Interviewer: - better or what the impact of using this.

Respondent: This feels like it takes less time with your foot on the pedal trying to control
leading from a vessel with that.

Interviewer: Okay.

Respondent: As far as the hand case themselves, the way the cord comes out the end is
important for how much it feels heavy in the back of the forceps against the crease
of your hand and that affects the way everything feels balanced. I think the Stryker
ones do a better job with that than the IsoCool like what I was saying.

Interviewer: You’re talking about what’s coming if you can see where my pointer is right here.
What happens off of here and how weighty it is or bulky its impact in what the
instrument feels like.

Respondent: Yes.

Interviewer: Just so I’m clear, you’re using a Stryker Generator with this [special] Stryker
mallet. This - [Crosstalk]

Respondent: I think we’ve plugged that into a separate Stryker Generator, as far as I can recall.

Interviewer: We’ve been building off what we’ve been talking about. A number of the folks I’ve
talked to over the past week have talked about an issue they call thermal spread
and I’m curious when you hear that phrasing, what does that mean to you? is that a
meaningful expression? What is it?

Respondent: There are two aspects to that. It basically means that you want to confine between
the tips of the blades. It gets dissipated and spread to adjacent areas so that
could, number one, reduce the efficacy of what you’re trying to cauterize between

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 the tips and so there’s ongoing bleeding but there could also be injury to
surrounding areas from local heating.

Interviewer: Okay.

Respondent: I think -

Interviewer: Is thermal spread – yes, keep going.

Respondent: I was just going to say we’ve had just considered that inevitable element of things
so we don’t really look at it so much as an unmet need because I guess I don’t
know that anyone is going to do much about it.

Interviewer: Is thermal spread always a bad thing that you’re trying to avoid?

Respondent: If we use that definition that I described, then I think so because there is really no
benefit to having the current and the heat go outside of the space between the two
blades. If you have missed the target with your forceps blades, the thermal spread
isn’t going to miraculously stop the bleeding that’s coming from a different
location. The only thing that it would do is undermine the control of bleeding from
what’s between your tips.

Interviewer: I’m curious. In your experience, you’ve used the [special] mallet a lot. You’ve used
the IsoCool. You’re aware of the [Kojis]. Even if you’re thinking of reusables as
well, I’ll broaden this question. In your experience with any kind of bipolar forceps,
do you see differences in the thermal spread with one brand versus another or are
they all equal or somewhere in between? You tell me.

Respondent: That’s not a feature I typically think of as distinguishing one handset from another,
no.

Interviewer: Is it like you’re not even paying attention to that because, like you said, it’s
inevitable so I’m expecting it or is it more like I don’t think there are going to be
differences?

Respondent: I don’t think that is the biggest unmet need within their design and so I don’t really
pay attention to it a lot. I think if I’m not expecting that stopping the bleeding

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 between my tip blades, there are a lot of potential explanations including thermal
spread but also maybe I haven’t brought the tip blade close enough together.
These blades are not completely parallel so there’s a limited portion where the tips
can actually make contact with one another because they’re at an angle so
sometimes, you think that you have the vessel of interest in between the two
blades but the depth of your forceps maybe such that where the two blades
connect just below the vessel and so you’re not getting as much spread between
the two blades but you’d have to withdraw the forceps a little bit so that the tips
actually make contact with the vessel itself. I suppose in that sense the thermal
spread would potentially be a little bit beneficial because you’ve missed the -
[Crosstalk]

Interviewer: Your target area?

Respondent: Yes, but it’s not going to help it if the vessel is on either side of the blade. It still
has to be in between the two blades.

Interviewer: The risks of thermal spread are two-fold in broad strokes. One is you’re not going
to cauterize as well the intended spot that you’re trying to cauterize the other is
you may heat up surrounding areas?

Respondent: Which is rarely - [Crosstalk]

Interviewer: I get what – go ahead.

Respondent: It’s really not relevant for the majority of the locations where we’re operating
except some critical nerves like the optic nerve that’s often near the proximal
internal carotid artery but when we’re not around the optic nerve, I don’t think we
worry too much about the thermal spread because the irrigation serves a few
purposes. One is to keep the forceps from sticking and charring to tissue. The
second is, if the drop hits in between the two blades and that helps cauterize that
and the third is to provide a heat sink that prevents the adjacent tissue from
getting too hot.

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Interviewer: I’m hearing a number of things that you as a practitioner and surgeon can do to
minimize thermal spread. You can irrigate. It’s how you position the tips. Are there
other things that you’re doing to - [Crosstalk]

Respondent: Just being cognizant of where you’re at, like I said, if we’re around the optic
nerve, we’re a lot more worried about that than in other locations.

