Ottava: Clinical data tear down
- Steve Bell
- 6 days ago
- 18 min read
Firstly, before I get into the details of what I think this data shows. I would like to congratulate the team at Johnson & Johnson for getting this far. The “Ottava” project has been plagued by set backs, delays and issues. Most of that has, from my point of view, been self inflicted via internal politics, bad “bake off” decisions, and a host of well publicised issues.
But despite all of that - the current team have been able to ride the storm - pick up the best of the Verb system (the bedside design) and the best of the iPlatform from Auris (The console) and mix them together to give us the long awaited OTTAVA
A little history on the Ottava system from my viewpoint
It’s hard to piece everything together but from patents, images leaked to twitter, different congress presentations, images from the website, the product reveal renderings, legal court documents and “noise” - I have assembled in my head these things that point to this.
Let me talk about the failed things first: It’s only what I think.
The iPlatform was trying to use a unique way of controlling instruments by taking an end terminal joint of the arm that was much like a Monarch Arm (Kinova I think) that allowed the instruments to pass through the centre of a doughnut like interface. That doughnut became the seal and top of a metal Trocar. The instruments would pass through and that could be a rigid instrument or a flexible scope. Lots of diagrams on this.
The advantage of this would be that the arms would hardly move at all - almost zero clash. And it would be that doughnut moving around that would give direction to the instrument. Then the “wheels” inside the doughnut would move the instrument in and out avoiding the need for a Z rail.
Ingenious thinking. BUT…
Getting all those big doughnuts in the same space to have ports close together is an issue. The angles they would need to tilt at to get full abdominal coverage would be wild and maybe dig into the patient. And the complexity of controlling cable driven instruments through a doughnut interface would mean at least 6 interfaces and some kind of weird winding mechanism that would try to keep constant cable tension in instruments. That would have made instruments impossibly complex and expensive. Great R&D - impossible commercial product.
Verb - which I think has become the Ottava bed - instead chose to have arms from the bed - and Z-rails on the end so you could have very da Vinci like instruments - but possibly shorter - more compact and with less Z rail travel (if the mechanics in my head work.) Much closer to da Vinci terminal parts of the arms. Simpler, “normal” wristed instruments - but maybe a little more risk of arm clash as Z rails move about in 3D space above the bed more than an iPlatform mechanism would have.
Verb though had one of the wackiest “cockpits” I’d seen (at the time) with untethered “balls” as controllers - screen and periscopes capability - a pretty wild departure (back then) from what most surgeons were used to with an Xi.
Interestingly if you took Surgurii and SSi cockpits and gave them a love child (with a little dabble by Kangduo) - you end up with more or less the Verb cockpit. So my bet it wasn’t as dumb as people who’d tried it said. (Don’t rely on Xi users for feedback 10 years ago is the moral of that delay.)
But the iPlatform had a standard da Vinci like cockpit / console which was reportedly quite nice. And I think what I saw Monica Hagen on at one of the meetings - is the later form of the iPlatform console - which is of course now the OTTAVA console.
At some point the teams worked out that the bedside of Verb was right - and the console of iPlatform was right - and they went on a mating mission. So maybe - the bakeoff didn’t do what it was planned to do - but did knock some logical sense into the teams?
Whatever - we do now have the Ottava (a bit late) but in my opinion probably a more realistic and sensible combination of components. I think this is a “commercial product” not an R&D dream.
BUT - the one thing about iPlatform design - it feels to me it is way further away from the IP badlands of Intuitive. Where as the current paradigm of “similar console concept” and - Z-rails and familiar instruments and drive interfaces - gets closer and closer to a da Vinci architecture. It is maybe not by chance that iPlatform was so far away as it had the legendary Dr Fred Moll behind it - who knew a thing or two about robots and patent landscape.
If you’d have put the the Verb console and the iPlatform bed side together - I think the beast that would be Ottava would be so different to a da Vinci it would be miles away from any IP and with much better FTO, and would be having its own solid IP moat. But this is just the opinion of a lay person that is trying to put fragments of info together.
Anyhow - enough of what I think went on - let’s get back to reality and ther .current press release.
Roll forwards - the current clinical data release and press statement on OTTAVA
So as a refresher - the IDE for this trial was late 2024 - cases enrolled 2025 - and the enrolment finished 2025. A new IDE has now been submitted for expanded indications in Hernia BTW.
