Ranger™

Cateter com Balão para PTA Revestido com Paclitaxel

Ranger™ Ranger™ Cateter com Balão para PTA Revestido com Paclitaxel image
Ranger™ Ranger™ Cateter com Balão para PTA Revestido com Paclitaxel image
Ranger™ Ranger™ Cateter com Balão para PTA Revestido com Paclitaxel

Apoiado por múltiplos Ensaios Controlados Randomizados de Nível 1, o Ranger proporciona resultados excepcionais, liberação sem esforço e transferência de medicamento eficiente.

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Brochura do Cateter com Balão para PTA Revestido com Paclitaxel Ranger

Brochura do Ranger

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Detalhes do Produto

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Resultados Excepcionais

O Ranger demonstrou resultados consistentes com cerca de 90% de patência em 12 meses nos Ensaios Controlados Randomizados COMPARE e RANGER II SFA.1
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Liberação Sem Esforço

Construído sobre a plataforma de balão Sterling de 0,018" líder de mercado2 com compatibilidade para fios-guia de 0,014"/0,018", o Ranger possui o menor perfil de entrada de ponta.3
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Transferência de Medicamento Eficiente

O Ranger é um DCB de baixa dose com um revestimento de TransPax formulado de forma exclusiva que resulta em uma transferência de medicamento altamente eficiente. Isto permite uma liberação de medicamento extremamente direcionada, alcançando cerca de 90% de patência primária1, com a menor quantidade de particulados posteriores4 e baixa exposição sistêmica de medicamento ao paciente.5
Ensaio Controlado Randomizado COMPARE: Resultados de 12 Meses apresentados pela Dra. Sabine Steiner. LINC 2020. Desfechos Primários de 12 Meses: Patência Primária Binária = 83,0% para o DCB Ranger e 81,5% para o DCB IN.PACT (Pnão-inferioridade <0,01). Ausência de Eventos Adversos Maiores = 91,0% para o DCB Ranger e 92,6% para o DCB IN.PACT (Pnão-inferioridade <0,01). 

Ensaio Controlado Randomizado Ranger II SFA: Resultados de 12 Meses apresentados por Marianne Brodmann. LINC 2020. Desfechos Primários de 12 Meses: Patência Primária Binária = 82,9% para o DCB Ranger e 66,3% para o DCB PTA (p= 0,0017). Ausência de Eventos Adversos Maiores = 94,1% para o DCB Ranger e 83,5% para o DCB PTA (Pnão-inferioridade <0,0001).
 

Matriz de Tamanhos do Ranger

Balon (m) 40mm 60mm 80mm 100mm 120mm 150mm 200mm
2mm     4F 4F 4F 4F  
2.5mm     4F 4F 4F 4F  
3mm     4F 4F 4F 4F  
3.5mm     4F 4F 4F 4F  
4mm 5F 5F 4F/5F 4F/5F 4F 4F 5F
5mm 5F 5F 5F 5F 5F 5F 5F
6mm 5F 5F 5F 5F 5F 5F 5F
7mm 6F 6F 6F 6F 6F 6F 6F
8mm 5F 5F 5F        
 

