INDICATION:RADIESSE® and RADIESSE® (+) Injectable Implants are FDA-approved for subdermal implantation for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds. RADIESSE® is also indicated for hand augmentation to correct volume loss in the dorsum of the hands.

Please see additional Important Safety Information inside and on back page.

Designed to better support how you use RADIESSE® in your practice.

RADIESSE and RADIESSE (+) twin packs are available in the 1.5cc syringe size

Each box contains 2 syringes sealed in individual pouches

Slim-line box design that requires less storage space

Eco-friendly packaging that uses less paper and reduces waste

INTRODUCING THE NEW RADIESSE® AND RADIESSE® (+) TWIN PACKS: 2 SYRINGES IN 1 BOX EQUALS TOTAL TREATMENT CONVENIENCE

NEW RADIESSE® PACKAGING DESIGNED WITH YOU AND YOUR PATIENTS IN MIND

LIFT, CONTOUR, AND REJUVENATE FOR A MORE YOUTHFUL, NATURAL LOOK3-5

A highly elastic, viscous filler for immediate, effective lift that stays in place6,7

Whether it’s face or hands, many RADIESSE treatments may require more than one syringe. Which is why we have developed the new RADIESSE twin pack.

Viscosity and elasticity help predict a filler’s ability to enhance volume and achieve lift for a more youthful appearance. These characteristics influence both how the filler spreads into the skin during injection as well as the filler’s ability to withstand the skin’s forces during facial movement.6,7

Less RADIESSE may be required for full correction, giving your practice and your patients more value with each syringe. Moreover, most other fillers are packaged with 1 cc (1 mL) of filler per syringe. So with RADIESSE, you get more filler to work with from the start. And because now each twin pack includes 3 cc of RADIESSE, each box of RADIESSE may go even further during treatment.

† Multicenter, controlled, blinded, randomized, multiarm, 16-month study of 205 patients with moderate-to-severe nasolabial folds comparing RADIESSE to JUVÉDERM® Ultra Injectable Gel and Perlane® Injectable Gel. Physicians injected enough material to achieve optimal correction. A total of 189 patients received touch-up treatment at 4 months. Total treatment volume shown (initial plus touch-up volume).2 

TOTAL MEAN TREATMENT VOLUME (CC)1,†

RADIESSE® JUVÉDERM® Ultra Perlane®

3.5

3

2.5

2

1.5

1

0.5

0

Majority of today’s patients use 2 syringes per treatment

Warnings (continued):Do not overcorrect (overfill) a contour deficiency with these products.

The safety and effectiveness of RADIESSE or RADIESSE (+) in the following situations has not been established:

• Use in the lips. There have been published reports of nodules associated with the use of these products in the lips.

• In patients with very severe loss of fatty tissue with marked visibility of veins and tendons.

• Injection volumes over 3 cc of RADIESSE® per hand in a treatment session

Avoid injection into veins or tendons in the hand, as this may weaken tendons and cause tendon rupture or cause embolization or thrombosis.

Injection into the dorsum of the hand may cause adverse events that last for more than 14 days, and may result in temporary difficulty performing activities (48% of study patients reported this adverse event). Fitzpatrick Skin Types IV-VI may have an increased risk (68% of Fitzpatrick Skin Types IV-VI reported this event). RADIESSE® may cause nodules, bumps or lumps in the dorsum of the hand (12% reported this event) and can last up to 1 year.

Increased bruising is associated with higher volume injection. Retreatment with RADIESSE® of volumes greater than approximately 1.6cc per hand in a treatment session can result in increased adverse events (redness, pain, swelling, and difficulty performing activities).Please see additional Important Safety Information on back page.

The filler that goes further

*Individual results may vary. Unretouched photos of actual patient.

Before

After* After*Before

Treatment volume: 1 syringe (1.5 cc) per hand.* Individual results may vary. Unretouched photos of actual patients. Treatment volume for the lower face: 3 syringes (4.5 cc). Treatment volume per hand: 1 syringe (1.5 cc).