The first trial was named the FORTE trial - it was led by Dr Erik Wilson (M.D., Chief of Minimally Invasive and Elective General Surgery, UTHealth Houston, Director of Bariatric Surgery, Memorial Hermann-Texas Medical Center). Now just right there - that is a smart move. Erik is a great surgeon and has been on nearly every system - and every prototype. He’s not a regular jobbing surgeon that does robotics - he’s also a technologist that understands deeply how robotic systems work - pros / cons and how to ensure they can complete cases. I’ve been in a ton of labs with Erik and this was a smart choice by the OTTAVA team.
So let me pull out a few bits from the JNJ release that I think are worth dissecting.
“OTTAVATM - Robotic Surgical System” is the formal name they give it here. Not RAS - Robotic Assisted Surgery. Interesting as the Ottava description is more aligned with Intuitive and how it describes da Vinci. I find that a very interesting - small - but telling slight in the name.
The trial is described as “a prospective, multicenter clinical study evaluating the safety and performance of the system in Roux-en-Y gastric bypass procedures. “
So importantly - multicentre (we will come back to this) and it looks at both safety (of course) and performance - which we will come back to.
For those that don’t know Roux-en-Y is a method of bypassing the stomach. Here’s a simple description but go Google it:
“A Roux-en-Y gastric bypass is a type of weight-loss surgery that reduces the size of the stomach and changes how the small intestine handles food.
The procedure involves two main steps:
Creating a Small Pouch: The surgeon separates the top portion of the stomach from the rest, sealing it to create a small pouch about the size of an egg. This drastically limits how much food can be eaten at one time.
Bypassing the Small Intestine: The surgeon cuts the small intestine, connects the lower part directly to the new small stomach pouch, and then reattaches the upper part further down.
As a result, swallowed food goes straight into the new small pouch and then directly into the lower small intestine, bypassing most of the stomach and the first section of the small intestine. This results in both eating less food and absorbing fewer calories.”
Now this is important as it is not a simple procedure like a fundoplication - it requires complex multi quadrant dissection, vessel management, stapling (often) or hand sewn anastomosis (sewing back together) or oversewing.
I cannot read any more into this than the data says - but often this would require a vessel sealer - and a stapler. The big question is - for this trial did they use a robotic or manual vessel sealer? And did they use a stapler? And if so was it a hand held Ethicon 4000, or was it a robotic Ottava 4000? (I'm naming it the OTTAVA 4000 but that's my made up name.)
(Come on team release some details.)
Why commercially this is important to me. Coming out without a vessel sealer in 2026 / 2027 is unforgivable. So I would imagine that they would do everything to get a vessel sealer on it to deal with the Gastric vessels etc. Let’s remember they have two options at JNJ. The Ultrasonic technology - Harmonic. And their Enseal technology (Ligasure like for a bad way to say it.)
I’m going to put a few very very weird facts together here as nothing in life is ever 100% coincidence. Intuitive have released their vessel sealer Extend curved recently - and I’ve seen a lot of push for this. It’s a bipolar - wristed - bladed multi function instrument. In my opinion - Their teams are very good at predicting what’s coming from competition.
Now - nearly everyone out there has a straight (hard to wrist) ultrasonic - that’s the advanced energy they all tout. Not loved by most - bipolar is the weapon of choice for the majority still. Medtronic has a straight Ligasure already on the HUGO RAS. It's getting good feedback.
IF and it’s a big if - JNJ is launching OTTAVA with energy - just by looking at the market - and the DUALTO they plug it into (timing timing timing) - here’s my guess. They have an option for Harmonic on the robot (easy and they did it for Intuitive in the past so not new) - that will be a straight instrument for the Harmonic fans. But I’m going to lay a 70:30 bet they will launch with a wristed Enseal vessel sealer. (Straight away or within 9 months.)
It’s this line that jumped out from the press release: “investigators completed all procedures robotically on OTTAVA™ without conversion to a non-robotic approach.”
Not “conversion to open” not “Conversion to lap” - but conversion to “non-robotic” which could be a naive marketing statement or could be Freudian information. You see to be able to say “Fully robotic” you would not be using a lot of bedside help. And bedside help would often be an assistant using an advanced energy bedside - but that pushed to robotic assisted and hybrid. Would JNJ claim “non-robotic statements” so strongky if a good portion of the case was done manual bedside by the assistant?? I don’t know - but it all starts to point to the fact that they most likely have an energy device - and I bet if they have one - they have both - Harmonic & Enseal wristed.
