Medtronic OSL271 Instructions for Use

OptiSphere™ Embolization Spheres

Instructions For Use

OptiSphere™

English / Instructions For Use..................1

Vascular Solutions, Inc.
6464 Sycamore Court North
Minneapolis, MN 55369 USA

USA CAUTION
Federal law restricts this device to sale by or on
the order of a physician.

DEVICE DESCRIPTION

OptiSphere embolization spheres consist of

biodegradable gelatin spheres pre-lled and

provided in a sterile, 20mL syringe. OptiSphere
is provided as either 1mL or 2mL of spheres
suspended in saline, at a total suspension volume
of approximately 6mL.

In an animal model, sphere degradation was
observed starting at 4 weeks; by 12 weeks, most
spheres were fully resorbed. The majority of treated
vessels showed no signs of recanalization at 12
weeks for both OptiSphere embolization spheres
and the comparative, commercially-available, non-

degradable, control product, based on uoroscopic

and histologic examinations in an animal model
OptiSphere embolization spheres are not

radiopaque. Monitor the procedure under

uoroscopy by adding the appropriate amount of

contrast to aid in the suspension and delivery of the
spheres.

[phone] USA
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www.vasc.com

Manufactured For:

Medtronic Sofamor Danek USA, Inc.
1800 Pyramid Place
Memphis, TN 38132
[phone] USA
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©2018 Vascular Solutions, Inc. 1 102338 Rev B 01/18

OptiSphere embolization spheres are manufactured
using an emulsion system and crosslinked with
glutaraldehyde.

The OptiSphere embolization spheres have been
sterilized using Gamma irradiation.

SPECIFICATIONS

OptiSphere embolization spheres are available

in four sizes, differentiated by a specic label and

syringe plunger color, as indicated in the chart
below:

Sphere Size

100-300μm Yellow OSL113 OSL213 0.020”

300-500μm Blue OSL135 OSL235 0.020”

500-700μm Red OSL157 OSL257 0.023”

600-800μm Silver OSL168 OSL268 0.027”

700-1000μm Green OSL171 OSL271 0.038”

INDICATIONS

OptiSphere embolization spheres are intended for
use in embolization of hypervascular tumors.

CONTRAINDICATIONS

• Patients with a known hypersensitivity to
porcine products

• Coronary and intracerebral vascular use

• In the pulmonary vasculature

• Patients intolerant to vascular occlusion
procedures

• Vascular anatomy or blood ow precluding
correct catheter placement or embolic injection

Label
Color

Model

Number,

1mL Fill

Model

Number,

2mL Fill

Minimum

Catheter

• Presence or suspicion of vasospasm

• Presence or likely onset of hemorrhage

• Presence of severe atheromatous disease

• Feeding arteries too small to accept the
selected device

• Presence of collateral vessel pathways
potentially endangering normal territories
during embolization

• High ow arteriovenous shunts or stula with
luminal diameter greater than the selected
size of the device

• Vascular resistance peripheral to the feeding
arteries precluding passage of the device into
the lesion

WARNINGS

The OptiSphere embolization spheres are provided
sterile for single use only. Reuse of a single­use device creates a potential risk of patient
or user infections and may compromise device
functionality, which may lead to illness or serious
patient injury.

OptiSphere embolization spheres should not be
used in the presence of infection. Gelatin-based
materials may serve as a nidus for infection and
abscess formation and have been reported to
potentiate bacterial growth.

PRECAUTIONS

Do not use the OptiSphere embolization spheres if
the packaging is damaged. A damaged package
could indicate a breach of sterility or device
damage.

Inspect the device for damage prior to use. Use of
a damaged device could result in injury.

Prior to delivering OptiSphere embolization

spheres, conrm that the selected delivery catheter

(not included) meets the minimum required inner
diameter for the selected sphere size. Use of a
delivery catheter that does not meet the minimum
inner diameter requirements may prevent delivery
or result in injury.

Prior to delivering OptiSphere embolization

spheres, conrm that the catheter is in the desired
location. Failure to conrm appropriate catheter

placement may result in non-target embolization.
OptiSphere embolization spheres are available in a

range of sizes and care should be taken to choose
the appropriate size for the site intended to be
treated. Improper size selection may result in injury.

I.D.

If the delivery catheter becomes obstructed or

signicant resistance is encountered during
injection, do not attempt to ush the catheter with

excessive pressure as non-target embolization may
occur.

