Ranger™

Cateter com Balão para PTA Revestido com Paclitaxel

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

Brochura do Cateter com Balão para PTA Revestido com Paclitaxel Ranger

Brochura do Ranger

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Detalhes do Produto
Matriz de Tamanhos do Ranger™
Informações de Pedido de UPN do Ranger™

Detalhes do Produto

  outcome icon

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
  deliverability icon

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)40mm60mm80mm100mm120mm150mm200mm
2mm  4F4F4F4F 
2.5mm  4F4F4F4F 
3mm  4F4F4F4F 
3.5mm  4F4F4F4F 
4mm5F5F4F/5F4F/5F4F4F5F
5mm5F5F5F5F5F5F5F
6mm5F5F5F5F5F5F5F
7mm6F6F6F6F6F6F6F
8mm5F5F5F    
 

Informações de Pedido de UPN do Ranger™

UPNDescriçãoANVISA
H74939219400380RANGER DCB OTW 4.0 MM X 30 MM10341350986
H74939219400480RANGER DCB OTW 4.0 MM X 40 MM10341350986
H74939219400680RANGER DCB OTW 4.0 MM X 60 MM10341350986
H74939219400880RANGER DCB OTW 4.0 MM X 80 MM10341350986
H74939219401080RANGER DCB OTW 4.0 MM X 100 MM10341350986
H74939219500380RANGER DCB OTW 5.0 MM X 30 MM10341350986
H74939219500480RANGER DCB OTW 5.0 MM X 40 MM10341350986
H74939219500680RANGER DCB OTW 5.0 MM X 60 MM10341350986
H74939219500880RANGER DCB OTW 5.0 MM X 80 MM10341350986
H74939219501080RANGER DCB OTW 5.0 MM X 100 MM10341350986
H74939219600380RANGER DCB OTW 6.0 MM X 30 MM10341350986
H74939219600480RANGER DCB OTW 6.0 MM X 40 MM10341350986
H74939219600680RANGER DCB OTW 6.0 MM X 60 MM10341350986
H74939219700380RANGER DCB OTW 7.0 MM X 30 MM10341350986
H74939219700480RANGER DCB OTW 7.0 MM X 40 MM10341350986
H74939219800380RANGER DCB OTW 8.0 MM X 30 MM10341350986
H74939219800480RANGER DCB OTW 8.0 MM X 40 MM10341350986
H74939219400310RANGER DCB OTW 4.0 MM X 30 MM10341350986
H74939219400410RANGER DCB OTW 4.0 MM X 40 MM10341350986
H74939219400610RANGER DCB OTW 4.0 MM X 60 MM10341350986
H74939219500310RANGER DCB OTW 5.0 MM X 30 MM10341350986
H74939219500410RANGER DCB OTW 5.0 MM X 40 MM10341350986
H74939219500610RANGER DCB OTW 5.0 MM X 60 MM10341350986
H74939219500810RANGER DCB OTW 5.0 MM X 80 MM10341350986
H74939219501010RANGER DCB OTW 5.0 MM X 100 MM10341350986
H74939219600310RANGER DCB OTW 6.0 MM X 30 MM10341350986
H74939219600410RANGER DCB OTW 6.0 MM X 40 MM10341350986
H74939219600610RANGER DCB OTW 6.0 MM X 60 MM10341350986
H74939219700310RANGER DCB OTW 7.0 MM X 30 MM10341350986
H74939219700410RANGER DCB OTW 7.0 MM X 40 MM10341350986
H74939219800310RANGER DCB OTW 8.0 MM X 30 MM10341350986
H74939219800410RANGER DCB OTW 8.0 MM X 40 MM10341350986
H74939220200890RANGER SL DCB OTW 2.00MM X 80M10341350986
H74939220201090RANGER SL DCB OTW 2.00MM X 10010341350986
H74939220201290RANGER SL DCB OTW 2.00 MM X 1210341350986
H74939220201590RANGER SL DCB OTW 2.00MM X 15010341350986
H74939220250890RANGER SL DCB OTW 2.50MM X 80M10341350986
H74939220251090RANGER SL DCB OTW 2.50MM X 10010341350986
H74939220251290RANGER SL DCB OTW 2.50MM X 12010341350986
H74939220251590RANGER SL DCB OTW 2.50MM X 15010341350986
H74939220300890RANGER SL DCB OTW 3.00MM X 80M10341350986
H74939220301090RANGER SL DCB OTW 3.00MM X 10010341350986
H74939220301290RANGER SL DCB OTW 3.00MM X 12010341350986
H74939220301590RANGER SL DCB OTW 3.00MM X 15010341350986
H74939220350890RANGER SL DCB OTW 3.50MM X 80M10341350986
H74939220351090RANGER SL DCB OTW 3.5MM X 100M10341350986
H74939220351290RANGER SL DCB OTW 3.50MM X 12010341350986
H74939220351590RANGER SL DCB OTW 3.50MM X 15010341350986
H74939220401290RANGER SL DCB OTW 4.00MM X 12010341350986
H74939220401590RANGER SL DCB OTW 4.00MM X 15010341350986
H74939220200810RANGER SL DCB OTW 2.00MM X 80M10341350986
H74939220201010RANGER SL DCB OTW 2.00MM X 10010341350986
H74939220201210RANGER SL DCB OTW 2.00MM X 12010341350986
H74939220201510RANGER SL DCB OTW 2.00MM X 15010341350986
H74939220250810RANGER SL DCB OTW 2.50MM X 80M10341350986
H74939220251010RANGER SL DCB OTW 2.50MM X 10010341350986
H74939220251210RANGER SL DCB OTW 2.50MM X 12010341350986
H74939220251510RANGER SL DCB OTW 2.50MM X 15010341350986
H74939220300810RANGER SL DCB OTW 3.00MM X 80M10341350986
H74939220301010RANGER SL DCB OTW 3.00MM X 10010341350986
H74939220301210RANGER SL DCB OTW 3.00MM X 12010341350986
H74939220301510RANGER SL DCB OTW 3.00MM X 15010341350986
H74939220350810RANGER SL DCB OTW 3.50MM X 80M10341350986
H74939220351010RANGER SL DCB OTW 3.50MM X 10010341350986
H74939220351210RANGER SL DCB OTW 3.50MM X 12010341350986
H74939220351510RANGER SL DCB OTW 3.50MM X 15010341350986
H74939220400810RANGER SL DCB OTW 4.00MM X 80M10341350986
H74939220401010RANGER SL DCB OTW 4.00MM X 10010341350986
H74939220401210RANGER SL DCB OTW 4.00MM X 12010341350986
H74939220401510RANGER SL DCB OTW 4.00MM X 15010341350986
H74939319402090RANGER DCB 4X200MM 90CM10341350986
H74939319402010RANGER DCB 4X200MM 150CM10341350986
H74939219600880RANGER DCB OTW 6.0 MM X 80 MM10341350987
H74939219601080RANGER DCB OTW 6.0 MM X 100 MM10341350987
H74939219700680RANGER DCB OTW 7.0 MM X 60 MM10341350987
H74939219700880RANGER DCB OTW 7.0 MM X 80 MM10341350987
H74939219701080RANGER DCB OTW 7.0 MM X 100 MM10341350987
H74939219800680RANGER DCB OTW 8.0 MM X 60 MM10341350987
H74939219800880RANGER DCB OTW 8.0 MM X 80 MM10341350987
H74939219600810RANGER DCB OTW 6.0 MM X 80 MM10341350987
H74939219601010RANGER DCB OTW 6.0 MM X 100 MM10341350987
H74939219700610RANGER DCB OTW 7.0 MM X 60 MM10341350987
H74939219700810RANGER DCB OTW 7.0 MM X 80 MM10341350987
H74939219701010RANGER DCB OTW 7.0 MM X 100 MM10341350987
H74939219800610RANGER DCB OTW 8.0 MM X 60 MM10341350987
H74939219800810RANGER DCB OTW 8.0 MM X 80 MM10341350987
H74939319501290RANGER DCB 5X120MM 90CM10341350987
H74939319501590RANGER DCB 5X150MM 90CM10341350987
H74939319502090RANGER DCB 5X200MM 90CM10341350987
H74939319601290RANGER DCB 6X120MM 90CM10341350987
H74939319601590RANGER DCB 6X150MM 90CM10341350987
H74939319602090RANGER DCB 6X200MM 90CM10341350987
H74939319701290RANGER DCB 7X120MM 90CM10341350987
H74939319701590RANGER DCB 7X150MM 90CM10341350987
H74939319702090RANGER DCB 7X200MM 90CM10341350987
H74939319501210RANGER DCB 5X120MM 150CM10341350987
H74939319501510RANGER DCB 5X150MM 150CM10341350987
H74939319502010RANGER DCB 5X200MM 150CM10341350987
H74939319601210RANGER DCB 6X120MM 150CM10341350987
H74939319601510RANGER DCB 6X150MM 150CM10341350987
H74939319602010RANGER DCB 6X200MM 150CM10341350987
H74939319701210RANGER DCB 7X120MM 150CM10341350987
H74939319701510RANGER DCB 7X150MM 150CM10341350987
H74939319702010RANGER DCB 7X200MM 150CM10341350987
 
