the future will look. And so Digital Surgery allows them to take every single step along the way. AI tools will help them to get learnings back on which steps could be done differently to get a better outcome. And that starts the whole flywheel of improvements in surgical treatments and becoming more standardized and protocolized in the way you do procedure. So that's in a nutshell the story of our robots and I think it's going to be an incrementally important product for Medtronic but most importantly, for the hospital with the patients.

Bob Hopkins

Thank you for that. I kind of noticed in those four categories that you rattled off, cost was tangentially a part of the end effector conversation, but it certainly wasn't one of the things you lead with. And so I'm just curious where does cost fit in overall in terms of the relative cost of the capital and the relative cost of the instrumentation versus da Vinci? Where does that factor into into this equation?

Rob ten Hoedt

So the capital, at least what we're seeing is that the capital cost is not the big problem. What is a problem is the fact that the da Vinci end effectors are much more expensive than the normal tools that they use in minimally invasive or open surgery, and that puts a bit of a blanket over the usage of da Vinci, because the operational costs are so high. So that issue we can take away with our approach, which I think is important that a robotic surgery is being chosen for the benefit of the patients, and it shouldn't be hindered by an unnecessary cost increase.

No worries. We'll know soon enough hopefully. And then when the approval comes, what is the strategy from a rollout perspective? Will it be limited in terms of geographies or indications, or will it be across Europe, how should we think about that?

Rob ten Hoedt

Yes. It's going to be across Western Europe, to begin with. And we want to have it nicely, evenly spread over the different countries in Europe. But it will be Western Europe focus. Also because demand is high and we want to be able to build enough robots so we can satisfy that demand. And our targeted audience is obviously opinion leaders and very large medical systems.

Bob Hopkins

And then before I talk about indication, one thing that I think is potentially interesting here is that in your broader general surgery business, obviously, you have some very good competitors with J&J and a number of other smaller companies. But you're going to be the only, really the -- only the second major company to launch a soft tissue robotic company in terms of a large company with a broad offering. And this is a little bit of a softball question. But I'm really curious to hear your view on whether or not you feel like having -- only second large company and the first broad based company to offer a robotic solution like this. How much that puts you in an advantageous position in terms of selling all of your traditional general surgery technologies, relative to the competitors that don't have an offering like this?

Rob ten Hoedt

Yes. I think you're hitting on a very important point where if you look at the operating model change that we made at Medtronic with the 20 OUs and the geographies who are taking responsibility for the strategic accounts and the large hospital systems where Medtronic all comes together. And obviously, the SI sales organization, our surgical sale organization in collaboration with our strategic account organization and the robotics team, are working all hand in hand to make sure that one opens the door for the other to come in and allow a large contract to be signed. So it is not just about selling a robot, it is about partnering with large hospital systems on the future of surgery. And the robots in combination with strategic account management and the services we provide and our SI footprints, surgical products footprint, that combination should give us, has to give us, a unique position against the existing competitor of robots but it should also allow us to make some significant inroads into this market and start growing the number of surgical -- robotic surgical procedures from what it is today, what is it, 2% to 3%, to much larger numbers.

Bob Hopkins

Could you -- said more specifically, do you think that this makes you more optimistic about the growth potential for just your core stapling energy and general surgery business, because of perhaps the pull through benefits from broader contracting? And how real opportunity is that? I know it's like easy to talk about it and verbalize it but just curious how real an opportunity you think that is?

Rob ten Hoedt

Well, we demonstrated, Bob, with our service offerings, through our integrated health solutions that we have the capability and the competency at Medtronic to create pull through where all of our OUs can benefit from -- through these large partnership agreements that we do with hospital systems. And the robot is actually putting that on steroids, because the robot is a product that is very wanted, there is huge demand. And I strongly believe that we should be able to tie this into overarching contracts where the different operating units and specifically the surgical one can benefit from.

Bob Hopkins

Okay, that's helpful. And just remind us in terms of indications, how broad an offering you'll have initially in terms of different [Multiple Speakers] on the robot?

Rob ten Hoedt

Right. The initial approval will be for urology and gynecology, which is roughly about 54% of the market. So we will be playing in a significant portion of the market and the rest of the approvals will follow after that, which is the abdominal and colorectal et cetera. But the initial will be urology and gynecology.