ADVERSE EFFECTS

Potential adverse effects that may be associated
with the OptiSphere embolization spheres include,
but are not limited to, the following:

• Abscess

• Allergic reaction/anaphylaxis

• Capillary bed occlusion and tissue damage/
necrosis

• Fluid encapsulation

• Foreign body reactions

• Hematoma

• Hemorrhage

• Infection

• Inammation

• Ischemia at undesirable location

• Non-target embolization

• Pain

• Post-embolization syndrome

• Pulmonary embolism

• Seroma

• Transient hypertension

• Vasospasm

• Vessel or lesion rupture

CLINICAL PROCEDURE

The OptiSphere embolization spheres should be
used by physicians trained on the procedures for
which the device is intended. The techniques
and procedures described do not represent
ALL medically acceptable protocols, nor are
they intended as a substitute for the physician's

experience and judgment in treating any specic

patient. All available data, including the patient’s
signs and symptoms and other diagnostic test
results, should be considered before determining a

specic treatment plan.

Package contains:

• One (1) 20mL pre-lled syringe, packaged in a
peel-away tray. Each syringe contains one of
the following:

• Approximately 1 mL of OptiSphere

embolization spheres suspended in 5 mL
of sterile saline for injection

• Approximately 2 mL of OptiSphere

embolization spheres suspended in 4 mL
of sterile saline for injection

Other items required but not provided:

• Delivery catheter system with a minimum inner

diameter as specied in the above table.

• 1mL injection syringe

• Luer-lock 3-way stopcock

• Contrast media

PREPARATIONS FOR USE

Prior to use, carefully inspect the OptiSphere
embolization spheres packaging and components
for damage.

Utilizing sterile technique, remove the OptiSphere
embolization spheres from its packaging and

transfer to the sterile eld.

DEPLOYMENT PROCEDURE

Deploy the OptiSphere embolization spheres
according to the following steps:

1. Introduce the delivery catheter into the target
vessel according to standard techniques.
Position the catheter tip as close as possible
to the treatment site to avoid inadvertent
occlusion of normal vessels.

2. Attach a luer-lock 3-way stopcock to back end
or hub of the delivery catheter. Attach a 1mL
injection syringe to a female end of 3-way
stopcock. Flush system and ensure that air is
purged.

Note: Agitate syringe prior to use if
aggregates of spheres are clearly visible.

3. Remove any surplus air from the OptiSphere
syringe. Match the total volume in the pre-

lled syringe with an approximately equivalent

volume of undiluted contrast, which will result
in a 50% contrast 50% saline/sphere solution.

4. Gently invert the syringe several times until
the beads are evenly suspended in the
solution.

5. Attach the 20mL OptiSphere syringe to the
remaining port of the luer-lock 3-way stopcock.

6. Ensure the stopcock port connected to the
delivery catheter is closed and then draw the
solution into the 1mL injection syringe slowly

to minimize the potential of air introduction.

Note: Ensure all air is purged from system
prior to injection.

7. Inject the solution in the 1mL injection syringe

under uoroscopy using a slow, pulsatile

injection method while observing the contrast

ow rate.

8. If there is no effect on the contrast ow
rate, repeat delivery process with additional
injections of the solution.

9. Upon completion of the embolization
procedure, remove the delivery catheter while
maintaining gentle suction so that OptiSphere
embolization spheres remaining within the
catheter lumen are not dislodged.

10. Dispose of the product following standard
hospital procedures

STORAGE & HANDLING

No special storage or handling conditions.

LIMITED WARRANTY

Vascular Solutions, Inc. warrants that the
OptiSphere embolization spheres is free from
defects in workmanship and materials prior to the
stated expiration date. Liability under this warranty
is limited to refund or replacement of any product,
which has been found by Vascular Solutions, Inc. to
be defective in workmanship or materials. Vascular
Solutions, Inc. shall not be liable for any incidental,
special or consequential damages arising from
the use of the OptiSphere embolization spheres.
Damage to the product through misuse, alteration,
improper storage or improper handling shall void
this limited warranty.

No employee, agent or distributor of Vascular
Solutions, Inc. has any authority to alter or amend
this limited warranty in any respect. Any purported
alteration or amendment shall not be enforceable
against Vascular Solutions, Inc.

THIS WARRANTY IS EXPRESSLY IN LIEU
OF ALL OTHER WARRANTIES, EXPRESSED
OR IMPLIED, INCLUDING ANY WARRANTY
OF MERCHANTABILITY OR FITNESS FOR
A PARTICULAR PURPOSE OR ANY OTHER
OBLIGATION OF VASCULAR SOLUTIONS, INC.

PATENTS AND TRADEMARKS

May be covered by one or more U.S. or
international patents.

See: www.vasc.com/products/patents
OptiSphere is a trademark of Medtronic.

©2018 Vascular Solutions, Inc. 2 102338 Rev B 01/18