Informações de Pedido de UPN do Ranger

UPN Descrição ANVISA
H74939219400380 RANGER DCB OTW 4.0 MM X 30 MM 10341350986
H74939219400480 RANGER DCB OTW 4.0 MM X 40 MM 10341350986
H74939219400680 RANGER DCB OTW 4.0 MM X 60 MM 10341350986
H74939219400880 RANGER DCB OTW 4.0 MM X 80 MM 10341350986
H74939219401080 RANGER DCB OTW 4.0 MM X 100 MM 10341350986
H74939219500380 RANGER DCB OTW 5.0 MM X 30 MM 10341350986
H74939219500480 RANGER DCB OTW 5.0 MM X 40 MM 10341350986
H74939219500680 RANGER DCB OTW 5.0 MM X 60 MM 10341350986
H74939219500880 RANGER DCB OTW 5.0 MM X 80 MM 10341350986
H74939219501080 RANGER DCB OTW 5.0 MM X 100 MM 10341350986
H74939219600380 RANGER DCB OTW 6.0 MM X 30 MM 10341350986
H74939219600480 RANGER DCB OTW 6.0 MM X 40 MM 10341350986
H74939219600680 RANGER DCB OTW 6.0 MM X 60 MM 10341350986
H74939219700380 RANGER DCB OTW 7.0 MM X 30 MM 10341350986
H74939219700480 RANGER DCB OTW 7.0 MM X 40 MM 10341350986
H74939219800380 RANGER DCB OTW 8.0 MM X 30 MM 10341350986
H74939219800480 RANGER DCB OTW 8.0 MM X 40 MM 10341350986
H74939219400310 RANGER DCB OTW 4.0 MM X 30 MM 10341350986
H74939219400410 RANGER DCB OTW 4.0 MM X 40 MM 10341350986
H74939219400610 RANGER DCB OTW 4.0 MM X 60 MM 10341350986
H74939219500310 RANGER DCB OTW 5.0 MM X 30 MM 10341350986
H74939219500410 RANGER DCB OTW 5.0 MM X 40 MM 10341350986
H74939219500610 RANGER DCB OTW 5.0 MM X 60 MM 10341350986
H74939219500810 RANGER DCB OTW 5.0 MM X 80 MM 10341350986
H74939219501010 RANGER DCB OTW 5.0 MM X 100 MM 10341350986
H74939219600310 RANGER DCB OTW 6.0 MM X 30 MM 10341350986
H74939219600410 RANGER DCB OTW 6.0 MM X 40 MM 10341350986
H74939219600610 RANGER DCB OTW 6.0 MM X 60 MM 10341350986
H74939219700310 RANGER DCB OTW 7.0 MM X 30 MM 10341350986
H74939219700410 RANGER DCB OTW 7.0 MM X 40 MM 10341350986
H74939219800310 RANGER DCB OTW 8.0 MM X 30 MM 10341350986
H74939219800410 RANGER DCB OTW 8.0 MM X 40 MM 10341350986
H74939220200890 RANGER SL DCB OTW 2.00MM X 80M 10341350986
H74939220201090 RANGER SL DCB OTW 2.00MM X 100 10341350986
H74939220201290 RANGER SL DCB OTW 2.00 MM X 12 10341350986
H74939220201590 RANGER SL DCB OTW 2.00MM X 150 10341350986
H74939220250890 RANGER SL DCB OTW 2.50MM X 80M 10341350986
H74939220251090 RANGER SL DCB OTW 2.50MM X 100 10341350986
H74939220251290 RANGER SL DCB OTW 2.50MM X 120 10341350986
H74939220251590 RANGER SL DCB OTW 2.50MM X 150 10341350986
H74939220300890 RANGER SL DCB OTW 3.00MM X 80M 10341350986
H74939220301090 RANGER SL DCB OTW 3.00MM X 100 10341350986
H74939220301290 RANGER SL DCB OTW 3.00MM X 120 10341350986
H74939220301590 RANGER SL DCB OTW 3.00MM X 150 10341350986
H74939220350890 RANGER SL DCB OTW 3.50MM X 80M 10341350986
H74939220351090 RANGER SL DCB OTW 3.5MM X 100M 10341350986
H74939220351290 RANGER SL DCB OTW 3.50MM X 120 10341350986
H74939220351590 RANGER SL DCB OTW 3.50MM X 150 10341350986
H74939220401290 RANGER SL DCB OTW 4.00MM X 120 10341350986
H74939220401590 RANGER SL DCB OTW 4.00MM X 150 10341350986
H74939220200810 RANGER SL DCB OTW 2.00MM X 80M 10341350986
H74939220201010 RANGER SL DCB OTW 2.00MM X 100 10341350986
H74939220201210 RANGER SL DCB OTW 2.00MM X 120 10341350986
H74939220201510 RANGER SL DCB OTW 2.00MM X 150 10341350986
H74939220250810 RANGER SL DCB OTW 2.50MM X 80M 10341350986
H74939220251010 RANGER SL DCB OTW 2.50MM X 100 10341350986
