Clinical Benefits of Tryton

  • T: Tryton – P: Provisional
  • *TVF: Cardiac death, TV-MI and ID-TVR
  • +MACE: Cardiac death, MI (Q-wave and non-Q-wave) and any TLR (including CABG)
  • °As compared to a provisional stenting strategy. Post-hoc Individual-patient-data pooled analysis on Outcomes Tryton for true bifurcations – Konigstein et al. – Catheter Cardiovasc Interv. 2018– not powered to show statistical differences.
  1. Post-Hoc Intended Cohort Analysis (SB RVD ≥2.25mm QCA) – not powered to show statistical differences
  2. RCT Dedicated Bifurcation Stent Vs. Provisional – Généreux, et al. -  JACC. 2015
  3. Outcomes Tryton Confirmatory Study Genereux et al. JACCInterv. 2016
  4. Outcomes TRYTON In Bifurcations Large Side Branches – RCT Subanalysis - Généreux et al. - CCI 2016 – not powered to show statistical differences
  5. Outcomes Tryton for true bifurcations: Individual-patient-data pooled analysis – Konigstein et al. – Catheter Cardiovasc Interv. 2018 as Post Hoc analysis in Medina 1,1,1; 0,1,1; or 1,0,1 in SB RVD >=2.25 by QCA – not powered to show statistical differences
  6. Tryton 5-year clinical FU – Green et al. – CRM 2018 in press
  7. 6M and 1Y clinical outcomes a patient-level pooled analysis of 8 registry studies - Grundeken et al - EuroInterv 2013
  8. TLR defined as any repeat treatment of a lesion located within the index coronary segment
  9. Device Success: Achievement of final in-stent residual stenosis <30% (by QCA) in SB using the assigned study device without malfunction
  10. Procedural Success: Achievement of a final in-stent diameter stenosis of <50% (by QCA) using the assigned device and with any adjunctive devices, without the occurrence of cardiac death, Q wave or non-Q wave MI, or repeat revascularization of the target lesion during the hospital stay
  11. Acute: within 24 hours; Subacute: ≥ 1 day - 30 days; Late: 31 days - 1 year; Very Late: > 1 year
  12. CACTUS - Columbo, et al. Circulation 2009; 119: 71-78
  13. BBC-One Hildick-Smith, et al. Circulation 2010; 121: 1235-1243
  14. DKCRUSH II Chen, et al. J Am Coll Card. 2011; 57: 914-920
  15. LEADERS Bifurcation subgroup Garg, et al. Euro Intervent. 2011; 6: 928-93
  16. LEADERS FREE Urban, et al. NEJM. 2015; 373:21
  17. BBK – Randomized trial on routine vs. Provisional T-stenting in the treatment of de novo coronary bifurcation lesions – Ferenc et al. EHJ 2008
  18. Nordic I – Steigen et al. NORDIC I -Steigen et al- Circulation. 2006;114-1955-1961
  19. Nordic IV - Kumsars_Nordic-Baltic Bifurcation Study IV - TCT 2015
  20. NORDIC I Five (5) year results – Maeng et al - JACC 2013
  21. LEADERS - 5 Year Outcome of bifurc stenting using BES-SES - Grundeken et al EuroIntervention 2015
  22. Data on file with Tryton Inc.

CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. For healthcare professionals only. Prior to use, refer to the instruction for use supplied with this device for indications, contraindications, side effects, suggested procedure, warnings and precautions. WARNINGS: Use of the Tryton Side Branch Stent in appropriately sized main vessels and side branches is required for safe and effective performance of the device. Do not use the Tryton Stent in small side branches [<2.50 mm in diameter by visual assessment or <2.25 mm in diameter by quantitative coronary angiography (QCA)], as its use may lead to an increased risk of adverse cardiac events such as myocardial infarction and the need for repeat revascularization. To confirm appropriately-sized side branch diameters, the diameter of the pre-dilation balloon inflated to nominal pressure may be used as a reference. Alternatively, the use of quantitative imaging methods such as on-line quantitative coronary angiography, intravascular ultrasound or optimal coherence tomography should be considered. Use of the Tryton Side Branch Stent, as with percutaneous coronary stent implantation procedures in general, is known to be associated with the following risks: Vessel thrombosis. Increased length of hospital stay relative to those of coronary balloon angioplasty alone. Judicious selection of patients to receive this device rather than balloon angioplasty alone is strongly advised. infection secondary to contamination of the stent may lead to thrombosis, pseudoaneurysm or rupture. The stent may cause spasm, distal embolization, thrombus, or could migrate from the site of implantation. Excessive dilatation of the artery may cause vessel rupture and life-threatening bleeding. Stents may not be fully expanded during deployment, particularly in resistant lesions. Stent dislodgment from the balloon surface during deployment and/or dislodgment from the target site post-deployment can occur. Major bleeding.