Interviewer: So if we go back to the page with your key procedures and talking specifically
about this idea of thermal spread and when you’re most concerned, which, if any,
of these procedures, broadly speaking, are going to be the ones that you worry
about? Obviously, the optic nerve but like you said –

Respondent: The [Unintelligible] mostly with aneurysms.

Interviewer: Okay.

Respondent: For one reason, when we’re operating on aneurysms, we’re usually within the
subarachnoid space and we’re not actually entering into the brain parenchyma
whereas with the brain tumor and with an AVM, we often are so to that extent,
we’ve already probably violated the brain to some extent so thermal spread would
not be beyond the pale the way it might be with an aneurysm where you’re,
strictly speaking, outside the bran parenchyma.

Interviewer: How big an issue or how significant a consideration is thermal spread in the
procedures that you’re doing?

Respondent: Until our discussion, I really didn’t think of it as much a barrier or impediment.

Interviewer: Is that because the risks aren’t that great or because you know what to do to
control for it or something else?

Respondent: I think a combination.

Interviewer: Tell me about it in your eyes. Thermal spread is not a big deal because –

Respondent: That’s been discussed. Aside from certain –

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Interviewer: I know sometimes I ask you to repeat yourself.

Respondent: No, aside from certain locations, it probably is not very injurious. Also, that can be
used to mitigate that including judicious irrigation and just being mindful of where
we’re operating.

Interviewer: Got it. How do you know when thermal spread is happening? What are the cues?
What are the metrics? What are the signs, if any?

Respondent: If we find little levels in the tissue adjacent to where we’re working and we see
that after our cauteries, those no longer fill, then that would be indirect evidence
that we’ve inadvertently cauterized those vessels as well and if those vessels were
either side of the blades and not in between the two blades, then that would be an
unintended area of collateral damage. Otherwise, there’s no way of knowing really
because with the patient still asleep, until the patient wakes up we don’t know. If
the patient does wake up with some impairment, I’ll give you the example of the

visual impairment. If we were near the optic nerve, we never know if that occurred
as a result of thermal spread from our bipolar around there or maybe, it occurred
because when we were drilling the adjacent bone, there was some pressure placed
on it or any host of other potential explanations. Other than just seeing the vessels
adjacent to the area where you’re working starting to show evidence that you
unintentionally cauterized them, I don’t know a way of confirming the thermal
spread. It’s a big problem and then, of course, just the decreased efficacy of the
cauterization in between your blades. If you aren’t effective at cauterizing the
vessel, that might be because of thermal spread too.

Interviewer: Let me play it back and make sure I’m understanding it. In terms of knowing when
this is happening or not, to a large extent you don’t. You may see something. You
may see unintended coagulation of ancillary vessels. You’re also looking to see any
negative outcomes for patients like visual impairment. You won’t know those right
away and even if you do see those, the jury is out on whether it was the bipolar
that did that or something else related to the procedure. It sounds like there is
some gray area. Am I hearing that right?

Respondent: Yes.

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Interviewer: I’m also hearing that’s okay. Like you said a few times, this is not a big unmet need
area for me. We’re doing okay. We have things [Unintelligible].

Respondent: Yes, and also because that’s one of the purposes of irrigation, to act as the sink
that limits that.

Interviewer: If a manufacturer or sales rep came in and they said “We’ve got a new disposable
bipolar that reduces thermal spread,” would that get your attention?

Respondent: I think it would be something that we would consider a favorable attribute but I
don’t think it would be the number one priority and I think if there were other
things about it that made it an unacceptable tradeoff like I didn’t like the way the
ergonomics felt in my hand or the cost was prohibitive or some other thing, I think
it would be more of a bench science advantage rather than a practical advantage.

Interviewer: Got it. In the scope of the trade-offs you’re making when you’re choosing specific
instrumentation, thermal spread is not at the top of the list, right?

Respondent: Right.

Interviewer: The ergonomics matters more and cost matters more.

Respondent: Yes.

Interviewer: Okay, I want to show you a couple of thermal images and for the sake of this
discussion – I don’t know where exactly this came from. It’s some sort of bench
research sort of thing and you’re going to see two thermal images both of which
are showing disposable bipolar forceps in action. Assume for the moment that what
you see on the left is what you’re using and what you see on the right is a new
version. I want to know first as you look at these images, just describe for me what
it is you’re seeing?

