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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Detalhes do Produto
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Resultados ExcepcionaisO 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 EsforçoConstruído 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 EficienteO 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 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 |
H74939670201010 | Ranger DCB OTW 2.0mm x 100mm, 150cm | 10341350986 |
H74939670201090 | Ranger DCB OTW 2.0mm x 100mm, 90cm | 10341350986 |
H74939670201290 | Ranger DCB OTW 2.0mm x 120mm, 90cm | 10341350986 |
H74939670201510 | Ranger DCB OTW 2.0mm x 150mm, 150cm | 10341350986 |
H74939670201590 | Ranger DCB OTW 2.0mm x 150mm, 90cm | 10341350986 |
H74939670200810 | Ranger DCB OTW 2.0mm x 80mm, 150cm | 10341350986 |
H74939670200890 | Ranger DCB OTW 2.0mm x 80mm, 90cm | 10341350986 |
H74939670201210 | Ranger DCB OTW 2.0mm x 120mm, 150cm | 10341350986 |
H74939670251010 | Ranger DCB OTW 2.5mm x 100mm, 150cm | 10341350986 |
H74939670251090 | Ranger DCB OTW 2.5mm x 100mm, 90cm | 10341350986 |
H74939670251210 | Ranger DCB OTW 2.5mm x 120mm, 150cm | 10341350986 |
H74939670251290 | Ranger DCB OTW 2.5mm x 120mm, 90cm | 10341350986 |
H74939670251510 | Ranger DCB OTW 2.5mm x 150mm, 150cm | 10341350986 |
H74939670251590 | Ranger DCB OTW 2.5mm x 150mm, 90cm | 10341350986 |
H74939670250810 | Ranger DCB OTW 2.5mm x 80mm, 150cm | 10341350986 |
H74939670250890 | Ranger DCB OTW 2.5mm x 80mm, 90cm | 10341350986 |
H74939670301010 | Ranger DCB OTW 3.0mm x 100mm, 150cm | 10341350986 |
H74939670301090 | Ranger DCB OTW 3.0mm x 100mm, 90cm | 10341350986 |
H74939670301210 | Ranger DCB OTW 3.0mm x 120mm, 150cm | 10341350986 |
H74939670301290 | Ranger DCB OTW 3.0mm x 120mm, 90cm | 10341350986 |
H74939670301510 | Ranger DCB OTW 3.0mm x 150mm, 150cm | 10341350986 |
H74939670300810 | Ranger DCB OTW 3.0mm x 80mm, 150cm | 10341350986 |
H74939670300890 | Ranger DCB OTW 3.0mm x 80mm, 90cm | 10341350986 |
H74939670301590 | Ranger DCB OTW 3.0mm x 150mm, 90cm | 10341350986 |
H74939670351290 | Ranger DCB OTW 3.5mm x 120mm, 90cm | 10341350986 |
H74939670351010 | Ranger DCB OTW 3.5mm x 100mm, 150cm | 10341350986 |
H74939670351090 | Ranger DCB OTW 3.5mm x 100mm, 90cm | 10341350986 |
H74939670351210 | Ranger DCB OTW 3.5mm x 120mm, 150cm | 10341350986 |
H74939670351510 | Ranger DCB OTW 3.5mm x 150mm, 150cm | 10341350986 |
H74939670351590 | Ranger DCB OTW 3.5mm x 150mm, 90cm | 10341350986 |
H74939670350810 | Ranger DCB OTW 3.5mm x 80mm, 150cm | 10341350986 |
H74939670350890 | Ranger DCB OTW 3.5mm x 80mm, 90cm | 10341350986 |
