Precautions Applicable To All Indications; Instructions For Use - Boston Scientific Contour Mode D'emploi

• Serious radiation induced skin injury may occur to the patient due to long periods
of fluoroscopic exposure, large patient diameter, angled x-ray projections, and
multiple image recording runs or radiographs. Refer to your facility's institutional
protocol to ensure the proper radiation dose is applied for each specific type of
procedure performed. Physicians should monitor patients that may be at risk.
• Onset of radiation-induced injury to the patient may be delayed. Patients should
be counseled on potential radiation side effects and whom they should contact if
they show symptoms.

PrECaUTIOnS aPPlICablE TO all InDICaTIOnS

• Patients with known allergy to contrast medium may require pre-medication prior
to embolization.
• Additional evaluations or precautions may be necessary in managing
periprocedural care for patients with the following conditions:
A. Bleeding diathesis or hypercoagulative state;
B. Immunocompromised.
• Sterile and single use product. Never reuse a vial that has been opened. Do not
use if the vial, screw cap, or tray package appears damaged.
• Ensure cleanliness and attention to technique during preparation of the device to
avoid introducing contaminants.
• The appropriate size particles must be chosen based upon the lesion to be treated
and the measurements taken from the baseline angiography.
• The use of sophisticated imaging equipment is necessary for successful
embolization therapy.
• Appropriate facilities should be available to treat potential complications of the
procedure.
• While it is anticipated that long-term embolization of vascular structures with
Contour™ Embolization Particles will be achieved, no guarantee of permanence,
cure or benefit can be made.
UfE Specific warnings for Pregnancy (Specific for Treatment of leiomyoma Uteri)
• UFE is not intended for women who desire future pregnancy. The effects of UFE on
the ability to become pregnant and carry a fetus to term, and on the development
of the fetus, have not been determined. Therefore, this procedure should only be
performed on women who do not intend future pregnancy.
• Women who become pregnant following UFE, should be aware that they may be at
increased risk for preterm delivery, cesarean delivery, malpresentation (incorrect
positioning of the baby), and postpartum hemorrhage (post-delivery bleeding).
• Devascularization of uterine myometrium resulting from UFE may put women
who become pregnant following UFE at increased risk of uterine rupture.
Other UfE Specific warnings
• Do not use particles smaller than 355 microns.
• An appropriate gynecologic work-up should be performed on all patients
presenting for embolization of uterine fibroids (e.g., endometrial sampling to rule
out carcinoma for patients with abnormal bleeding).
• Devascularization of uterine myometrium resulting from UFE may put women at
increased risk of uterine rupture.
• The diagnosis of uterine sarcoma could be delayed by taking a non-surgical
approach (such as UFE), to treat uterine fibroids. Conduct a more thorough
work-up for patients with warning signs for sarcoma (e.g., prior pelvic radiation,
MRI findings, rapid tumor growth, postmenopausal with new uterine enlargement).
Recurrent or continued tumor growth following UFE should be considered a
potential warning sign for sarcoma and surgery should be considered.
UfE Specific Precautions
• It is recommended that patients undergoing embolization of leiomyoma uteri be
provided a clear understanding of who will provide post-procedure care prior to
the embolization procedure.
• UFE should only be performed by physicians who have received appropriate
training for treatment of uterine leiomyomata (fibroids).
• There is an increased chance of retro-migration of Contour Embolization Particles
into unintended blood vessels as uterine artery flow diminishes. Embolization
should be stopped when the vasculature surrounding the fibroid can no longer
be visualized but before complete stasis in the uterine artery.

InSTrUCTIOnS fOr USE

1. Inspect packaging prior to use to ensure seal integrity for maintenance of sterility.
2. Access the femoral artery using the standard Seldinger technique. Insert the
valved sheath of choice to aid in control of arterial backflow.
3. Perform baseline angiographic evaluation of vascular network associated with the
target lesion prior to beginning embolization procedure.
4. Choose appropriate Contour Embolization Particle size based on clinical
presentation including vascular target/vessel size and desired clinical outcome.
5. Choose appropriate delivery catheter per standard protocol.
6. Under fluoroscopy, advance the delivery catheter to the desired lesion according
to standard technique.
Inject contrast agent through the delivery catheter to confirm position and flow.
7. Open Contour Embolization Particles vial and pour contents into sterile container
(e.g., bowl or barrel of a syringe).
Mix contents of one vial of Contour Embolization Particles with contrast agent/
saline to form a dilute solution.
Agitate by inverting syringe several times or gently use back-and-forth agitation
through a stopcock or stir mixture in bowl.
If using syringe method, continue to next step. If using mixing bowl method:
Draw the solution into delivery syringe. If a 3-way stop-cock delivery method is
preferred, draw solution into "reservoir" syringe first. Ensure that all air is purged
from the system prior to injection. Connect the reservoir syringe and/or delivery
syringe as appropriate to the stop-cock and/or catheter. Observe contents of
delivery syringe to ensure that Contour Embolization Particles are well distributed
and suspended.
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