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Primeiro paciente dos EUA inscrito em estudo de periféricos SELUTION SLR IDE
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MedAlliance

Aug 24, 2022, 09:00 ET

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GENEBRA, Suíça, 24 de agosto de 2022 /PRNewswire/ -- O primeiro paciente dos EUA foi inscrito no estudo clínico FDA SELUTION4BTK (abaixo do joelho), que avaliará o SELUTION SLR™, o novo balão eluidor de sirolimus da MedAlliance. Este marco sucede à aprovação da isenção de dispositivo de investigação (IDE) nos Estados Unidos em maio de 2022, com a inscrição do primeiro paciente sendo feita na Alemanha uma semana após a aprovação.  

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First US Patient Enrolled in SELUTION SLR IDE Peripheral Study (PRNewsfoto/MedAlliance)
First US Patient Enrolled in SELUTION SLR IDE Peripheral Study (PRNewsfoto/MedAlliance)

"Estamos muito animados por finalmente ter a tecnologia de eluição de drogas nos EUA para tratar essa população de pacientes desafiadores", comentou o investigador principal do estudo, o Dr. Ehrin Armstrong. "Os resultados iniciais positivos com este novo balão eluidor de sirolimus, o SELUTION SLR, na Europa e na Ásia, são animadores. Esperamos que este estudo IDE da FDA demonstre benefícios significativos para pacientes que atualmente têm opções limitadas de tratamento."

O objetivo do estudo clínico SELUTION4BTK é demonstrar a eficácia superior e a segurança equivalente do SELUTION SLR em comparação com a angioplastia com balão convencional (POBA) no tratamento das artérias abaixo do joelho em pacientes com Isquemia Crônica com Ameaça aos Membros Inferiores. O estudo clínico é um estudo prospectivo, multicêntrico, mono-cego e randomizado. (ClinicalTrials.gov Identifier: NCT05055297).

Estão sendo randomizados 377 indivíduos na razão de 1:1 entre SELUTION SLR e controle. Este é o primeiro estudo desse tipo em que pacientes com Isquemia Crônica com Ameaça aos Membros Inferiores podem ser incluídos. As inscrições estão abertas para pacientes em aproximadamente 40 centros nos Estados Unidos, Europa e Ásia. O primeiro paciente dos EUA foi inscrito em Vascular Solutions em Cary, na Carolina do Norte, pelo Dr. Siddhartha Rao.  

"Estamos muito satisfeitos por participar deste estudo inovador", disse o Dr. Rao, "Esperamos que esta tecnologia promissora atenda a uma enorme necessidade de nossos pacientes com isquemia crônica com ameaça aos membros, salvando tanto a vida quanto o membro. Esperamos que o período de inscrição neste estudo seja breve."

"Fomos a primeira empresa a receber a "designação de dispositivo inovador" para um balão eluidor de medicamentos pela FDA e temos orgulho de inscrever o primeiro paciente dos EUA em um estudo de balão eluidor de sirolimus", acrescentou Jeffrey B. Jump, presidente e CEO da MedAlliance. "Muitas empresas vêm tentando há anos trazer o sirolimus para os Estados Unidos e estamos muito satisfeitos com nossa equipe por alcançar esse marco significativo. Os pacientes dos EUA agora terão uma alternativa ao balão eluidor de paclitaxel, respondendo às preocupações expressas pela FDA."

O SELUTION SLR recebeu o selo CE para o tratamento de doença arterial periférica em fevereiro de 2020 e para o tratamento de doença arterial coronariana em maio de 2020. A Administração de Alimentos e Medicamentos dos EUA (FDA) concedeu ao SELUTION SLR quatro designações inovadoras: para o tratamento de lesões ateroscleróticas em artérias coronárias nativas, reestenose intra-stent coronariana, indicações periféricas abaixo do joelho e fístula arteriovenosa.

Em agosto de 2021, o primeiro dos mais de três mil pacientes foi inscrito em um estudo coronário randomizado controlado inovador, que comparou o SELUTION SLR com um stent eluidor de limus, com poder de demonstrar superioridade. O SELUTION DeNovo é o maior estudo de balão eluidor de medicamentos já iniciado e tem o potencial de mudar a prática médica.

A tecnologia de balões eluidores de medicamentos da MedAlliance envolve microrreservatórios exclusivos feitos de polímero biodegradável misturado com o medicamento antirrestenótico sirolimus. Esses microrreservatórios proporcionam a liberação controlada e sustentada do medicamento por até 90 dias1. A liberação prolongada de sirolimus a partir de stents tem se mostrado altamente eficaz nas vasculaturas coronárias e periféricas. A CAT™ (Cell Adherent Technology), de propriedade da MedAlliance permite que os microrreservatórios sejam revestidos em balões e aderidos ao lúmen do vaso quando administrados por meio de um balão de angioplastia.

O SELUTION SLR está disponível atualmente na Europa e em todos os outros países onde o selo CE é reconhecido.

Sobre a MedAlliance 

A MedAlliance é uma empresa privada de tecnologia médica. Está sediada em Nyon, na Suíça, e possui escritórios na Alemanha, em Singapura, no Reino Unido e nos EUA. A MedAlliance é especializada no desenvolvimento de tecnologias inovadoras e na comercialização de produtos avançados que combinam dispositivos e medicamentos para o tratamento de doenças coronárias e periféricas. Para mais informações, acesse: www.medalliance.com

1   evidência de concentração de fármaco em microrreservatórios e tecidos – dados arquivados na M.A. Med Alliance SA

Contato para a imprensa: 

Richard Kenyon
[email protected]
+44 7831 569940

Foto: https://mma.prnewswire.com/media/1883511/MedAlliance.jpg
Logotipo: https://mma.prnewswire.com/media/1196864/MedAlliance_Logo.jpg

FONTE MedAlliance

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