Provides outstanding lift capacity and stays where you place it

Ideal for restoring a youthful appearance to the lower face

A high viscosity filler8:

• Remains where it is injected with less migrating.• Maintains a more solid form than a filler with a

low viscosity.

** Based on in vitro study. Data shown does not imply clinical effect or clinical difference between products.

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200,000

150,000

350,000

100,000

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RADIESSE® DEMONSTRATED HIGHER VISCOSITY COMPARED TO HA-BASED FILLERS**

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RADIESSE® DEMONSTRATED HIGHER ELASTICITY COMPARED TO HA-BASED FILLERS**

A higher elasticity filler8:

• Withstands deformation while it is being injected.• Resists on-going forces from facial movements

and gravity.• Promotes volumization and lifting of areas that

experience high levels of muscle activity.

LeAnne / 47

RADIESSE® and RADIESSE® (+) IMPORTANT SAFETY INFORMATION:

Contraindications: These products are contraindicated for patients with severe allergies manifested by a history of anaphylaxis, or history or presence of multiple severe allergies; patients with known hypersensitivity to any of the components; and patients with bleeding disorders. RADIESSE® (+) is contraindicated in patients with known hypersensitivity to lidocaine or anesthetics of the amide type.

Warnings: Introduction of product into the vasculature may lead to embolization, occlusion of the vessels, ischemia, or infarction. Take extra care when injecting soft tissue fillers, for example inject the product slowly and apply the least amount of pressure necessary. Rare but serious adverse events associated with the intravascular injection of soft tissue fillers in the face have been reported and include temporary or permanent vision impairment, blindness, cerebral ischemia or cerebral hemorrhage, leading to stroke, skin necrosis, and damage to underlying facial structures. Immediately stop the injection if a patient exhibits any of the following symptoms, including changes in vision, signs of a stroke, blanching of the skin, or unusual pain during or shortly after the procedure. Patients should receive prompt medical attention and possibly evaluation by an appropriate health care practitioner specialist should an intravascular injection occur.

Use of these products in any person with active skin inflammation or infection in or near the treatment should be deferred until the inflammatory or infectious process is controlled.

Please see additional Important Safety Information on next page.

A NEW ADDITION TO YOUR PRACTICE

New and improved RADIESSE® twin pack offers value and convenience

• Two syringes sealed in individual pouches• Slim-line box design that requires less storage space• Eco-friendly packaging that uses less paper and reduces waste

Robust lifting capacity for a more youthful, natural-looking appearance2,5:

• Less volume required to achieve full correction with RADIESSE® versus other dermal fillers, as shown in two separate clinical studies6,7

• High level of elasticity for immediate and effective lift6,7

• High-viscosity gel remains where it is placed6,7

RADIESSE® and RADIESSE® (+) IMPORTANT SAFETY INFORMATION:Precautions: In order to minimize the risk of potential complications, this product should only be used by healthcare practitioners who have appropriate training, experience and who are knowledgeable about the anatomy at and around the injection site. Healthcare practitioners should fully familiarize themselves with the product, the product educational materials and the entire package insert.The safety and effectiveness of these products in the following situations has not been established:

• In patients with diseases, injuries, or disabilities of the hand• Beyond 3 years in the face and 1 year in the hand• In the periorbital area• Interactions between RADIESSE® or RADIESSE® (+) with drugs or

other substances or implants• Use during pregnancy, or in breastfeeding women• In the dorsum of the hand in patients under 26 years old and over

79 years old• In the face in patients under 18 years old• In patients with increased susceptibility to keloid formation and

hypertrophic scarring• With concomitant dermal therapies such as epilation, UV

irradiation, or laser, mechanical, or chemical peeling proceduresThese products contain calcium hydroxylapatite (CaHA) particles that are radiopaque and are clearly visible on CT Scans and may be visible in standard, plain radiography. As with all transcutaneous procedures, injection of these products carries a risk of infection. Care should be used in treating patients with autoimmune disease affecting the hand, hand implants, Dupuytren’s contracture, history of hand tumor, vascular malformations, Raynaud’s disease and patients at risk for tendon rupture.Use of RADIESSE® in the dorsum of the hand may result in significant swelling of the dorsum of the hand. Patients who are using medications that can prolong bleeding, such as aspirin or warfarin, may experience increased bruising or bleeding at the injection site. Patients with a history of previous herpetic eruption may experience reactivation of the herpes.