But that then leads to the reshaping of the stomach and the anastomosis. Most cases in the US today would use a linear cutter stapler - BUT the robot is also a fine suturing machine - and I’m sure they will have tested that - no doubts. So the big 50:50 question is whether they used a hand held stapler (Ethicon 4000) to transect the stomach - and a hand sewn anastomosis? Or is there a 50:50 chance that the system comes with a stapler already on OTTAVA? I mean - they bhave been working on OTTAVA a damned long time.
You see they highlight that “requiring both restrictive and reconstructive steps that typically span multiple abdominal quadrants and leveraging a broad spectrum of surgical tasks” - and why would you choose Roux as a procedure if you were not testing out the ability to staple. This is common today on Intuitive with Sureform staplers.
Caveat: Of course it could still use an Ethicon 4000 hand held - so they use an Ethicon stapler - but honestly it would be very disappointing to have to say “We did robotic Roux-en-Y as is done commonly today - except we used hand held energy devices - and hand held staplers - so they weren’t really robotic cases they were not the standard of care - they were hybrid cases where the robot was used for visualisation - some dissection and some oversewing…”
I mean it could be that way… but seriously? That would be such a fudge.
I think you get away with all these statements IF you at minimum have an energy device. But to be honest why tackle Roux-en-Y if you don’t have a stapler? It makes no sense to me.
"Shut up Steve!" - Well yes to defend your hand held stapling until you can mount it on the system…. But seriously. That would be a very wet squib. I mean - I would love to see a wristed Enseal and a little less excited about a YAW only OTTAVA 4000 - but it would be way more than many companies. Yaw only - boooo - Because all of the robots now with staplers (mainly china) have fully wristed staplers like SUREFORM. The Chinese robotic staplers are wristed not just YAW. Wristed is the benchmark - not just flex.
But if OTTAVA launched with wristed Enseal - and a YAW only OTTAVA 4000 stapler - I’d be still be cheering. But it may disappoint some purists. However - if they used a stapler on Ottava here (big big IF) then it clearly worked - so what do I know - I'm a purist.
The next statement by Hani Abouhalka, Company Group Chair, Surgery “Across open, laparoscopic, and robotic surgery, we remain focused on translating innovation into real-world solutions” - is very telling.
The massive strength that both JNJ and Medtronic have vs Intuitive is portfolio. They will have the power to allow surgeons to have familiar technology they can translate into open - lap - robotic and “in between.”
Do not underestimate the impact of manual lap surgery and robotic arms and towers.
Few important things about towers from robots:
Left field - Stryker and Storz and other imaging companies should be increasingly very very very concerned about market trends. Especially as more of the bigger lap dominant companies bring robots. A) the conversion of lap to robotic but really worry about B)…
B) is the biggie. OTTAVA has 4 arms always there - and one (or all) of those arms will be a very accomplished camera / scope holder. The JNJ scope not the Stryker scope. JNJ has a tower for the robot with imaging - insufflation - energy and Polyphonic. JNJ has open lap and robotic. It is utterly conceivable that OTTAVA is a very handy second assistant in manual lap cases - and the bed architecture here wins. There is no extra cart - or bedside unit - just an arm that pops up from under the bed. One arm for the camera - that plugs into the JNJ tower and scoops up all the data and imaging to Polyphonic. DO NOT UNDERESTIMATE THIS !!!!!
It is much like the playbook being executed by Intuitive with DV5. And the DV5 tower…
The casualty - if you have the JNJ tower in the room - have the OTTAVA camera arm in the bed - then why do I need a Stryker or Storz tower? In fact - I could start to move to solo surgery.
I have said this for 2 years - and am pleased to see Storz make a move on Asensus.
But Stryker - they may be thinking “nah we don’t need a robot.” Watch the 1788 share in the next 3 years closely - I don't want to be the bringer of doom... but. You need tower defence - not robots is all I’m saying.
Now for Intuitive - the ability to deal across open and lap and robotic is maybe less of a threat as more procedures go to robotic. But the “theory” of a single supplier is attractive to some institutions and abhorrent to others. But when you have products across the board (like JNJ) you have the choice to pitch either to the right ears. Those that want a basket of products - less inventory - less reloads on the shelf etc etc - will absolutely buy into this.
