A view into heart care unlike any other before

With Ultreon, MLD MAX and more, your doctor can get a 3D view of what's happening as AI helps guide the way.

Healthy Heart|Aug. 31, 2021

Here's — M.D., chief medical officer, divisional vice president of global medical affairs for our vascular business who comes by way of Cambridge, Oxford, Duke and Auckland — a man steeped in experience with for the placement of coronary stents in the treatment of obstructions in the arteries feeding the heart.

And here's Nick West — craft beer connoisseur, long-suffering fan of English Premier League club Tottenham Hotspur who also enjoys a hot cup of Joe — a man whose partner says he's got an unhealthy obsession with vinyl records (and, he allows, "She's probably right.") that number in the thousands, though they don't all fit in his prized 1963 .

If this charming, affable polymath ever went to war with himself, it might be waged by these two distinct sides inside his brain: The brilliant, technocrat doc not intimidated by medical equipment that looks like the "cockpit of a jumbo jet: menus everywhere," as he describes it, vs. Analog Man kicking back with a cold one while enjoying the full sonic range of a vinyl record pouring warmly through every crevice of his consciousness.

Thankfully for anyone needing a coronary intervention and doctors everywhere, Nick West gets along swimmingly with Nick West.

Dr. Nick West

With the best and brightest minds at ��«��Ƶ, . It's a tool that "distills down what are the really important things about a coronary intervention and allows someone to do it very easily," West said.

It's the most innovative tech, with all the information your doctor needs, presented in a simplified, easy-to-use software.

And with our new and , it's our latest, best answer to a straight-forward but multifaced question: Could we make OCT work better for patients and accessible to their doctors by making it simpler and easier to use and, therefore, helpful to more people in more places?

The short answer: Yes.

The longer answer — what started it all, how we got here and what's next — takes a bit of explaining.

When Microns Matter Most
The first thing you need to know about OCT imaging is that the original angiograms — two-dimensional X-ray renderings of a three-dimensional situation inside a coronary artery — is something like listening to your favorite music in mono.

You know the tune. But you also know there's so much more you're missing. And for angiograms, it's been pretty much that way since disco.

The next thing to know is the size of a micron, one millionth of a meter. The , making even the thinnest manes thick and lustrous compared to what doctors like West measure by.

Now, let's look closer at angiograms vs. the latest in OCT resolution. Much closer.

"The resolution of OCT is of the order of 10 microns. So that's really small," West said. "Intravascular ultrasound, an earlier form of such imaging tools, has a resolution of, at best, around 70-100 microns, and then angiography — just the angiogram alone — the resolution is much, much worse, of the order of 200 microns at the absolute best."

To be clear: OCT "gives you 20 times magnification over the angiogram alone," West said.

That clear view is not only of the size of the artery and blockage within it. OCT helps your doctor understand the nature — that is, the composition and calcification (hardness) — of the blockage.

Think of it like plaque on your teeth. Catch it early and it's easier to move. Wait too long and your dentist is scraping hard. It's a similar situation in the arteries carrying blood to the heart. "Some narrowings are very soft and yield very easily when you start to instrument them," West said. "And some are not and require specialized tools to do so."

So while an old-school X-ray of the arteries leading to the heart can give an idea of the size and placement of a blockage that a doctor can review, it's a black-and-white image that leaves an enormous gray area. And that can lead to regret when a stent — too big or, more often, too small, to fix the issue — makes its way to a blockage.

"You stick the stent in and you take a picture and the whole thing looks like an hourglass. It's so pinched in the middle," West said. "And then you realize there was much more calcium in the vessel than you had ever thought. Then you spend the next two hours desperately trying to find a way stretch not only the calcium that was in the vessel wall but also the bit of metal you've put on top of it now, which by the laws of physics, makes it almost impossible to do."

He sympathizes with any doctor who's faced it.

"We've all had that. How do you avoid that?"

The answer is OCT. But even doctors — some of the best-educated among us — can struggle to master it. West knows. He was there when it took off. Remember: Jumbo jet.

"The current OCT screen, there's menus everywhere. There's a menu for this and menu for that," West said. "If you're starting anew — I mean, I started off with OCT when it was literally just an orange circle on the screen, more like piloting a biplane — but I grew up with all these new menus appearing and I knew what to do then.

"But you come to do it today and it's just too confusing."