  1. Steiner S, Schmidt A, Zeller T, Tepe G, Thieme M, Maiwald L, Schröder H, Euringer W, Ulrich M, Brechtel K, Brucks S, Blessing E, Schuster J, Langhoff R, Schellong S, Weiss N, Scheinert D. “COMPARE: Prospective, Randomized, Non-Inferiority Trial of High- vs. Low-Dose Paclitaxel Drug-Coated Balloons for Femoropopliteal Interventions.” European Heart Journal, vol. 41, no. 27, 2020, pp. 2541-2552. DOI: 10.1093/eurheartj/ehaa049. Clinical Trial Registration: NCT02701543.DRG data, CY 2019, 0.018” PTA Balloons.
  2. Boston Scientific Data on File. Ranger Catheter Competitive Testing Report, 92517674. Tip entry profile measurements taken from 6 x 120 devices.
  3. Gongora et al. Comparative Drug-Coated Balloon Study. JACC Cardiovasc Interv. 2015doi.org/10.1016/j.jcin.2015.03.020.
  4. Sachar R, Soga Y, Ansari MM, Kozuki A, Lopez L, Brodmann M, Schroë H, Ramanath VS, Diaz-Cartelle J, Zeller T, on behalf of the RANGER II SFA Investigators. “1-Year Results From the RANGER II SFA Randomized Trial of the Ranger Drug-Coated Balloon.” JACC: Cardiovascular Interventions, vol. 14, no. 10, 2021, pp. 1123-1133. DOI: 10.1016/j.jcin.2021.03.021. 

 

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