H74939670401080 | Ranger DCB OTW 4.0mm x 100mm, 80cm | 10341350986 |
H74939670400310 | Ranger DCB OTW 4.0mm x 30mm, 135cm | 10341350986 |
H74939670400380 | Ranger DCB OTW 4.0mm x 30mm, 80cm | 10341350986 |
H74939670400410 | Ranger DCB OTW 4.0mm x 40mm, 135cm | 10341350986 |
H74939670400480 | Ranger DCB OTW 4.0mm x 40mm, 80cm | 10341350986 |
H74939670400610 | Ranger DCB OTW 4.0mm x 60mm, 135cm | 10341350986 |
H74939670400680 | Ranger DCB OTW 4.0mm x 60mm, 80cm | 10341350986 |
H74939670400880 | Ranger DCB OTW 4.0mm x 80mm, 80cm | 10341350986 |
H74939670401010 | Ranger DCB OTW 4.0mm x 100mm, 150cm | 10341350986 |
H74939670401210 | Ranger DCB OTW 4.0mm x 120mm, 150cm | 10341350986 |
H74939670401290 | Ranger DCB OTW 4.0mm x 120mm, 90cm | 10341350986 |
H74939670401510 | Ranger DCB OTW 4.0mm x 150mm, 150cm | 10341350986 |
H74939670401590 | Ranger DCB OTW 4.0mm x 150mm, 90cm | 10341350986 |
H74939670400810 | Ranger DCB OTW 4.0mm x 80mm, 150cm | 10341350986 |
H74939670501010 | Ranger DCB OTW 5.0mm x 100mm, 135cm | 10341350986 |
H74939670501080 | Ranger DCB OTW 5.0mm x 100mm, 80cm | 10341350986 |
H74939670500310 | Ranger DCB OTW 5.0mm x 30mm, 135cm | 10341350986 |
H74939670500380 | Ranger DCB OTW 5.0mm x 30mm, 80cm | 10341350986 |
H74939670500410 | Ranger DCB OTW 5.0mm x 40mm, 135cm | 10341350986 |
H74939670500480 | Ranger DCB OTW 5.0mm x 40mm, 80cm | 10341350986 |
H74939670500610 | Ranger DCB OTW 5.0mm x 60mm, 135cm | 10341350986 |
H74939670500680 | Ranger DCB OTW 5.0mm x 60mm, 80cm | 10341350986 |
H74939670500810 | Ranger DCB OTW 5.0mm x 80mm, 135cm | 10341350986 |
H74939670500880 | Ranger DCB OTW 5.0mm x 80mm, 80cm | 10341350986 |
H74939670601010 | Ranger DCB OTW 6.0mm x 100mm, 135cm | 10341350987 |
H74939670601080 | Ranger DCB OTW 6.0mm x 100mm, 80cm | 10341350987 |
H74939670600310 | Ranger DCB OTW 6.0mm x 30mm, 135cm | 10341350986 |
H74939670600380 | Ranger DCB OTW 6.0mm x 30mm, 80cm | 10341350986 |
H74939670600410 | Ranger DCB OTW 6.0mm x 40mm, 135cm | 10341350986 |
H74939670600480 | Ranger DCB OTW 6.0mm x 40mm, 80cm | 10341350986 |
H74939670600610 | Ranger DCB OTW 6.0mm x 60mm, 135cm | 10341350986 |
H74939670600680 | Ranger DCB OTW 6.0mm x 60mm, 80cm | 10341350986 |
H74939670600810 | Ranger DCB OTW 6.0mm x 80mm, 135cm | 10341350987 |
H74939670600880 | Ranger DCB OTW 6.0mm x 80mm, 80cm | 10341350987 |
H74939670701010 | Ranger DCB OTW 7.0mm x 100mm, 135cm | 10341350987 |
H74939670701080 | Ranger DCB OTW 7.0mm x 100mm, 80cm | 10341350987 |
H74939670700310 | Ranger DCB OTW 7.0mm x 30mm, 135cm | 10341350986 |
H74939670700380 | Ranger DCB OTW 7.0mm x 30mm, 80cm | 10341350986 |
H74939670700410 | Ranger DCB OTW 7.0mm x 40mm, 135cm | 10341350986 |