Confusion does not lead to confidence. And therein lies the crucial question: Could we make OCT work better for patients and their doctors? Or, more to the point, how could we make it work better for all involved?

Meet Nick's friend Max: MLD MAX.

MLD MAX: Shorthand With Long Reach
We know X-rays are lacking, microns are miniscule, OCT is precise but potentially daunting — so much so that some doctors shy away from it since they don't feel expert — how to improve the situation for everyone?

West and other industry experts joined forces a few years ago — brewmasters in an OCT distillery — to reformulate the software and cure what ailed it.

It was barrels of work. But the proof was in the package: .

We'll let West give you the particulars on the ingredients.

"Morphology (the M): So is this vessel calcified, has it got hard plaque in it? What's the length (L) of the narrowing? What's the diameter (D)? You get those three things accurately, you'll make the right decisions in how to treat and how to place your stent," he said.

And now, MAX.

"Once you've put your stent in, you do a second run with the OCT and you get MAX, which is Medial Dissection (M), which is like a tear in the blood vessel wall. 'A' is for apposition, which is: Are all the bits of the stent pushed against the wall?; and 'X' for expansion (of the stent)," West said.

West is rightly proud of how MLD MAX is making OCT accessible in ways it just wasn't before.

"We had this beautiful tool that people weren't using because they didn't know how to interpret the information," West said. "Let's distill this down and try to encourage people just to get the bits of information they need.

". It is trying to give people the information they need rather than bombarding them with everything that this amazingly complex system can churn out. We're just trying to give the physicians what they need to execute that angioplasty."

And the built-in AI?

A strong head topping an honest pour of technology, if you like.

"So the first thing, the AI is there for detection of vascular calcification. That's the hardened narrowings," West said. "People often don't recognize it and that can lead to problems during a procedure, to an increased chance of stents failing. But if we can identify automatically for people, they know when they need to employ particular treatments from the outset, rather than afterward.

"And the second thing is the detection of what we call the external elastic lamina, the true diameter of the vessel. So it enables you to overcome that problem with the angiogram of underestimating the size of a vessel. It detects it and measures it very precisely. And we know that if you use that measurement, that is the best fit for a stent in the vessel."

When every micron matters, Ultreon OCT with AI gets you closer than a hair. A lot closer.

Turn It Up
West is taking us through a quick description of how all this works in the real world, including inserting the OCT catheter — about a millimeter in diameter — to having you on your way in about an hour's time.

"So if you came in for a stent procedure in my lab in Cambridge when I was practicing, you'd walk in, you'd lie on the bed, you'd roll your sleeve up, I'd stick some local anesthetic over the artery in your wrist, the radial artery.

"I would put a plastic tube up your arm into the mouth of your coronary artery, I would squirt in some 'dye', some radiographic contrast, and take some X-ray pictures. I would then put a guidewire in — 14 thousandths of an inch in diameter — right the way from the wrist though that plastic tube down your artery past the narrowing.

"Before I started to try to do anything to the narrowing that I was going to treat, I would run the OCT catheter down, get real-time information — it's practically instantaneous, the processing — that will provide all of that critical information that I've just described.

"And after that, I would be able to make a plan. Then we'd balloon, place a stent, stretch it again with a balloon to high pressure, then we put the OCT down again afterward, have a look, congratulate ourselves on an amazing job and everyone would go home for a cup of tea."

Or maybe some of that craft beer he loves so much. And by the way, you've been awake this whole time.

Make no mistake, whatever he's serving, you'll be glad to have it. It's just what the doctors ordered in , a survey that found physicians view forward-thinking and innovative technologies as critical components to providing the best individualized care.

"And if you're in my lab," West adds, "you can guess you'll be listening to whichever music I was choosing to play."

Of course, doc. Whatever you need to do the job right. It's the same service provides: The information they need to do the job right.

Hope you like the sound of vinyl. Nick West does. The heights of technology work best when everyone can enjoy them, like dropping the needle: The pleasures of enjoying the fullness of a master recording, nothing less … and nothing more.

Who doesn't like the sound of that?

Like this article

IMPORTANT SAFETY INFORMATION

DRAGONFLY OPTIS IMAGING CATHETER

OPTIS IMAGING SYSTEMS AND SOFTWARE

DRAGONFLY OPTIS IMAGING CATHETER

OPTIS SOFTWARE AND APTIVUE E SERIES SOFTWARE

INDICATIONS

The OPTIS Software and AptiVue E Series Software are intended to be used only with compatible OPTIS Imaging Systems.