Patients should minimize strenuous activity and exposure of the treated area to extensive sun or heat exposure for approximately 24 hours after treatment or until any initial swelling and redness has resolved. Adverse Events: Common adverse events seen in clinical studies of RADIESSE® injected into the dorsum of the hand include bruising, redness, swelling, pain, itching, nodule or bumps/ lumps, difficulty performing activities, loss of sensation, and other local side effects. Common adverse events seen in clinical studies of RADIESSE® or RADIESSE® (+) injected into the face include bruising, redness, swelling, pain, itching, and other local side effects. Information on adverse events from post-market surveillance of RADIESSE® and RADIESSE® (+) are included in the Instructions for Use (IFU) and Patient Information Guide (PIG) based on an assessment of seriousness and potential causal relationship to RADIESSE® or RADIESSE® (+). Please see the IFU and PIG available at www.radiesse.com for a complete list of these events. To report a problem with RADIESSE® or RADIESSE® (+), please call MyMerz Solutions at 1-844-469-6379. For complete Safety Information please refer to the IFU at Radiesse.com.Rx onlyReferences: 1. RADIESSE [instructions for use]. Franksville, WI: Merz North America, Inc.; 2013. 2. Moers-Carpi M, Vogt S, Santos BM, Planas J, Vallve SR, Howell DJ. A multicenter, randomized trial comparing calcium hydroxylapatite to two hyaluronic acids for treatment of nasolabial folds. Dermatol Surg. 2007;33(suppl 2):S144-S151. 3. Marmur ES, Phelps R, Goldberg DJ. Clinical, histologic and electron microscopic findings after injection of a calcium hydroxylapatite filler. J Cosmet Laser Ther. 2004;6(4):223-226. 4. Coleman KM, Voigts R, DeVore DP, Termin P, Coleman WP 3rd. Neocollagenesis after injection of calcium hydroxylapatite composition in a canine model. Dermatol Surg. 2008;34(suppl 1):S53-S55. 5. Berlin AL, Hussain M, Goldberg DJ. Calcium hydroxylapatite filler for facial rejuvenation: a histologic and immunohistochemical analysis. Dermatol Surg. 2008;34(suppl 1):S64-S67. 6. Sundaram H, Voigts B, Beer K, Meland M. Comparison of the rheological properties of viscosity and elasticity in two categories of soft tissue fillers: calcium hydroxylapatite and hyaluronic acid. Dermatol Surg. 2010;36(suppl 3):1859-1865. 7. Sundaram H, Cassuto D. Biophysical characteristics of hyaluronic acid soft-tissue fillers and their relevance to aesthetic applications. Plast Reconstr Surg. 2013;132(4 suppl 2):5S-21S. Erratum in: Plast Reconstr Surg. 2013;132(5):1378. 8. Data on file.

Copyright © 2016 Merz North America, Inc. All rights reserved. MERZ AESTHETICS and the MERZ AESTHETICS logo are trademarks of Merz Pharma GmbH & Co. KGaA. RADIESSE and RADIESSE (+) are registered trademarks of Merz North America, Inc. JUVÉDERM® mark owned by Allergan Industrie, SAS. VOLUMA® is a registered trademark owned by Allergan, Inc. Perlane® and Restylane® are registered trademarks of Galderma Laboratories, L.P. Perlane is now US FDA-approved as Restylane® Lyft (with lidocaine).

To learn more about other Merz North America brands, please visit www.merzusa.com.ML01661-00

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