Concealable Prosthesis
AMS spectra™ Concealable
PENILE Prosthesis
The AMS Spectra prosthesis offers simplified sizing, ease of placement,
excellent concealment and rigidity.1
about the device1
s P
rovides a balance between rigidity and concealment
s S imple to implant and easy for patients to use
s U
nique spring and cable design
s P
rovides the ability to position with minimal spring back
s D
iameter: 9.5 mm, 12 mm and 14 mm
s M
ultiple configurations for a wide range of patient sizes
s Length: 12 cm, 16 cm or 20 cm
s E asy attachment of RTE to cylinder
s S nap-fit Rear Tip Extenders (RTEs): add length
to the proximal cylinder end of 0.5 to 7.5 cm
(excluding 7.0 cm) in 0.5 cm increments
s S nap-fit RTEs optimize fit and provide a secure, rigid connection
Important Safety Information2
s N
ot for patients with urogenital infections or active skin infections in region of surgery.
s W
ill make latent natural or spontaneous erections, as well as other interventional treatment options impossible.
s Penile shortening, curvature or scarring may result.
s P
atients with diabetes, spinal cord injuries, or open sores may have an increased risk of infection associated with a prosthesis.
Simple. Spontaneous.
AMS Spectra
™
Concealable
Penile Prosthesis
excellent Concealment
DIMENSIONAL SPECIFICATIONS
Cylinder x Cylinder Cylinder
Diameter
LengthProduct Number
7°
Spectra
Angle of
Concealment1
x
12 cm
720054-01
9.5 mm
x
16 cm
720054-02
9.5 mm x
20 cm
720054-03
12 mm
x
12 cm
720074-01
12 mm
x
16 cm
720074-02
12 mm x
20 cm 720074-03
14 mm x
12 cm 720056-01
14 mm x
16 cm 720056-02
14 mm x
20 cm 720056-03
Snap-fit RTEs are used with Spectra cylinders.
Simplified Sizing
6.0
5.0
4.0
3.0
2.0
1.5
1.0
0.5
AMS RTEs (cm)
9.5 mm 1.5 cm
stackable
Spectra™ cylinder length + Snap-fit RTE = Total intracorporal length
1 Data on file at AMS for Spectra Concealable Prosthesis
2 AMS Spectra™ Instructions for Use. American Medical Systems, Inc. 2009.
Cylinder
Diameter
RTE
RTE Product
Length(s)Number
9.5 mm
0.5, 1, 1.5, 2, 3 cm (kit)720170-01
9.5 mm 4, 5, 6 cm (kit) 720171-01
12 mm & 14 mm 0.5 cm 72404320 12 mm & 14 mm 1 cm 72404321 12 mm & 14 mm 2 cm 72404322 12 mm & 14 mm 3 cm 72404323 12 mm & 14 mm 4 cm 72404324 12 mm & 14 mm 5 cm 72404325 12 mm & 14 mm 6 cm 72404326 12 mm & 14 mm 1.5 cm stackable 72404330 The 1.5 cm RTE is the only RTE that can be used in combination
with another Snap-fit RTE.
Sizers (Non-sterile)
Product Number
9.5 mm and 12 mm diameters
720153-01
9.5 mm and 12 mm sizers are packaged together.
The AMS Spectra™ Concealable Penile Prosthesis is a sterile, non-pyrogenic, single-use implant that is intended for use in the treatment of chronic, organic, erectile dysfunction
(impotence) in men who are determined to be suitable candidates for implantation surgery. These devices are contraindicated in patients who: have active urogenital infections or
active skin infections in the region of surgery; patients whose proximal corporal length measurements is less than the proximal rigid section of the Spectra cylinders, or whose total
intracorporal length is not within the range of 12cm to 27.5cm; patients who require repeated endoscopic procedures; or patients who have compromised tissue and as a result
cannot withstand constant pressure. Implantation will make latent natural or spontaneous erections, as well as other interventional treatment options, impossible. Men with diabetes,
spinal cord injuries or open sores may have an increased risk of infection. Failure to evaluate and treat device erosion may result in infection and loss of tissue. Implantation may
result in penile shortening, curvature, or scarring. Possible adverse events include, but are not limited to: infection, erosion, migration, extrusion, mechanical malfunction, patient
dissatisfaction, adverse tissue reaction, allergic reaction, pain, urinary obstruction, and silicone particle migration. Prior to using these devices, please review the Instructions for Use
for a complete listing of indications, contraindications, warnings, precautions and potential adverse events.
Rx Only
Spectra™ is a trademark of American Medical Systems, Inc.
© 2013 American Medical Systems, Inc. All Rights Reserved. Minnetonka, MN 55343
AMSUS/SPEC-00154/June 2013 www.AmericanMedicalSystems.com 1-800-328-3881
AU, CA, NZ and US Use Only