INJECTION VOCAL FOLD AUGMENTATION

INJECTION VOCAL FOLD AUGMENTATION
TABLE OF CONTENTS
RADIESSE™ Voice and RADIESSE™ Voice Gel ����������������������������������������������������������1
Vocal Fold Augmentation Technique ��������������������������������������������������������������������������3
RADIESSE™ Voice and RADIESSE™ Voice Gel Reference Materials ��������������������������7
Technical Data and Ordering Information �������������������������������������������������������������������8
paralysis, hoarseness, bowing, and other glottal incompetence.
RADIESSE™ Voice is CE-marked. RADIESSE™ Voice Gel is currently not available in Europe.
RADIESSE™ Voice is convenient, easy-to-use, and safe. Unlike some other implants, RADIESSE™ Voice does not
migrate or cause granuloma formation. It stays in place, providing long-lasting correction.
CLINICALLY PROVEN RESULTS
CONVENIENT AND EASY-TO-USE
• Proven effective – in clinical testing with
• No preparation or mixing – supplied ready-to-
12-month follow-up, the majority of patients
treated with RADIESSE™ Voice reported their
voice was greatly or significantly improved.2
• Proven safe – no long-lasting granuloma
formation or major complications have been
reported.2
• Proven long-lasting – results with RADIESSE™
Voice typically last more than 12 months.2
• Results with RADIESSE™ Voice Gel have been
shown to last up to 3 months.7
use in a 1.0 cc syringe with injection needle.
• No refrigeration – store at room temperature.
• No allergy testing – contains no animal or human
components.
• No waiting – injection can be performed in-office
in 30 minutes or less.
CONSISTENT, PREDICTABLE,
STABLE CORRECTION
• Made from synthetic materials with extensive
history of biocompatibility.
• Consistent, predictable correction.
RADIESSE™ Voice and RADIESSE™ Voice Gel
RADIESSE™ Voice and RADIESSE™ Voice Gel are injectable implants FDA-cleared for the treatment of vocal
• No evidence of implant migration.1,2,3
1
RADIESSE™ Voice and RADIESSE™ Voice Gel
TWO FORMULATIONS FOR EVERY CONTINGENCY
RADIESSE™ Voice is an injectable implant containing synthetic Calcium
Hydroxylapatite (CaHA) microspheres, which have a diameter range of 25
µm to 45 µm suspended in an aqueous gel carrier and is injectable through
a 25-gauge needle. RADIESSE™ Voice provides long lasting vocal fold
augmentation and has been shown to be effective up to 12 months.2
RADIESSE™ Voice Gel is an injectable implant containing synthetically
derived polymers, and no CaHA microspheres, suitable for short term vocal
fold augmentation, in patients where reversible nerve damage is suspected,
or in patients wishing a short term augmentation before making a decision to
have a long term augmentation done with RADIESSE™ Voice.
UNIQUE MECHANISM OF ACTION
Over time the carrier gel in RADIESSE™ Voice is resorbed and the CaHA particles support in-growth of new
collagen. The durable CaHA microspheres degrade slowly over years for a long-lasting effect.8
In both clinical testing and clinical use, no implant migration or evidence of long-term granuloma formation have
been observed.1,2,3
RADIESSE™ Voice (CaHA+Gel) initially
performs as bulking agent.
Macrophages start to degrade gel
carrier (2-3 Months).
Macrophages dissolve gel carrier as new collagen
forms. Collagen growth provides for a long term
augmentation that may last for a year or more in
many patients.
Ultimately, CaHA particles start to degrade and
are metabolized by macrophages.
Histology studies demonstrate deposition of new collagen around CaHA microspheres over an extended time
course. Collagen fibers stain red, while other tissue elements appear more yellow.8
4 weeks
2
16 weeks
32 weeks
52 weeks
78 weeks
• Direct laryngoscopy or micro-laryngoscopy
• Similar to autologeous fat injections but less over correction required (10-15%)
OPTIMAL INJECTION LOCATION AND VOLUME
• Vocal fold injections should be at the level of the vocal process
• Depth of the vocal fold injection should be approximately 5-7 millimeters
• No pre-set vocal fold injections volume. The vocal fold injection volume
should be done strictly on immediate clinical observation and
approximately 10-15% over correction is recommended
FIGURE 1
Needle not correctly attached
Rotate to visualize green dot
FIGURE 2
Vocal Fold Augmentation Technique
OPERATING ROOM TRANS-ORAL INJECTION
Needle correctly attached
• Connect needle (notice alignment of green dot) See Figures 1 and 2
• Needle is delivered straight–bend to fit patient anatomy and physician preference
• Prime needle (~0.18 cc dead volume)
• Notice start and end volume to determine volume injected
TRANSORAL NEEDLE
25 cm long overall
16-gauge malleable shaft
TRANSORAL NEEDLE TIP
24-gauge, 1 cm tip
Marker at 5mm
Note: RADIESSE Voice has a lower injection force if warmed and therefore may flow easier through the transoral needle.
See “Instructions for Use” for complete information.
3
Vocal Fold Augmentation Technique
IN-OFFICE PERCUTANEOUS INJECTION
• Transnasal endoscopic guidance
• Local anesthesia
• Needle has non-coring “Huber” tip
• Prime needle
• Notice start and end volume to determine volume injected
PERCUTANEOUS NEEDLE
1.5”, 25-gauge
PERCUTANEOUS NEEDLE TIP
Non-coring Huber point
Trans-thyroid cartilage
Trans-cricothyroid
membrane
4
See “Instructions for Use” for complete information.
