Radiesse (+) Lidocaine

Radiesse (+) Lidocaine is a sterile, latex-free, non-pyrogenic, semi-solid cohesive injectable implant manufactured by Merz Aesthetics, developed for deep dermal and sub-dermal soft tissue augmentation. It suits supraperiosteal, sub-dermal and deep dermal placement with a 27G needle, and deep blunt-tip cannula injection for the jawline. It is 30% synthetic CaHA particles (25 to 45 microns) in a 70% gel carrier with 0.3% lidocaine hydrochloride; the carrier dissipates in vivo while the CaHA remains, for long-term but non-permanent augmentation. One 1.5 mL pre-filled syringe and two 27G thin-wall needles come sterile in a sealed foil pouch, for single treatment use.

• Synthetic calcium hydroxylapatite implant with 0.3% lidocaine hydrochloride included for a short-term local anaesthetic effect during injection
• 30% CaHA particles and 70% gel carrier by volume, 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
• Indicated for the jawline and marionette lines in addition to nasolabial folds, cheeks and the dorsum of the hands
• A lifetime of at least 12 months for cheek augmentation, the jawline and hand augmentation, as demonstrated minimums rather than expected end points
• Well suited to supraperiosteal, sub-dermal and deep dermal placement; jawline placement by blunt-tip cannula has been clinically evaluated
• 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

Показания и профессиональное применение

Основные показания

• Treatment of nasolabial folds
• Augmentation of the cheeks
• Treatment of marionette lines
• Treatment of the jawline
• Hand augmentation to correct volume loss in the dorsum of the hands

Профессиональное применение

Radiesse (+) Lidocaine 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. Because this presentation contains 0.3% lidocaine hydrochloride, practitioners must screen for known hypersensitivity to lidocaine or to anaesthetics of the amide type before use. 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, 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.

Зоны применения

• Nasolabial folds
• Cheeks
• Marionette lines
• Jawline
• Dorsum of the hands
• Not intended for the glabellar folds or the nose area, where a higher incidence of localised necrosis has been associated with injection

Профиль пациента

Suitable for adult patients assessed as appropriate by the treating practitioner. Radiesse (+) Lidocaine 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 with known hypersensitivity to lidocaine or to anaesthetics of the amide type; in persons prone to developing inflammatory skin conditions or with a tendency to develop hypertrophic scars and keloids; in persons with bleeding disorders; in persons under 18 years; 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 two years in the hand has not been investigated in clinical trials.

Как работает Radiesse (+) Lidocaine ​

Почему стоит заказывать в Allpara

Allpara предлагает оригинальные проверенные продукты RADIESSE от проверенных поставщиков, с полной прослеживаемостью партий и экспертной поддержкой. Мы обслуживаем клиники и специалистов эстетической медицины: продукты с сертификатом CE, быстрая доставка по ЕС с нашего склада в ЕС и конкурентные оптовые цены. Наш приоритет - безопасность, удовлетворённость и результаты ваших пациентов, а также внимательная послепродажная поддержка для вашего спокойствия.

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