H74939220251210 RANGER SL DCB OTW 2.50MM X 120 10341350986
H74939220251510 RANGER SL DCB OTW 2.50MM X 150 10341350986
H74939220300810 RANGER SL DCB OTW 3.00MM X 80M 10341350986
H74939220301010 RANGER SL DCB OTW 3.00MM X 100 10341350986
H74939220301210 RANGER SL DCB OTW 3.00MM X 120 10341350986
H74939220301510 RANGER SL DCB OTW 3.00MM X 150 10341350986
H74939220350810 RANGER SL DCB OTW 3.50MM X 80M 10341350986
H74939220351010 RANGER SL DCB OTW 3.50MM X 100 10341350986
H74939220351210 RANGER SL DCB OTW 3.50MM X 120 10341350986
H74939220351510 RANGER SL DCB OTW 3.50MM X 150 10341350986
H74939220400810 RANGER SL DCB OTW 4.00MM X 80M 10341350986
H74939220401010 RANGER SL DCB OTW 4.00MM X 100 10341350986
H74939220401210 RANGER SL DCB OTW 4.00MM X 120 10341350986
H74939220401510 RANGER SL DCB OTW 4.00MM X 150 10341350986
H74939319402090 RANGER DCB 4X200MM 90CM 10341350986
H74939319402010 RANGER DCB 4X200MM 150CM 10341350986
H74939219600880 RANGER DCB OTW 6.0 MM X 80 MM 10341350987
H74939219601080 RANGER DCB OTW 6.0 MM X 100 MM 10341350987
H74939219700680 RANGER DCB OTW 7.0 MM X 60 MM 10341350987
H74939219700880 RANGER DCB OTW 7.0 MM X 80 MM 10341350987
H74939219701080 RANGER DCB OTW 7.0 MM X 100 MM 10341350987
H74939219800680 RANGER DCB OTW 8.0 MM X 60 MM 10341350987
H74939219800880 RANGER DCB OTW 8.0 MM X 80 MM 10341350987
H74939219600810 RANGER DCB OTW 6.0 MM X 80 MM 10341350987
H74939219601010 RANGER DCB OTW 6.0 MM X 100 MM 10341350987
H74939219700610 RANGER DCB OTW 7.0 MM X 60 MM 10341350987
H74939219700810 RANGER DCB OTW 7.0 MM X 80 MM 10341350987
H74939219701010 RANGER DCB OTW 7.0 MM X 100 MM 10341350987
H74939219800610 RANGER DCB OTW 8.0 MM X 60 MM 10341350987
H74939219800810 RANGER DCB OTW 8.0 MM X 80 MM 10341350987
H74939319501290 RANGER DCB 5X120MM 90CM 10341350987
H74939319501590 RANGER DCB 5X150MM 90CM 10341350987
H74939319502090 RANGER DCB 5X200MM 90CM 10341350987
H74939319601290 RANGER DCB 6X120MM 90CM 10341350987
H74939319601590 RANGER DCB 6X150MM 90CM 10341350987
H74939319602090 RANGER DCB 6X200MM 90CM 10341350987
H74939319701290 RANGER DCB 7X120MM 90CM 10341350987
H74939319701590 RANGER DCB 7X150MM 90CM 10341350987
H74939319702090 RANGER DCB 7X200MM 90CM 10341350987
H74939319501210 RANGER DCB 5X120MM 150CM 10341350987
H74939319501510 RANGER DCB 5X150MM 150CM 10341350987
H74939319502010 RANGER DCB 5X200MM 150CM 10341350987
H74939319601210 RANGER DCB 6X120MM 150CM 10341350987
H74939319601510 RANGER DCB 6X150MM 150CM 10341350987
H74939319602010 RANGER DCB 6X200MM 150CM 10341350987
H74939319701210 RANGER DCB 7X120MM 150CM 10341350987
H74939319701510 RANGER DCB 7X150MM 150CM 10341350987
H74939319702010 RANGER DCB 7X200MM 150CM 10341350987
 
  1. COMPARE Clinical Trial 12-Month Full Cohort Results presented by Sabine Steiner, MD. LINC 2020. K-M Primary Patency = 88.4%. RANGER II SFA Pivotal Trial 12-Month Results presented by Marianne Brodmann. LINC 2020. K-M Primary Patency = 89.8%.
  2. DRG data, CY 2019, 0.018” PTA Balloons.
  3. Boston Scientific Data on File. Ranger Catheter Competitive Testing Report, 92517674. Tip entry profile measurements taken from 6 x 120 devices.
  4. Gongora et al. Comparative Drug-Coated Balloon Study. JACC Cardiovasc Interv. 2015doi.org/10.1016/j.jcin.2015.03.020.
  5. RANGER II SFA PK Substudy presented by Ravish Sachar, MD. VIVA 2019. 

 

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