Radiesse

Radiesse is a sterile, latex-free, non-pyrogenic, semi-solid cohesive injectable implant manufactured by Merz Aesthetics, designed for deep dermal and sub-dermal soft tissue augmentation with a 27G needle. Its gel carrier dissipates in vivo, replaced by soft tissue growth, while the calcium hydroxylapatite stays in place, for long-term but non-permanent restoration and augmentation. By weight it is 56% synthetic CaHA particles (25 to 45 microns) and 44% carrier of sterile water for injection, glycerin and sodium carboxymethylcellulose. One pre-filled 1.5 mL syringe and two 27G thin-wall needles come sterile in a sealed foil pouch, for single person, single treatment use.

• Synthetic calcium hydroxylapatite implant, a different product class from a hyaluronic acid filler
• 56% CaHA particles and 44% gel carrier by weight, with a particle size of 25 to 45 microns
• The gel carrier is dissipated in vivo and replaced with soft tissue growth, while the CaHA remains at the injection site
• A lifetime of at least 12 months across every approved indication, as a demonstrated minimum rather than an expected end point
• Highly viscoelastic, well suited to sub-dermal and deep dermal placement for a considerable volumising effect
• Can be diluted 1:2 with sterile saline for larger areas such as the décolleté
• Supplied sterile in a sealed foil pouch as one 1.5 mL syringe with two 27G thin-wall needles
• CE marked under EU MDR 2017/745 via notified body 0123, supplied with a patient Implant Card
• Manufactured by Merz Aesthetics in the USA

Indicações e utilização profissional

Principais indicações

• Treatment of nasolabial folds
• Augmentation of the cheeks
• Hand augmentation to correct volume loss in the dorsum of the hands
• Restoration and correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus
• Moderate and severe décolleté wrinkles, when diluted 1:2 with 0.9% sterile saline

Utilização profissional

Radiesse is only to be administered by appropriately trained healthcare professionals who are qualified or accredited in accordance with national law. The product is supplied sterile and non-pyrogenic in a sealed foil pouch and is intended for single-person, single-treatment use only, for deep dermal and sub-dermal soft tissue augmentation. Injection technique, plane and volume are determined by the treating practitioner on a per-patient basis. Introduction of the implant into the vasculature may lead to embolisation or thrombosis, occlusion of the vessels, ischaemia or infarction, so particular care is required when injecting soft tissue fillers. The product must not be re-sterilised, and must not be used if the foil pouch is compromised or the syringe damaged.

Zonas de tratamento

• Nasolabial folds
• Cheeks
• Dorsum of the hands
• Areas of facial fat loss (lipoatrophy) in people with HIV
• Décolleté, when diluted 1:2 with 0.9% sterile saline
• Not intended for the glabellar folds or the nose area, where a higher incidence of localised necrosis has been associated with injection

Perfil do paciente

Suitable for adult patients assessed as appropriate by the treating practitioner. Radiesse is contraindicated in the presence of acute or chronic inflammation or infection involving the area to be treated; in persons with severe allergies manifested by a history of anaphylaxis, or a history or presence of multiple severe allergies; in persons with known hypersensitivity to any of the components; in persons prone to developing inflammatory skin conditions or with a tendency to develop hypertrophic scars and keloids; in persons with bleeding disorders; and during pregnancy and in breastfeeding females. It must not be implanted in the epidermis or used as a skin replacement, and is not intended for correction of the glabellar folds or the nose area. For hand augmentation, the safety of injection into the dorsum of the hand has not been studied in persons under 26 or over 79 years of age, volumes over 3 mL per hand in a treatment session have not been studied, and safety beyond one year in the hand has not been investigated in clinical trials.

Como funciona Radiesse ​

Porquê encomendar na Allpara

A Allpara oferece produtos RADIESSE originais e verificados de fornecedores selecionados, com rastreabilidade total dos lotes e apoio especializado. Servimos clínicas e profissionais de estética com produtos com certificação CE, entrega rápida em toda a UE a partir do nosso armazém na UE e preços profissionais competitivos. A nossa prioridade é a segurança, a satisfação e os resultados dos seus pacientes, com apoio pós-venda dedicado para a sua tranquilidade.

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