Now Intuitive have stepped into the manual lap world with the DV5 tower and the Hologic plug in of their advanced energy system into the DV5 tower. BUT they still miss a hand held Sureform in my book - and I suspect it is sitting in a cupboard - just waiting to see how the market reacts.
AND - I did see some patents for circular staplers in the Intuitive portfolio… so who knows.
This Lap and Open ability is going to start to differentiate the big companies from the smaller companies. It's more moat.
But let me be straight: Fundamentally you can have all the lap product you want - but if your robot is not up to snuff it’s irrelevant. First and foremost robot - then if it’s “good enough” the lap and open becomes a decision helper.
I doubt that out of the gate OTTAVA is a DV5 equivalent. For many reasons and I will do a side by side the minute that OTTAVA is formally revealed and I can see the features. As they may still have secrets under the hood. I hope so as even I want to be shocked surprised and say “Wow!"
Size of OR rooms for Ottava is important
This is a very important piece of information out of the press releases:
“In this study, OTTAVA™ was installed and used successfully across operating rooms (ORs) at all six participating hospitals. OR sizes ranged from approximately 243 to 694 sq. ft. In five of the six sites, procedures were performed in ORs that previously had not been used for robotic surgery, including rooms historically considered challenging for robotic systems due to space constraints.”
Okay so 694 sq.ft - big OR - of course. (64 M2)
But the 243 sq.ft is the interesting one. That is quite small for the USA. (22 M2)
It’s a demonstration - that in the smallest rooms in the USA you can fit a bed - console - tower. And historically these rooms are not chosen for robotics because the boom - bedside unit - adds enough footprint to just make it impractical.
Now be cautious - those super tiny rooms are not always rooms for major surgery. It’s a bit more complex than that in the everyday real world. But it is a good demonstration that it “can fit” and can be used. And that is important.
The statement of “in five of the six sites” ORs that had not been previously used for robotics….etc etc
What I think they're saying. This is a clear statement of intent that they will not be necessarily going head to head everywhere with Intuitive - they can look for places where historically the Xi was considered too big to be used comfortably. (yes ASCs but also smaller OPD ORs, or small ORs in the main block.)
I want to make sure this statement is put into context. It is true that every inch of floor space is vital as you get to smaller rooms. And the base of the Xi or SP is relatively big. It is not just for the time when it is docked at the bedside. It is in the system being away from the bed as the patient is induced - and then the need to manoeuvre a fairly big piece of kit into place. It all just becomes cramped and awkward. It is not impossible but this is about having safe - comfortable working conditions for the circulating staff. Any OR can get an Xi in it - but is that the right thing to do. Is it comfortable to work in there?
By the bed being the robot - there is no extra piece of kit being wheeled around a small space - the bed IS the robot - it IS in place - it does not have EXTRA bases on the floor.
But, remember, it still has the tower and console so more than just the tower of a lap system. So not ZERO footprint. But that lack of boom footprint in some small ORS seems (by this data) to be an enabler for robotics in smaller centres.
So I agree with the premise that OTTAVA could well be used in spaces an Intuitive cannot. But so can a Versius, so can Virtual Incision. For CMR Surgical Versius I’ve seen with my own eyes - in a tiny 160 sq.ft (16M2) private German clinic OR. But that doesn’t automatically mean those size ORs will be used for robotics all the time.
Often those spaces are for smaller lower acuity cases - often non surgical cases. And the size is only ONE REASON robotics has not been done in many small ORs. There are logistics, costs, supportive equipment etc etc. I do not assume from this statement that robotics was not done there JUST because of the size of the robot. I’d need to look case by case. I’d need to ask staff “why?”
To play devil’s advocate, you could actually read this as a very bad statement. “The big important rooms at five of six sites were already occupied by the tried and tested da Vinci systems we use every day... so the only place left was a small backwater OR and luckily with the bed format OTTAVA could squeeze in. We found somewhere it could be used without displacing the da Vinci."
If these institutions had bigger ORs - why not use them?
Sorry I’m being bad to make sure marketing statements are read as marketing statements. It genuinely could be that the sites and JNJ chose those ORs to prove this point. And that even in a hospital full of DVs - if you want more robots, and you only have small ORs, then OTTAVA is a great new option. And you can get even more robotics capacity without costly infrastructure builds. (Don't underestimate the impact of build costs with current robotics in some sites.)
