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

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CLINICALLY PROVEN RESULTS

• Proven effective – in clinical testing with

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

RADIESSE™ Voice and RADIESSE™ Voice Gel are injectable implants FDA-cleared for the treatment of vocal

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�

CONVENIENT AND EASY-TO-USE

• No preparation or mixing – supplied ready-to-

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�

• No evidence of implant migration�1,2,3

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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�

TWO FORMULATIONS FOR EVERY CONTINGENCY

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

UNIQUE MECHANISM OF ACTION

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 16 weeks 32 weeks 52 weeks 78 weeks

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FIGURE 1

Needle not correctly attached

Rotate to visualize green dot

FIGURE 2

Needle correctly attached

OPERATING ROOM TRANS-ORAL INJECTION

• 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

• 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

See “Instructions for Use” for complete information�

Note: RADIESSE Voice has a lower injection force if warmed and therefore may flow easier through the transoral needle�

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Trans-thyroid cartilage

Trans-cricothyroid

membrane

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

See “Instructions for Use” for complete information�

PERCUTANEOUS NEEDLE

1�5”, 25-gauge

PERCUTANEOUS NEEDLE TIP

Non-coring Huber point

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55See “Instructions for Use” for complete information�

IN-OFFICE THYROID INJECTION

• Transnasal endoscopic guidance

• Local anesthesia

• Notice start and end volume to determine volume injected

Needle inserted at injection site

Needle visible in airway via

transnasal endo-scope

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FIGURE 1

Needle not correctly attached

Rotate to visualize green dot

FIGURE 2

Needle correctly attached

TRANSORAL NEEDLE TIP

24-gauge, 1 cm tip

Marker at 5mm

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

See “Instructions for Use” for complete information�

TRAN-ORAL NEEDLE

25 cm long overall

16-gauge malleable shaft

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PEER-REVIEWED JOURNAL ARTICLES

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

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COMPOSITIONBy 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�

PACKAGINGRADIESSE™ 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�

STORAGEStore 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

See “Instructions for Use” for complete information�

Transoral needle tip

Percutaneous needle tip

• Percutaneous needle (9001M1): 25-gauge, 1�5 in long with non-coring Huber point

Transoral needle

Percutaneous needle

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MERZ AESTHETICS, INC.

1875 South Grant Street, Suite 200, San Mateo, CA 94402 | Phone: 650-286-4000

CUSTOMER SERVICE USA4133 Courtney Road, Suite 10, Franksville, WI 53126

Phone: 866-862-1209 | Fax: 866-862-1212 | Email: voice@merzaesthetics�com

CUSTOMER SERVICE EUROPE

Eckenheimer Landstraße 100, 60318 Frankfurt, GermanyPhone: +49 (0) 69-1503-8952 | Fax: +49 (0) 69-1503-743 | Email: voice@merz�de

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