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About the ClariVein ®
Catheter
ClariVein® is a simple-to-use, minimally invasive, small
caliber (2 ⅔ French), soft, flexible, battery-powered
infusion catheter designed to treat peripheral
vascular diseases such as varicose veins.
The ClariVein® system is used to treat the root cause of
varicose veins. Through the use of targeted and well
dispersed delivery of a drug, combined with a rotating
tip which agitates the internal lining of the vein, very
effective results are achieved and the vein is closed
down.
Infusion catheters are used in a variety of procedures to
infuse a drug directly to a treatment site. They allow for
direct, highly controllable, and concentrated treatment,
minimizing the toxicity of systemic administration
while increasing therapeutic efficacy, yield, and safety.
The ClariVein® catheter is a product of Vascular
Insights LLC of Madison, CT. The company engages in
the design, development, manufacture, and marketing
of medical devices for the minimally invasive treatment
of peripheral vascular disease.
Vascular Insights has received 510(k) clearance from
the U.S. Food and Drug Administration to market its
ClariVein® infusion catheter for infusion of physicianspecified
agents in the peripheral vasculature and it
has CE approval for international use.
www.clarivein.eu
The Unique ClariVein ® Catheter for
the treatment of varicose veins.
ClariVein ® is a special catheter with a rotating tip.
It promotes controlled, well dispersed and effective
drug coverage of the targeted treatment area to treat
varicose veins.
It does this with no pain and minimal discomfort
or bruising. No tumescent anaesthesia is needed
therefore there are no multiple injections. Due to
there being no thermal (heat) energy used in the
procedure, there is no risk of nerve damage; there are
reduced risks over other treatment options.
ClariVein offers a safe and effective treatment for
varicose veins.
www.spirebushey.com
EMEDD
UK distribution by Emedd Technology
www.emedd-tech.com
Spire Bushey Hospital
Heathbourne Road
Bushey, Hertfordshire
WD23 1RD
T: 020 8901 5505
PMS 2617
79/100/0/15
swish = 40% tint
ClariVein ® is the new technique for the
treatment of varicose veins
> Safe & effective
> Pain free with minimal discomfort
> No tumescent anaesthetic & no multiple
injections
> No internal leg pressure
> Rapid return to normal activities
> Minimal bruising, or none at all
> Reduced risks
> No risk of thermal damage from laser or RF energy
> No risk of nerve injury

HeAlTHy VeIn VAlVeS & CorreCT blood flow dAmAged VeIn VAlVe & InCorreCT blood flow
How do I know If I HAVe A VeIn problem?
Using ClariVein ®
to Treat the Source of Varicose Veins
Many people have visible abnormal veins. These may be spider veins or
bulging varicose veins. Others have complications of vein disease, such as
darkened or damaged skin around the ankles, open ankle ulcers, phlebitis,
or blood clots. Symptoms can include aching, throbbing, swelling or
heaviness that is worse at the end of the day.
How IS ClariVein ® USed To TreAT VArICoSe VeInS?
ClariVein® is a special catheter with a rotating tip. It is two
to three times thinner than the current devices used in
radiofrequency and laser treatments.
The ClariVein® catheter treats the abnormal feeding vein
that is the underlying cause of visible bulging varicose
veins. The procedure with ClariVein® is minimally invasive and takes less
than 30 minutes.
Here are the steps involved:
> Ultrasound visualizes the vein to be treated.
> After a local anaesthetic is applied, the special ClariVein®
catheter is inserted through a tiny entry point and threaded along the
length of the vein to be treated.
> No anaesthetic (tumescent anesthesia) is required along the length of the
vein.
> The rotating tip of the ClariVein catheter is set in motion. The tip
sensitises and damages the lining of the vein (the endothelium).
> The catheter is pulled down the vein with the tip rotating, and
simultaneously a sclerosant drug is sprayed from the end of the catheter
which causes the vein to close (occlude).
> The leg is wrapped in a compression bandage following
the procedure.
> Normal activities can be resumed rapidly after the procedure.
> If there is any minor soreness or bruising it can be treated with over-thecounter
non-aspirin pain relievers as needed.
wHAT HAppenS If I leAVe my VeInS UnTreATed?
Vein disease never gets better. It will only stay the same or get
worse. Most people seek treatment to improve symptoms, improve
appearance, or prevent future complications.
wIll TreATmenT of my VeInS reqUIre mAny dAyS AwAy
from work And oTHer dAIly ACTIVITIeS?
No. You should be able to resume normal activities immediately
after treatment with the ClariVein® catheter.
IS THe proCedUre pAInfUl?
No. The ClariVein® catheter is inserted through a needle-sized
entrance point. During the treatment of the vein little or no
sensation should be felt.
How doeS THe proCedUre USIng ClariVein ® CompAre wITH
AlTernATIVe ApproACHeS To TreATIng VArICoSe VeInS?
During vein stripping, multiple incisions are made in the groin
and calf, and a stripper tool pulls the vein from the leg. Performed under general
anaesthesia in a hospital operating room, this approach typically results in postprocedure
pain and bruising.
During radiofrequency or laser ablations treatments, tumescent anaesthesia is
used to protect the surrounding tissue. In addition to the multiple injections
required, this causes internal pressure on the leg which is uncomfortable. As
these techniques use heat to damage and close the vein, they can result in
significant pain and bruising both during and after the procedure.
The procedure using ClariVein® requires insertion only of a thin catheter, not a
large vascular sheath. The rotating tip of the ClariVein® device, combined with
the targeted delivery of the sclerosant drug are used to occlude the vein. No
tumescent anaesthetic is required, and hence there are no multiple injections, no
internal leg pressure, no chance of nerve injury, or pain and bruising as a result of
heat energy or surgical procedures.
ClariVein® is a new technique so long term follow up of patients is not yet
available to compare the results with Laser or RF over periods of longer than
one year. Published data so far suggests that ClariVein® is as effective as these
techniques at the 6 month and the 12 month stage after treatment, and further
follow up of cases is needed to assess effectiveness in the longer term - this
information will be published in the open medical literature as we acquire it.
wHAT HAppenS To blood flow AfTer THe dISeASed VeIn
IS CloSed down (oCClUded)?
The abnormal vein that was ablated was not functioning correctly
prior to treatment. It was the cause of your vein problem. Once
the abnormal vein is treated, blood is re-routed to your normally
functioning veins.
wHAT If I need THe VeIn for bypASS SUrgery In THe fUTUre?
Since the treated vein was diseased – weakened and dilated – it
could not be used in a bypass procedure.
How IT workS!
1
2
3
The Clarivein catheter is introduced into the vein
to be treated under ultrasound guidance. This is
done through a tiny access point and the catheter
is threaded along the length of vein to be treated.
No tumescent anaesthesia is required.
Once in the correct position, the rotating tip of
the catheter is set in motion which sensitises and
damages the lining of the vein. At the same time,
a sclerosant drug is sprayed from the tip of the
catheter and causes the vein to close. The device
is pulled back along the vein to treat the full
length required.
After short procedure is complete, patient returns to
normal activity the same day.