The OPTIS Imaging System with a compatible Dragonfly Imaging Catheter is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. The compatible Dragonfly Imaging Catheters are intended for use in vessels 2.0 to 3.5 mm in diameter. The compatible Dragonfly Imaging Catheters are not intended for use in the left main coronary artery or in a target vessel which has undergone a previous bypass procedure.

The OPTIS Imaging System is intended for use in the catheterization and related cardiovascular specialty laboratories and will further compute and display various physiological parameters based on the output from one or more electrodes, transducers, or measuring devices. The physician may use the acquired physiological parameters, along with knowledge of patient history, medical expertise and clinical judgment to determine if therapeutic intervention is indicated.

CONTRAINDICATIONS
The OPTIS Integrated System and Mobile System with Software are contraindicated where introduction of any catheter would constitute a threat to patient safety. Contraindications include:

Bacteremia or sepsis
Major coagulation system abnormalities
Patients diagnosed with coronary artery spasm
Patients disqualified for CABG surgery
Patients disqualified for PTCA
Severe hemodynamic instability or shock
Total occlusion
Large thrombus
Acute renal failure

NOTE: The systems have no patient alarm functions. Do not use for cardiac monitoring.

WARNINGS

Appropriate anticoagulant and vasodilator therapy must be used during the procedure as needed.
Observe all advancement and movement of the Dragonfly Imaging Catheter under fluoroscopy. Always advance and withdraw the catheter slowly. Failure to observe device movement fluoroscopically may result in vessel injury or device damage.
Leave the guidewire engaged with the catheter at all times during use. Do not withdraw or advance the guidewire prior to withdrawing the catheter.
If resistance is encountered during advancement or withdrawal of the Dragonfly Imaging Catheter, stop manipulation and evaluate under fluoroscopy. If the cause of resistance cannot be determined or mitigated, carefully remove the catheter and guidewire together.
The Dragonfly Imaging Catheter should never be forced into lumens that are narrower than the catheter body or forced through a tight or heavily calcified lesion.
The Dragonfly Imaging Catheter should not be advanced through abnormally tortuous anatomy.
When advancing or retracting a catheter with a monorail tip through a stented vessel, the catheter may engage the stent between the junction of the Dragonfly Imaging Catheter and guidewire, resulting in entrapment of catheter/guidewire, catheter tip separation, and/or stent dislocation.
Refer to the contrast media’s instructions-for-use for general warnings and precautions relating to use of the contrast media.
To protect the privacy and security of sensitive information, including electronic protected health information (EPHI), and to protect the integrity of the system itself, the system should be located in a physically secure, access controlled environment.
Do not use the OPTIS Imaging System if there is reason to believe the system's security has been compromised or if the system was unaccounted for a period of time (i.e. misappropriated, modified or tampered with).

PRECAUTIONS

Safety and effectiveness have been established for the following patient population: adult patients undergoing non-emergent percutaneous coronary interventions in lesions with reference vessel diameters between 2.0 to 3.5 mm, which were not located in the left main coronary artery or in a target vessel which has undergone previous bypass procedures.
For optimal imaging, only use 100% contrast media.
Store the Dragonfly Imaging Catheter at ambient temperature in a dry location out of direct sunlight.
Never attempt to attach or detach a Dragonfly Imaging Catheter to the DOC while the “lock” LED is lit.
Do not kink, sharply bend, pinch, or crush the Dragonfly Imaging Catheter at any time.
The Dragonfly Imaging Catheter is for single use only. Do not reuse, re-sterilize, or reprocess.
The Dragonfly Imaging Catheter is sterilized by ethylene oxide and is intended for one time use only. Non-pyrogenic. Do not use if the package is opened or damaged.
After use, the Dragonfly Imaging Catheter may be a potential biohazard. Handle and dispose of in accordance with accepted medical practice and applicable laws and regulations.
The Dragonfly Imaging Catheter has no user serviceable parts. Do not attempt to repair or alter any part of the catheter assembly as provided.

