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

Thoraflex™ Hybrid device comprises 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 ischaemia, lower body ischaemia and operating times.1-4

  1. ThoraflexTM Hybrid Plexus facilitates individual arch vessel reconstruction
     
  2. ThoraflexTM Hybrid Ante-FloTM configuration facilitates the Island Technique

Product availability subject to local regulatory approval.

Delivery system designed for intuitive and accurate deployment2,3

Earlier patient re-warming, reduced myocardial ischaemia, lower body ischaemia and operating times1,3,4

One-stage operation for the patient1,2

ThoraflexTM Hybrid Product Animation

Key Features of ThoraflexTM Hybrid

One Stage Procedure

For the Frozen Elephant Trunk Technique

The Thoraflex™ Hybrid device allows a one stage procedure— it adds to the Frozen Elephant Trunk (FET) technique 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

  1. Compact design aids delivery system control3
  2. More* intuitive rapid release sheath splitter clip mechanism designed for enhanced deployment performance2
  3. More* conformable flexible shaft allowing easier shaping to suit patient anatomy and system trackability2
  4. Smaller 24 and 26mm distal stents enable a larger patient population to be treated2

* In comparison to earlier versions of ThoraflexTM Hybrid

Gelatin Sealed 

For safer anastomosis

The device is fully gelatin sealed and comprises a woven polyester proximal Gelweave™ Siena arch graft pre-sewn to a distal stent. This ensures easier and safer anastomosis of the prosthesis to the aorta reducing the haemodynamic traction on the anastomosis2

New and Expanded Range 

The new and expanded range of Thoraflex™ Hybrid includes both Plexus and Ante-Flo™ designs and smaller stent diameter sizes of 24 and 26mm4

  1. Choice of Plexus and Ante-FloTM designs for individual arch vessel reconstruction or the Island Technique1,2
  2. GelweaveTM Siena Collar ensures easier and safer anastomosis of the prosthesis to the aorta reducing the haemodynamic traction on the anastomosis 3
  3. New smaller 24 and 26mm stent options 
  4. Radiopaque markers simplify secondary procedures if needed 2
  5. Multiple independent ring stent design allows excellent anatomical conformability 6

Beneficial for the Patient

Thoraflex™ Hybrid used for the FET technique has been shown to allow earlier patient re-warming, reduced myocardial ischaemia, lower body ischaemia and operating times1-3

Implantation of the Thoraflex™ Hybrid device resulted in excellent outcomes and beneficial aortic remodelling during follow up6.

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

Professor Malakh Shrestha, Germany

Clinical Papers

Some of the clinical papers are listed below and are available on request

The Thoraflex™ Hybrid frozen elephant trunk device: The Bologna experience.

Di Marco L et al.

J Vasc Endovasc Surg, 2014; 21(3), 117-23

Multibranched hybrid device for frozen elephant trunk: what does it change?

Ruggieri VG et al.

Thoracic & Cardiovasc Surg, July 2015; 15(1), 253-255

Frozen elephant trunk with Thoraflex™ Hybrid prosthesis: early results of the prospective THORA-FET registry.

Maselli D et al.

AATS Aortic Symposium, May 2016, NY, USA

Clinical evaluation report for Thoraflex™ Hybrid device design dossier 019

Issue 4, Feb 2016

Total aortic arch replacement with a novel four-branched frozen elephant trunk graft: first-in-man results

Shrestha M et al.

European Journal of Cardio-Thoracic Surg, 2013;43, 406–410

Total aortic arch replacement with a novel 4-branched frozen elephant trunk prosthesis: single-centre results of the first 100 patients.

Shrestha M et al.

J Thoracic and Cardiovasc Surg, July 2016; 152(1), 148-159

Instructions for Use

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
  7. Di Bartolomeo R et al. The Bologna Experience with the ThoraflexTM 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. 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

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