H74939670700480 | Ranger DCB OTW 7.0mm x 40mm, 80cm | 10341350986 |
H74939670700610 | Ranger DCB OTW 7.0mm x 60mm, 135cm | 10341350987 |
H74939670700680 | Ranger DCB OTW 7.0mm x 60mm, 80cm | 10341350987 |
H74939670700810 | Ranger DCB OTW 7.0mm x 80mm, 135cm | 10341350987 |
H74939670700880 | Ranger DCB OTW 7.0mm x 80mm, 80cm | 10341350987 |
H74939670800310 | Ranger DCB OTW 8.0mm x 30mm, 135cm | 10341350986 |
H74939670800380 | Ranger DCB OTW 8.0mm x 30mm, 80cm | 10341350986 |
H74939670800410 | Ranger DCB OTW 8.0mm x 40mm, 135cm | 10341350986 |
H74939670800480 | Ranger DCB OTW 8.0mm x 40mm, 80cm | 10341350986 |
H74939670800610 | Ranger DCB OTW 8.0mm x 60mm, 135cm | 10341350987 |
H74939670800680 | Ranger DCB OTW 8.0mm x 60mm, 80cm | 10341350987 |
H74939670800810 | Ranger DCB OTW 8.0mm x 80mm, 135cm | 10341350987 |
H74939670800880 | Ranger DCB OTW 8.0mm x 80mm, 80cm | 10341350987 |
H74939670402010 | Ranger DCB OTW 4.0mm x 200mm, 150cm | 10341350986 |
H74939670402090 | Ranger DCB OTW 4.0mm x 200mm, 90cm | 10341350986 |
H74939670501210 | Ranger DCB OTW 5.0mm x 120mm, 150cm | 10341350987 |
H74939670501290 | Ranger DCB OTW 5.0mm x 120mm, 90cm | 10341350987 |
H74939670501510 | Ranger DCB OTW 5.0mm x 150mm, 150cm | 10341350987 |
H74939670501590 | Ranger DCB OTW 5.0mm x 150mm, 90cm | 10341350987 |
H74939670502010 | Ranger DCB OTW 5.0mm x 200mm, 150cm | 10341350987 |
H74939670502090 | Ranger DCB OTW 5.0mm x 200mm, 90cm | 10341350987 |
H74939670601210 | Ranger DCB OTW 6.0mm x 120mm, 150cm | 10341350987 |
H74939670601290 | Ranger DCB OTW 6.0mm x 120mm, 90cm | 10341350987 |
H74939670601510 | Ranger DCB OTW 6.0mm x 150mm, 150cm | 10341350987 |
H74939670601590 | Ranger DCB OTW 6.0mm x 150mm, 90cm | 10341350987 |
H74939670602010 | Ranger DCB OTW 6.0mm x 200mm, 150cm | 10341350987 |
H74939670602090 | Ranger DCB OTW 6.0mm x 200mm, 90cm | 10341350987 |
H74939670701210 | Ranger DCB OTW 7.0mm x 120mm, 150cm | 10341350987 |
H74939670701290 | Ranger DCB OTW 7.0mm x 120mm, 90cm | 10341350987 |
H74939670701510 | Ranger DCB OTW 7.0mm x 150mm, 150cm | 10341350987 |
H74939670701590 | Ranger DCB OTW 7.0mm x 150mm, 90cm | 10341350987 |
H74939670702010 | Ranger DCB OTW 7.0mm x 200mm, 150cm | 10341350987 |
H74939670702090 | Ranger DCB OTW 7.0mm x 200mm, 90cm | 10341350987 |
- 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.
- Boston Scientific Data on File. Ranger Catheter Competitive Testing Report, 92517674. Tip entry profile measurements taken from 6 x 120 devices.
- Gongora et al. Comparative Drug-Coated Balloon Study. JACC Cardiovasc Interv. 2015doi.org/10.1016/j.jcin.2015.03.020.
- 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.
