The ONLY Branched Frozen Elephant Trunk Device with Plexus and Ante-Flo™ configurations

Thoraflex™ Hybrid device comprises of a gelatin sealed proximal single or multi-branched graft and distal stent. It is designed for intuitive and accurate deployment, enables earlier patient re-warming, reduced myocardial, lower body ischaemia and operating times.1-4

Product availability subject to local regulatory approval.5

Thoraflex™ Hybrid Plexus and Thoraflex™ Hybrid Plexus
 

The ONLY Branched Frozen Elephant Trunk Device with Plexus and Ante-Flo™ configurations

Part II

Part III

Part IIII

The Thoraflex™ Hybrid device allows a one stage procedure, adds to the Frozen Elephant Trunk (FET) technique concept for treating aortic arch and descending aortic disease, while increasing the choice for the surgeon in the treatment of complex and diverse aortic arch pathology.5

The device is fully gelatin sealed and comprises of a woven polyester proximal Gelweave™ Siena arch graft pre-sewn to a distal stent, ensures easier and safer anastomosis of the prosthesis to the aorta reducing the haemodynamic traction on the anastomosis.2

The new and expanded range of Thoraflex™ Hybrid includes both Plexus and Ante-Flo™ designs and smaller stent diameter sizes of 24 and 26mm.4

The Ante-Flo™ design allows the island technique to be performed which, together with the smaller stent sizes, enables a larger patient population to be treated.4

Other new features include a more conformable flexible shaft allowing easier shaping to suit patient anatomy and system trackability, a redesigned intuitive rapid release sheath splitter clip mechanism for enhanced deployment performance and optimised arch vessel branch geometry.4

Thoraflex™ Hybrid used for the FET technique has been shown to allow earlier patient re-warming, reduced myocardial, lower body ischaemia and operating times.1-3

Implantation of the Thoraflex™ Hybrid device resulted in excellent outcomes and beneficial aortic remodelling during follow up.6

Find out all you need to know about the ONLY multi-branched "Frozen Elephant Trunk" Prothesis:

Download Thoraflex™ Hybrid Product Brochure

References

  1. Di Marco L et al. The Thoraflex™ Hybrid frozen elephant trunk device: The Bologna experience.
    J Vasc Endovasc Surg, 2014; 21(3), 117-23

  2. Ruggieri VG et al. Multibranched hybrid device for frozen elephant trunk: what does it change? Thoracic & Cardiovasc Surg, July 2015; 15(1), 253-255

  3. Maselli D et al. Frozen elephant trunk with Thoraflex™ Hybrid prosthesis: early results of the prospective THORA-FET registry. AATS Aortic Symposium, May 2016, NY, USA

  4. Clinical evaluation report for Thoraflex™ Hybrid device design dossier 019, Issue 4, Feb 2016

  5. Shrestha M et al. Total aortic arch replacement with a novel four-branched frozen elephant trunk graft: first-in-man results. European Journal of Cardio-Thoracic Surg, 2013;43, 406–410

  6. Shrestha M et al. Total aortic arch replacement with a novel 4-branched frozen elephant trunk prosthesis: single-centre results of the first 100 patients. J Thoracic and Cardiovasc Surg, July 2016; 152(1), 148-159

Clinical References

  1. Di Marco L et al. The Thoraflex™ Hybrid frozen elephant trunk device: the Bologna experience. J Vasc Endovasc Surg, 2014; 21(3), 117-23

  2. Clinical evaluation report for Thoraflex™ Hybrid device design dossier 019, Issue 4, Feb 2016

  3. Ruggieri VG et al. Multibranched hybrid device for frozen elephant trunk: what does it change? J Thoracic & Cardiovasc Surg, July 2015; 15(1), 253-255

  4. Maselli D et al. Frozen elephant trunk with Thoraflex™ Hybrid prosthesis: early results of the prospective THORA-FET registry. AATS Aortic Symposium, May 2016, NY, USA

  5. Shrestha M et al. Total aortic arch replacement with a novel 4-branched frozen elephant trunk prosthesis: single-centre results of the first 100 patients. J Thoracic and Cardiovasc Surg, July 2016; 152(1), 148-159

  6. Shrestha M et al. Innovative products and emerging implantation techniques. First-in-man results with a novel 4-branched elephant trunk graft for total aortic arch replacement. EACTS Symposium, Oct. 2011

  7. Di Bartolomeo R et al. The Bologna Experience with the Thoraflex Hybrid Device. Future Cardiology, 2015; (11)1, 39-43

  8. Shrestha M et al. The Elephant Trunk is Freezing: The Hannover Experience. J Thoracic and Cardiovasc Surg, 2015;149(5), 1286-1293

  9. Zembala M et al. The use of a new hybrid stentgraft for the repair of extensive thoracic aortic aneurysms with the frozen elephant trunk method – first Polish experiences. Kardiochirurgia i Torakochirurgia Polska, 2014;11(3), 257-263

  10. Shrestha M et al. Total aortic arch replacement with a novel four-branched frozen elephant trunk graft: first-in-man results. European Journal of Cardio-Thoracic Surg, 2013;43, 406–410

  11. Urbanski P et al. Non-anatomical implantation of supra-aortic branches for customizing the standard form of Thoraflex™ Hybrid prosthesis to a patient’s anatomical requirements. Interactive CardioVascular and Thoracic Surg, 2016; 22,109–111