Vocal Fold Augmentation Technique
IN-OFFICE THYROID INJECTION
• Transnasal endoscopic guidance
• Local anesthesia
• Notice start and end volume to determine volume injected
Needle visible in airway via
transnasal endo-scope
Needle inserted at injection site
See “Instructions for Use” for complete information.
5
Vocal Fold Augmentation Technique
IN-OFFICE TRANS-ORAL INJECTION
• Topical anesthesia (drip onto larynx)
• Connect needle (notice alignment of green dot) See Figures 1 and 2
• Needle is delivered straight–bend to fit patient anatomy and physician preference
• Prime needle (~0.18 cc dead volume)
• Notice start and end volume to determine volume injected
TRAN-ORAL NEEDLE
25 cm long overall
16-gauge malleable shaft
TRANSORAL NEEDLE TIP
24-gauge, 1 cm tip
Marker at 5mm
FIGURE 1
Needle not correctly attached
Rotate to visualize green dot
FIGURE 2
Needle correctly attached
6
See “Instructions for Use” for complete information.
1. Gillespie, Boyd M., et al, Effectiveness of Calcium Hydroxylapatite (RADIESSE™ Voice) in Voice
Rehabilitation, Annals of Otology, Rhinology & Laryngology (2009), 118(8):546-551
2. Rosen, Clark A., et al, Vocal Fold Augmentation with Calcium Hydroxylapatite (RADIESSE™ Voice):
Twelve Month Report, Laryngoscope (2009), 119(5):1033-41
3. Rees, Catherine J., et al, Thyrohyoid Vocal Fold Augmentation with Calcium Hydroxylapatite
(RADIESSE™ Voice), Otolaryngology – Head and Neck Surgery (June 2008), 138(6):743-746
4. Rosen, Clark A., et al, Vocal Fold Augmentation with Calcium Hydroxylapatite (RADIESSE™ Voice),
Otolaryngology – Head and Neck Surgery (February 2007), 136(2):198-204
5. Amin, Milan R., Thurohyoid Approach for Vocal Fold Augmentation, Annals of Otology, Rhinology &
Laryngology (2006), 115(9):699-702
6. Hughes, Richard G.M., et al, Vocal Cord Medialization by Transcutaneous Injection of Calcium
Hydroxylapatite (RADIESSE™ Voice), Journal of Voice (December 2005), 19(4):674-678
7. Kwon, Tack-Kyun, et al, Preliminary Results of a New Temporary Vocal Fold Injection Material
(RADIESSE™ Voice Gel), Journal of Voice (December 2005), 19(4):668-673
8. Marmur, E.S., et al, Clinical, Histological and Electron Microscopic Findings After Injection of a Calcium
Hydroxylapatite Filler, Journal of Cosmetic Laser Therapy (December 2004), 6(4):223-226
9. Belafsky, Peter C., et al Vocal Fold Augmentation with Calcium Hydroxylapatite (RADIESSE™ Voice),
Otolaryngology – Head and Neck Surgery (October 2004), 131(4):351-354
10.Rosen, Clark A., Vocal Fold Augmentation with Injectable Calcium Hydroxylapatite (RADIESSE™
Voice), Journal of Voice (September 2004), 18(3):387-391
11.Chhetri, Dinesh K., et al, Injection Laryngoplasty with Calcium Hydroxylapatite Gel Implant
(RADIESSE™ Voice) in an In-Vivo Canine Model, Annals of Otology, Rhinology & Laryngology (April
2004), 113(4):259-264
RADIESSE™ Voice and RADIESSE™ Voice Gel Reference Materials
PEER-REVIEWED JOURNAL ARTICLES
7
Technical Data and Ordering Information
COMPOSITION
By volume RADIESSE™ Voice is approximately 30% Calcium Hydroxylapatite (CaHA) and
70% carrier gel. The carrier gel contains glycerin, Sodium Carboxymethylcellulose, and sterile water. RADIESSE™
Voice Gel contains the same carrier gel without CaHA microspheres.
PACKAGING
RADIESSE™ Voice and RADIESSE™ Voice Gel are pre-filled in a latex-free polycarbonate syringe in a volume of
1.0 cc.
The syringe is packed in a foil pouch enclosed in a product box.
STORAGE
Store at ambient temperature of 15-32°C (59-90°F).
CATALOG NUMBER
• RADIESSE™ Voice:
PN 8044M0 (USA)
8044M2 (Europe)
• RADIESSE™ Voice Gel: PN 8602M0 (USA)
Not currently available in Europe
INJECTION NEEDLES
• Transoral injection needle (9010M1):
25 cm long, 16-gauge malleable needle shaft
1 cm needle tip (24-gauge) with marker at 5 mm
Transoral needle
• Percutaneous needle (9001M1):
25-gauge, 1.5 in long with non-coring Huber point
Percutaneous needle
8
See “Instructions for Use” for complete information.
Transoral needle tip
Percutaneous needle tip
MERZ AESTHETICS, INC.
1875 South Grant Street, Suite 200, San Mateo, CA 94402
|
Phone: 650-286-4000
CUSTOMER SERVICE USA
4133 Courtney Road, Suite 10, Franksville, WI 53126
Phone: 866-862-1209
|
Fax: 866-862-1212 | Email: [email protected]
CUSTOMER SERVICE EUROPE
Eckenheimer Landstraße 100, 60318 Frankfurt, Germany
Phone: +49 (0) 69-1503-8952 | Fax: +49 (0) 69-1503-743
|
Email: [email protected]
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www.radiesse-voice.com
Copyright © 2011 Merz Aesthetics, Inc. All rights reserved. RADIESSE is a trademark of Merz Aesthetics, Inc. The Merz logo is a registered trademark of Merz Pharma
GmbH & Co. KGaA. ML00157-03