In fact Peter Schulam, M.D., Ph.D., Chief Scientific Officer, MedTech, Johnson & Johnson. - says “we have observed that this system can allow more hospital ORs to accommodate robotics. These results demonstrate that the novel architecture can integrate into existing infrastructure and remove practical barriers to broader adoption.”
Robot console time is a big issue - and scheduling cannot always fix it. Being able to use smaller - oft ignored - ORs for robotics, with no infrastructure. costs, could be a really nice positioning of OTTAVA. I like this. I'd lean into it for sure.
So all of this gives me hope. Why?
Because it is nice to see a company that is not thinking they have to go directly head to head with Intuitive in the same space. They can “nip around the edges” and not require da Vinci’s to be boxed up and moved out. The idea that robotic capacity in certain hospitals can be increased because prior no go OR spaces now open up is nice. Super nice. I think that is a great USP (Unique Selling proposition) and there is market for it. A lot of other stuff has to line up. But why not?
I won’t bore you now - but if you look at just say ASC class C spaces (size, logistics, flow etc) then an OTTAVA has the opportunity to be placed into 500 to 800 of just those ORs.
If you take mid sized hospitals with a spread of OR sizes - there are a few thousand ORs that could benefit from an OTTAVA reduced footprint size. And it would be very wise of them to go there first from a USP point of view. Very few systems could go after that space. I fear HUGO is too big, Xi Clones - big bedside unit etc etc. That doesn’t stop Dexter or Versius - but that is not ramming directly into Intuitive. And in the USA it is that which a company must fear. Does the OTTAVA architecture de-fang Intuitive in those spaces? I think it does based on this data.
The clinical results for OTTAVA that count
“The data show encouraging evidence regarding the safety and performance of the OTTAVA™ Robotic Surgical System in Roux-en-Y gastric bypass procedures,” said Erik Wilson*, M.D., Chief of Minimally Invasive and Elective General Surgery, UTHealth Houston, Director of Bariatric Surgery, Memorial Hermann-Texas Medical Center, and lead investigator for the clinical study.
This data was encouraging enough to form the basis of the FDA de Novo submission of OTTAVA. And Erik is a great surgeon and realist. I trust 100% his take on anything robotic. So based on this - here’s my prediction (as I get asked every day) - not facts - 100% guess…..
OTTAVA will be cleared by FDA for Upper GI by October 30th 2026. Targeting an indication covering multiple procedures in general surgery within the upper abdomen, such as gastric bypass, gastric sleeve, small bowel resection and hiatal hernia repair.
There I said it. This is my best guess based on what I’ve seen, knowing how good JNJ are at regulatory, this data, and the fact they are finally letting someone speak about it.
Expect invite only demos at SRS this year in July, and a very very limited launch starting 2027.
It is going to just take time to get manufacturing up to speed. To get training sorted. To get contracting done.
I have crunched the numbers so you don’t have to. I’ve scoured every job posting - every bit of knowledge (having launched a surgical robot myself.) Understanding the care that must be taken for good systems to launch well into places that will not send them back. The need for having back ups… spares… training systems…. Demo systems.
Supply chain etc etc. Let me put that all together for you…
Long long algorithm I use - but here we go…
Full year 2027 - I predict 10-12 systems installed clinically into sites. First install sites Q1 will maybe get to 100 - 150 cases in a 9 month period. Others will perhaps do 5 - 10 cases per month. Possibly an average of 2.5 installs per quarter.
Don’t take this as the real commercial trajectory - take it as a super cautious first release and learning. It could go faster if they get confidence… but look for manufacturing bottle necks. It always is a major issue.
I predict 1 to 2 software revisions that year to get rid of bugs.
I think the hernia IDE to be completed and submitted as 510K, and then by end 2027 hernia added as a procedure.
Maybe other procedures to start 2027 as an IDE - they need rapid procedure expansion to be commercially viable by 2030.
IF energy devices and staplers don’t get through the first De Novo - possible 510k of those accessories in 2027. But fingers crossed they are available at launch.
Well that’s how I read these press releases when I see them.
Right? Probably not but always happy to share my best guesses, interpretations and thought. Happy to hear your thoughts.
These are just guesses and interporetations by the author for eduaction purposes only