DRAGONFLY OPTIS IMAGING CATHETER

INDICATIONS

The Dragonfly OPTIS Imaging Catheter with the OCT Imaging System is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. The Dragonfly OPTIS Imaging Catheter is intended for use in vessels 2.0 to 3.5 mm in diameter. The Dragonfly OPTIS Imaging Catheter is not intended for use in the left main coronary artery or in a target vessel which has undergone a previous bypass procedure.

CONTRAINDICATIONS
Use of the Dragonfly OPTIS Imaging Catheter is contraindicated where introduction of any catheter would constitute a threat to patient safety. Contraindications include:

Bacteremia or sepsis
Major coagulation system abnormalities
Patients disqualified for CABG surgery
Patients disqualified for PTCA
Severe hemodynamic instability or shock
Patients diagnosed with coronary artery spasm
Total occlusion
Large thrombus
Acute renal failure

WARNINGS AND PRECAUTIONS

Store at ambient temperature in a dry location out of direct sunlight.
Ensure the catheter is at room temperature (10°C to 32°C) before use.
This device is sterilized by ethylene oxide and is intended for one time use only. Non-pyrogenic. Do not use if the package is opened or damaged. Do not reuse or re-sterilize.
Appropriate anticoagulant and vasodilator therapy must be used during the procedure as needed.
Observe all advancement and movement of the Dragonfly OPTIS Imaging Catheter under fluoroscopy. Always advance and withdraw the catheter slowly. Failure to observe device movement fluoroscopically may result in vessel injury or device damage. To assure proper placement do not move the guide wire after the Dragonfly OPTIS Imaging Catheter is in place.
If resistance is encountered during advancement or withdrawal of the Dragonfly OPTIS Imaging Catheter, stop manipulation and evaluate under fluoroscopy. If the cause of resistance cannot be determined or mitigated, carefully remove the catheter from the patient.
Use the minimum flush rate and volume required to image the desired anatomy.
After use, this product may be a potential biohazard. Handle and dispose of in accordance with accepted medical practice and applicable laws and regulations.
The instructions for use are recyclable. Dispose of all packaging materials appropriately.
Refer to contrast media Instructions for Use for general warnings and precautions relating to contrast media.
This package contains a Sterile Single Use Only Device. Any attempt to re-use or re-sterilize may compromise the structural integrity of this device.
Do not remove the Dragonfly OPTIS Imaging Catheter from the DOC until the procedure is complete to avoid a potential sterility breach.
Always verify that the catheter has been properly prepared prior to inserting into vasculature.

POTENTIAL ADVERSE EVENTS
The following complications may occur as a consequence of intravascular imaging:

Coronary artery spasm
Unstable angina
Allergic reaction to the contrast media
Arterial dissection, injury or perforation
Thrombus formation, abrupt closure, or total occlusion
Abnormal heart arrhythmias
Embolism
Acute myocardial infarction
Death

OPTIS IMAGING SYSTEMS AND SOFTWARE

INDICATIONS

The OPTIS Software and AptiVue E Series Software are intended to be used only with compatible OPTIS Imaging Systems.

Bacteremia or sepsis
Major coagulation system abnormalities
Patients diagnosed with coronary artery spasm
Patients disqualified for CABG surgery
Patients disqualified for PTCA
Severe hemodynamic instability or shock
Total occlusion
Large thrombus
Acute renal failure

NOTE: The systems have no patient alarm functions. Do not use for cardiac monitoring.

WARNINGS

Appropriate anticoagulant and vasodilator therapy must be used during the procedure as needed.
Observe all advancement and movement of the Dragonfly Imaging Catheter under fluoroscopy. Always advance and withdraw the catheter slowly. Failure to observe device movement fluoroscopically may result in vessel injury or device damage.
Leave the guidewire engaged with the catheter at all times during use. Do not withdraw or advance the guidewire prior to withdrawing the catheter.
If resistance is encountered during advancement or withdrawal of the Dragonfly Imaging Catheter, stop manipulation and evaluate under fluoroscopy. If the cause of resistance cannot be determined or mitigated, carefully remove the catheter and guidewire together.
The Dragonfly Imaging Catheter should never be forced into lumens that are narrower than the catheter body or forced through a tight or heavily calcified lesion.
The Dragonfly Imaging Catheter should not be advanced through abnormally tortuous anatomy.
When advancing or retracting a catheter with a monorail tip through a stented vessel, the catheter may engage the stent between the junction of the Dragonfly Imaging Catheter and guidewire, resulting in entrapment of catheter/guidewire, catheter tip separation, and/or stent dislocation.
Refer to the contrast media’s instructions-for-use for general warnings and precautions relating to use of the contrast media.
To protect the privacy and security of sensitive information, including electronic protected health information (EPHI), and to protect the integrity of the system itself, the system should be located in a physically secure, access controlled environment.
Do not use the OPTIS Imaging System if there is reason to believe the system's security has been compromised or if the system was unaccounted for a period of time (i.e. misappropriated, modified or tampered with).