Respondent: We’re seeing a profile of the bipolar shaft and the blades and a color coded map of
the temperature that’s generated both between the blades and in a halo of
surrounding tissue so comparing the two different devices, it seems that the one of
the left has a higher temperature range in between the tips over a broader area.
The one on the right to seems to confine the highest temperature to a spot right
where you intend it which is within the forceps blades as opposed to beyond or just

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 close to it so that looks to be a much more favorable profile of what you’re
achieving. Like I was saying, sometimes that by itself is not directly pinched by
your forceps tips because they’re not parallel. They come at a little angle. If
you’re a little too deep, it may be helpful to have the heat of the current be a
little bit more proximal within it. This would imply that you have the same degree
of effectiveness in that scenario. Now, if you’re too shallow, maybe the one on the
left is better because you do want a little bit of heat and spread deep beyond your
forceps but the overall impression I’m seeing is the one on the right is more
precise.

Interviewer: Is this meaningful to you as a surgeon? Is it showing you something that you would
like?

Respondent: Yes, like I said, if everything else were equal, I don’t know why anyone would
deliberately choose the one on the left.

Interviewer: Again, that is if all else was equal, right? You’ve already talked to me about some
of the issues that, in some ways, matter to you, the handling in particular, the
ergonomic feel for you.

Respondent: Yes, there may be an issue of cost and/or reliability and accessibility.

Interviewer: If what you’re seeing here is a story that this new version reduces thermal spread
by one millimeter, what’s your reaction to that?

Respondent: Given the inherent precision of what we’re doing, one millimeter is significant. I
think hearing the term “one millimeter” may not be as compelling as seeing this
image.

Interviewer: Okay, so if I had a little caption here that said “This new disposable bipolar forceps
reduces spread by one millimeter,” you’re still paying more attention to the photo
than you are to the caption?

Respondent: Yes, I think so. I think that one millimeter stands so trivial and minimal, even
recognizing how precise our maneuvers are but I think this picture tells the story
much better.

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Interviewer: As you’ve been describing, we’re talking about very small areas and need for a lot
of precision. What does one millimeter represent in your world? Help me
understand when they say “one millimeter,” what does that equate to in the scale
of what you’re working?

Respondent: We’d like to think that one millimeter means a lot but there are other
circumstances where one millimeter difference is very meaningful specifically
when I’m doing intravascular procedures with little catheters inside the arteries
but when we’re outside of the vessels and doing open surgery, one millimeter is a
much less meaningful discriminating feature because I don’t think you can be as
precise. Already this thing is 30-inches beyond our elbow or something so if you’re
telling me that controlling your arms so that you’re one millimeter deeper or more
shallow, that’s a hard proposition to claim that it’s as meaningful.

Interviewer: For the sake of argument, instead of saying it reduces thermal spread by one
millimeter, if they said it reduces it by five millimeters?

Respondent: I think that’s getting more into range of what’s meaningful because I think that the
tips themselves are five millimeter diameter.

Interviewer: Got it. Keep going with that. Connect those dots and that sort. If the tips are five
millimeters in diameter –

Respondent: Relative to the blades themselves, you’re getting reduction in spread that’s the full
dimension of the blade. It’s actually not five millimeters. It’s one millimeter thick
but they’re five millimeters long.

Interviewer: Okay.

Respondent: One millimeter is the width but the length of the exposed blade is more like five
millimeters so that’s where five millimeters would be a much more meaningful
comparison than one millimeter.

Interviewer: Let’s put aside the one millimeter and the five millimeter and, as you said, the
image is really telling a story for you. That’s the compelling part. Based on what
they’re showing you here in this comparison, if I went back to the chart you
showed me before and I said the hospital is going to bring this particular bipolar

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 forceps and you can use it in the [ORC] you’re working in now, do you think it
would change any of these numbers? If I put in new disposable down here at the
bottom, might I take away from the 30 Stryker [Spencer mallet] that you used
[Unintelligible] for the 50 that you do for aneurysms or the [Unintelligible] brain
tumor insertions and so on? If so, by how much?

Respondent: This is assuming that everything else feels the same?

Interviewer: Yes, and I didn’t say that before but assume, for the sake of argument, that the
ergonomics feel equivalent in all the other ways.

Respondent: The cost is comparable. Then, I don’t know why anyone would deliberately choose
the first one. I think it would replace all.

Interviewer: As a follow-up question, what I’ve been told is that, on average, a disposable
bipolar forceps is $300.00.

Respondent: I think that’s definitely acceptable.

Interviewer: if this new version was $400.00 or $450.00 where the average is $300.00, what sort
of reactions do you have with that product?

Respondent: I think it would be justifiable and I think that it would not be a deal breaker.
Obviously, by percentage, you’re talking up to 50% more and that’s what the
[Crosstalk] but when you think of the total cost of all of the devices for an
operation in the tens of thousands of dollars, it’s a trivial difference. I mean these
[Unintelligible] have been out for more than a decade so I think people would be
receptive to an idea that there’s something that’s new technology.