Bob Hopkins

And is that process of additional approvals, does that take a long time? Is that something that can happen at a fairly rapid pace? How do we think about that?

Rob ten Hoedt

Yes. We're going to have to do that in probably case-by-case and we have to have enough data to be able to submit. And then the moment we can submit, we're going to have to wait the normal time, which is that six to nine months before we get the approval. So that's a little bit the sequence of activity.

Bob Hopkins

Okay, great. So just one other topic I wanted to hit on before we close here is we're coming near the end of the period. I did want to get your opinion on the outlook for Renal Denervation and hypertension in Europe. Because you have a unique perspective in that, there's a little bit of product that's been sold because of approvals in Europe. I know there's not reimbursement, so it's quite small. But as someone that's got a little bit of a sense for the market, at least. If we take the leap and make the assumption, my assumption that the data will be positive. How do you put the opportunity for Medtronic for Renal Denervation and hypertension in perspective, assuming good data? If all the things you're looking at, if there's good data, where would you kind of place this in terms of enthusiasm and excitement?

Rob ten Hoedt

Yes. Well, it's a great question, Bob. And you're so knowledgeable about what's going on in the market. So I need to be careful, I give you some new information. But here's the Renal Denervation journey. We have launched Renal Denervation, whatever, six, seven years ago. And physicians in Europe, although, it wasn't broadly used but it was used in quite a number of centers, the doctors were really happy with the results. And so when we did our trial in the US where we missed our endpoint, European physicians actually couldn't really reconcile what happened in that study versus their own experience. But the reality was the reality and reimbursement wasbeing pulled one by one out of the market, because of those data and basically the business dried up. There's a few centers that have continued to do it with local budgets, but that's about it.

So the moment we're going to see positive results coming out of the trials, immediately the physicians in Europe who have experience with Renal Denervation will say, you see, that's what we saw all along. So normally, what then happens is that, together with the company, we built a file, they help us to bring the files to the payers and we will start to argue country by country and sometimes region by region for reimbursement. And if you ask me what will happen is that that will exactly happen. So if we get the positive data, the reaction of physician in Europe is going to be, you see, we said that all along and together we're going to try and file as quick as possible to see if we can get some level of reimbursement up and running. And we're going to try and do a number of submissions to the European Society of Cardiology so that they can revisit the guidelines, which today, the guidelines say, it should only be used under a clinical protocol of some sort. And obviously, we need to get a little bit more freedom on those guidelines also. So that's how I look at the European reaction.

Bob Hopkins

Okay, that’s helpful. Thank you. So I look forward to seeing that data, engaging in the reaction, hopefully, a little bit later on this year. So we're almost out of time here. But just in closing, were there any last kind of key messages that you want to leave investors with in terms of the outlook for your business in your geographies before we close, just curious kind of one or two maybe take homes, and then we'll move on.

Rob ten Hoedt

Yes. Well, thanks for that opportunity. And this sounds like a marketing sales story, but I'm not the kind of a person that. But I tell you, I'm 30 years with the company and I have never ever seen the company having such a rich product pipeline of such relevant products ever, basically ever. And that we need to execute upon all these things. But if we do that well, this company has an incredible opportunity to return to 5% plus and start to giving a real number to the plus, because there is opportunity for us to grow this company really nicely. If you take Hugo, if you take Argon, if you take our rebound in diabetes that we will get through in the United States and we see the first steps in Europe with the 780G, with the new [sensor] and the way we're growing that business again, Transcatheter Valve, the Mitral Valve that come after that, there's so many places and basically, in every business unit, we see incredible opportunity, so -- for growth and market share gains.

So I'm really optimistic for the future. And our emerging market strategy, we started with that seven years ago. We didn't want to see our emerging markets anymore, it's just cherry on the cake but as a real driver. And today, we have 16%, 17% of the company's revenue coming out of emerging markets and those markets all have an ability to grow between 10% and 20%, that's another huge growth factor that we have as a company. So yes, it sounds a bit cheesy and marketing but I can't make it anywhere different, this is what it is.