PRECAUTIONS

Safety and effectiveness have been established for the following patient population: adult patients undergoing non-emergent percutaneous coronary interventions in lesions with reference vessel diameters between 2.0 to 3.5 mm, which were not located in the left main coronary artery or in a target vessel which has undergone previous bypass procedures.
For optimal imaging, only use 100% contrast media.
Store the Dragonfly Imaging Catheter at ambient temperature in a dry location out of direct sunlight.
Never attempt to attach or detach a Dragonfly Imaging Catheter to the DOC while the “lock” LED is lit.
Do not kink, sharply bend, pinch, or crush the Dragonfly Imaging Catheter at any time.
The Dragonfly Imaging Catheter is for single use only. Do not reuse, re-sterilize, or reprocess.
The Dragonfly Imaging Catheter is sterilized by ethylene oxide and is intended for one time use only. Non-pyrogenic. Do not use if the package is opened or damaged.
After use, the Dragonfly Imaging Catheter may be a potential biohazard. Handle and dispose of in accordance with accepted medical practice and applicable laws and regulations.
The Dragonfly Imaging Catheter has no user serviceable parts. Do not attempt to repair or alter any part of the catheter assembly as provided.

DRAGONFLY OPTIS IMAGING CATHETER

INDICATIONS

CONTRAINDICATIONS
Use of the Dragonfly OPTIS Imaging Catheter is contraindicated where introduction of any catheter would constitute a threat to patient safety. Contraindications include:

Bacteremia or sepsis
Major coagulation system abnormalities
Patients disqualified for CABG surgery
Patients disqualified for PTCA
Severe hemodynamic instability or shock
Patients diagnosed with coronary artery spasm
Total occlusion
Large thrombus
Acute renal failure

WARNINGS AND PRECAUTIONS

Store at ambient temperature in a dry location out of direct sunlight.
Ensure the catheter is at room temperature (10°C to 32°C) before use.
This device is sterilized by ethylene oxide and is intended for one time use only. Non-pyrogenic. Do not use if the package is opened or damaged. Do not reuse or re-sterilize.
Appropriate anticoagulant and vasodilator therapy must be used during the procedure as needed.
Observe all advancement and movement of the Dragonfly OPTIS Imaging Catheter under fluoroscopy. Always advance and withdraw the catheter slowly. Failure to observe device movement fluoroscopically may result in vessel injury or device damage. To assure proper placement do not move the guide wire after the Dragonfly OPTIS Imaging Catheter is in place.
If resistance is encountered during advancement or withdrawal of the Dragonfly OPTIS Imaging Catheter, stop manipulation and evaluate under fluoroscopy. If the cause of resistance cannot be determined or mitigated, carefully remove the catheter from the patient.
Use the minimum flush rate and volume required to image the desired anatomy.
After use, this product may be a potential biohazard. Handle and dispose of in accordance with accepted medical practice and applicable laws and regulations.
The instructions for use are recyclable. Dispose of all packaging materials appropriately.
Refer to contrast media Instructions for Use for general warnings and precautions relating to contrast media.
This package contains a Sterile Single Use Only Device. Any attempt to re-use or re-sterilize may compromise the structural integrity of this device.
Do not remove the Dragonfly OPTIS Imaging Catheter from the DOC until the procedure is complete to avoid a potential sterility breach.
Always verify that the catheter has been properly prepared prior to inserting into vasculature.

POTENTIAL ADVERSE EVENTS
The following complications may occur as a consequence of intravascular imaging:

Coronary artery spasm
Unstable angina
Allergic reaction to the contrast media
Arterial dissection, injury or perforation
Thrombus formation, abrupt closure, or total occlusion
Abnormal heart arrhythmias
Embolism
Acute myocardial infarction
Death

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