my pleasure bill present to you today
data on the radiance hc and trio
specifically many of you be aware that
real generation is being studied for the
treatment of hypertension it's a device space
therapy to treat high blood pressure why
do we need a device beeps therapy
when we have so many medications that
work well unfortunately
the for many patients those medications don't
get patients to the goal because i'm
of a variety of reasons summer relates
to access to care so relaxed of
side effects to medications but suffice it
to say that there's a large number
of people that still have control blood
pressure to what we sought to do
and the specific study is to take
patience and put them on steroids
care regimen and at his three separate
medications all guideline directed to lower blood
pressure and then if their blood pressure's
were still elevated to then randomly assign
them to real innovation versus a sham
procedure what real innovation aims to do
is it aims to sort of zap
the nerves that are around the kidneys
and so therefore reducing blood pressure
and has been shown and other studies
to reduce blood pressure more than a
sham or a placebo procedure the what
hadn't been not studied is this type
of populations for patients that are already
on this to repeal combination and then
to see if their blood pressure to
be lowered and a two months we
certainly showed that there was a lower
blood pressure in the patients who had
been assigned to the derivation therapy
he compared to those it was time
to the sham of the placebo procedure
but beyond that will we aim to
do is to see what the effect
was with further medication and derivation compared
to further their medication plus sham are
fake procedure and so between months to
and six we added back medicines if
the blood pressure still remained elevated and
the doctor
so we're doing that actually didn't know
which arm of the study do patients
were initially whether they been randomly assigned
to generation vs sham and what we
showed is that bitch pre months to
and six there were less medications added
back to the generation group compared to
the champ group such dusting again the
not only with generation effect of a
two month but that it was effect
out
six months and that's the data that
we presented out at the end of
last year
there are several questions that colleagues will
ask about studies like this one i
think the first one as well what's
the role of the innovation when we
already have medication has to treat blood
pressure for me the answer that really
stems from the fact that we still
have patients in the office in my
own clinical practice who despite our best
efforts to is to medication still have
elevated blood
pressure and so for me this is
a type of procedure if it were
ultimately prove that would give those patients
an option to further lower their blood
pressure thereby hopefully reducing their rates of
adverts cardiovascular events other questions they ask
is is this procedure generalizable well it
turns out that there were a lot
of patients that we screened for the
study
that still had elevated blood pressure's and
that was despite the fact that we
instituted this medication regimen of the three
drug combination pills but on the other
hand the rude deathly patients we screen
and had elevated blood pressure's and we
put them on the single combination pill
and the blood pressure's became more controlled
so would i would say is that
the journalism billy lives and trying to
emulate this
i the design in which i mean
that patients really should be tried on
best medical therapies lifestyle intervention exercise all
those things that they still are resistant
are still have elevated blood pressure's and
innovation could be an option the final
question i guess i could addresses what's
the procedure like and along as a
tape is relatively strict straightforward procedure and
up
asian procedure the with this device specifically
the derivation of tends to be three
ablation each about seven seconds on each
side to the overall generation is about
forty five seconds the overall procedural time
is less than forty five minutes for
most patients and then they go home
that the same day
and i guess i guess the final
question would be as and durable a
how long is this affect the for
and we need further data to be
honest answer those types of questions
to me this data will affect on
today because in some respects it changes
the mindset of what many people felt
about real generation in other words many
people but it didn't work and i've
heard from many colleagues that after seeing
data from really and safety and trio
in conjunction with radiance solo and also
trials from the metallic program the spiral
program that they do
you believe that real and innovation works
is the it affect his greatest it
was touted say five ten years ago
know it's not that great but it's
certainly works and it can work in
conjunction with or at the scene medical
therapy
for the next steps for this specific
research program are several the first is
longer term follow up from the study
and radio station solo we really want
to make sure that this affair can
be durable over time in addition we
have an ongoing study called radiance to
which is the pivotal us study on
the wall fleet be the basis for
for on a submission to the ft
a for device approval that study still
ongoing were actually completing the roman eminently
and we hope to go to present
the data in the second quarter sorry
second half of twenty twenty two there
are also other programs that have trials
that are coming out and we need
amalgamate those data to get other to
be able to fill up figure out
what the best role is for real
dinner
nation in patients that have on patrol
blood pressure
in closing i think the take away
point is that real innovation can work
to lower blood pressure not only does
it work by itself but it works
in conjunction or synergistically i'm relatively with
medications it can be used to treat
it for clinicians were trying to take
care of patients i think with good
news here is it the this offers
another tool in the tool
box treat blood pressure we need to
be good doctors we need to emphasize
to patients the importance of taking their
medications the importance of lifestyle modification spam
diet modification and all those things the
and help the lower the cardiovascular risk
but if those things don't work or
if they are unwilling to try those
things then we hope in the near
future to have another thing
therapy such as real innovation that can
help them lower their blood pressure and
hopefully their partner vascular risk