BioFreedom – the world’s first coronary stent system coated with BA9

Presentación del tema: "BioFreedom – the world’s first coronary stent system coated with BA9"— Transcripción de la presentación:

1 BioFreedom – the world’s first coronary stent system coated with BA9
BioFreedom – the world’s first coronary stent system coated with BA9. No polymer just stent and drug – no carriers, no permanent polymers or biodegradable polymers. The next natural progression in the development of the BioMatrix family of stents.

2 BioFreedom™: El primer BA9 DCS que combina las ventajas del DES y del BMS
Stent Platform 316 L Stainless Steel Strut thickness 0.0044” Crimped profile 0.043” (3.0mm) Polymer No polymeric drug carrier Drug Biolimus A9™ Dose Standard Dose: 15.6µg of BA9/mm stent length Release kinetics 50 hours/90% release Product Approval CE mark granted BioFreedom – the same stainless steel platform as BioMatrix Flex / Neo Flex which is 96%-98% free of drug at 28 days and as such becomes BMS stent-like around 28 days. The safety of a BMS with the effectiveness of a DES – giving you options for all your patients not just those who can take long DAPT regimens. I LIKE!

3 Ventajas de los stents con polímeros bioabsorbibles::
La inflamación resultante del polímero tiene un fuerte impacto sobre la seguridad y eficacia a largo plazo Los stents liberadores de droga con polímero durable han sido asociados a inflamación crónica y mala endotelización. Ventajas de los stents con polímeros bioabsorbibles:: Menor carga de Polímero Menor exposición al Polímero Reducción de DAPT Reducción de los riesgos con la interrupción de la DAPT Disminuición de la trombosis del stent may This proposition isn’t unique to Biosensors as we see here – Boston Scientific are now supporting the anti-polymer story with their new biodegradable polymer stent. The jury has returned its verdict – permanent polymer is not good (yet they are still promoting the Promus Premier).

4 Biosensors cree que BioFreedom tiene el potencial para reducir la DAPT
Biosensors believe in BioFreedom and we have invested heavily to get the answers everyone is asking about optimal DAPT. The data from this study will be available in 2015. Biosensors cree que BioFreedom tiene el potencial para reducir la DAPT

5 Estudio LEADERS Free, un diseño único
Double blinded design in a DES trial PI: Philip Urban Prospective, multi-center, multi-national, double blinded randomized trial High Bleeding Risk PCI population (ACS + Elective stable patients) Non-comers population 2500 patients in 65 centers worldwide BioFreedom™ DCS 1:1 randomization Gazelle™ BMS Clinical Follow-Up 1 mo 2 mo 4 mo yr yr Primary safety endpoint: Composite of cardiac death, MI, definite/probable stent thrombosis at 1 year (Non-inferiority) Primary efficacy endpoint: Clinically driven TLR at 1 year (Superiority) DAPT mandated for 1 month only, followed by long term SAPT Leaders Free will answer this question. It is double blinded, randomized, looking at high bleeding risk forgotten patients in 65 centres worldwide – 2500 recruited April 2014 Primary safety endpoint - Composite of cardiac death, MI, definite/probable stent thrombosis at 1 year (Non-inferiority) Primary efficacy endpoint - Clinically driven TLR at 1 year (Superiority) Two primary endpoints- safety and efficacy 1 month planned DAPT – distinguishing this from post-hoc studies only looking at interruptions at the judgment of the physicians (patients at low risk) Urban et al., Am Heart J. 2013; 165:

6 LEADERS Free: 2 stents con 1 mes de DAPT
Biosensors BioFreedom™ BA9 Drug-Coated Coronary Stent (DCS). Biosensors Gazelle™ Bare Metal Coronary Stent (BMS) 2 stents ASA mg OD, indefinidamente Clopidogrel 75 mg OD (u otro inhibidor P2Y12) por 1 mes DAPT Randomly selected one of two stents – BioFreedom and Biosenors BMS Gazelle BUT only one DAPT regimen ASA and Clopidogrel for 1 month only.

7 Importancia del Estudio
Primer estudio a gran escala de un DCS utilizando criterios de valoración clínicos Primer estudio prospectivo, randomizado, doble ciego para evaluar el uso de un stent activo con sólo un mes de DAPT Primer estudio prospectivo, randomizado, doble ciego para evaluar los resultados de PCI en pacientes considerados de alto riesgo de sangrado

8 Cúal será el impacto del Leaders Free en la práctica clínica?
Definirá los riesgos relativos a trombosis del stent y el sangrado en un subgrupo de pacientes desafiantes Tiene el potencial para traer los beneficios conocidos de una baja tasa de TLR a pacientes con alto riesgo de sangrado Read the slide !

9 BioFreedom iPad & Tech Specs

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11 STENT AUTOEXPANDIBLE PARA BIFURCACIONES

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