Interviewer: Okay.

Respondent: I think the marketing of this new device should capitalize on that notion too.

Interviewer: Yes, that there hasn’t been a lot of innovations in a static category. Am I hearing
that right?

Respondent: Yes.

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Interviewer: Imagine that you give these a shot. You get a pair of them. You’ve got access to
the new trials and a few cases. How would you judge whether they are enough of
an advantage that it’s easily justifiable cost-wise if in fact - [Crosstalk]

Respondent: I think you would need to try them in at least half a dozen cases firsthand because
one or two cases here and there is not going to be enough experience to make a
conclusion about its enhanced efficacy.

Interviewer: Let’s say we do six cases. How are you going to assess the difference? After those
when you sit back and say “Is it worth it to push for these to be available?,” what
are you going to be - [Crosstalk]

Respondent: It’s going to be a very subjective thing. At the end, you say how did this feel
compared to my experience but there’s so much variability from patient to patient
that could account for why one day the instrument seems to be working better
than on a different day and that’s just how tough the AMV or something like that.
We’ve been focusing mainly on the cautery aspect of it now but the section aspect
needs to be just as important with that. As far as making it not too sharp like the

IsoCools where you’re worried about cutting things, those are very pointy tips. The
other ones are more blunt and rounded tips so I think that has to be comparable
throughout.

Interviewer: Terrific, I have one more thing I want to do with you and we’re going to do it
quickly. This is one at a time. We talked to neurosurgeons for a number of projects
over time and what you see here are statements that basically paraphrase some of
the things we’ve heard from some neurosurgeons and I want to get a sense of how
these statements align with your own personal perspective so you can tell me on a
scale of +3 to -3 how much you agree with each statement. You can choose any
number between the range so the first statement is “I take published data into
consideration when deciding which bipolar forceps I use.” How much would you say
you agree or disagree?

Respondent: +1.

Interviewer: Are there published data about bipolars?

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Respondent: I’m sure there are but I haven’t read it.

Interviewer: Got it. “All bipolar forceps are the same?” Do you agree?

Respondent: -2.

Interviewer: It certainly reflects what you’ve been telling me in the conversation. The next one,
“It doesn’t matter which forceps you use. They’re going to stick regardless.”

Respondent: -1.

Interviewer: Yes, you did talk about sticking issues before and it sounded like, to a certain
extent, a universal issue but I’m also seeing from that number but some are better
than others.

Respondent: Yes, I think so.

Interviewer: Just remind me from the ones we’ve talked about, which are the ones that you
view as particularly prone to – we’re talking about the disposables.

Respondent: My experience over the last decade has been really limited to the one brand. It’s
hard to compare them as far as their [Unintelligible]. I’m just thinking when I did
use IsoCool. [Unintelligible] not a fan.

Interviewer: They were sticking. Some were sticking.

Respondent: I don’t remember if they were or not. I just didn’t like them enough to try them,
enough time to say that they were more sticky or not and [Crosstalk] aspects of
them.

Interviewer: The feel and the pointiness.

Respondent: Yes.

Interviewer: The next statement is “I believe I can control collateral tissue damage when
coagulating tissue with bipolar forceps.”

Respondent: I’d say +2.

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Interviewer: Yes, which is a topic we’ve talked about already so I understand that. “I use a
particular forceps when minimizing thermal spread is of the utmost importance
during a case.”

Respondent: Zero, I don’t have a strong reaction about that. First of all, we only use type of
disposable and that’s guided more just by the intrinsic performance of the case and
not because it’s spread concern.

Interviewer: I’m also hearing from you that there are other things you are doing in certain cases
to minimize the risk of thermal spread when you are particularly concerned but you
engaged in doing one of those things, right?

Respondent: Yes.

Interviewer: Next one, “Thermal spread is not an issue that affects my cases.”

Respondent: Let’s say +1.

Interviewer: Finally, “The ideal disposable bipolar forceps exists.”

Respondent: I’ll say +1. I think the Spencer mallet comes a long way but I’m sure it could be
better.

Interviewer: Terrific. Doctor, I have kept you over by a couple of minutes. Thank you.
[Unintelligible] through all the questions I wanted to ask you and I really appreciate
you taking the time to do this and for all the insights you’ve given me. It’s really
been valuable.

Respondent: I hope it helps. Good luck on your research.

Interviewer: Thank you so much. Have a great rest of your day.

Respondent: You too, thanks. Take care, bye.

Interviewer: Bye bye.

- End of Recording -

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