Thoraflex™ Hybrid
Conforming Aortic Arch Surgery to the Gold Standard
Our Hybrid solutions are a harmonious combination of woven surgical grafts and stent grafts that enable you to address your patient’s aorta.
Gold Standard, Surgical Confidence
Deliver proven outcomes when treating your patient’s complex aortic arch pathology, utilising our innovative Hybrid Solutions.
10+ Years of Clinical Data
Polyester Graft
- Gelatin sealed (hydrolysis <14 days)
- Effective & easy suturing 1
- Easy to handle 1
- Gelatin bonds with Rifampicin 2
- Gelatin: lower thrombogenic potential 3 (than unsealed polyester grafts)
- High resistance to dilation at 2 years 4
Supra-Aortic Branches
- Plexus design
- Replacement of dissected vessel
- 12/8/10mm or 10/8/8mm
Antegrade Perfusion Branch
- Facilitates organ perfusion and rewarming 6
Pre-Attached Collar
- Easier/safer Anastomosis 6
- Reduced Haemodynamic traction 6
Tantalum Radiopaque Markers
- Stent: Endovascular extension markers (20mm increments)
- Graft: 2x branch markers
Independent Ring-Stent Design
- Anatomic Conformability 7
- Minimises risk of intimal injury 7
- Induces downstream remodelling 8
- Structural support for Gelatin
- Sealed endovascular fabric
Thoraflex Hybrid Plexus
Supra-Aortic Branches
- Plexus design
- Replacement of dissected vessel
- 12/8/10mm or 10/8/8mm
Antegrade Perfusion Branch
- Facilitates organ perfusion and rewarming 6
Pre-Attached Collar
- Easier/safer Anastomosis 6
- Reduced Haemodynamic traction 6
Tantalum Radiopaque Markers
- Stent: Endovascular extension markers (20mm increments)
- Graft: 2x branch markers
Independent Ring-Stent Design
- Anatomic Conformability 7
- Minimises risk of intimal injury 7
- Induces downstream remodelling 8
- Structural support for Gelatin
- Sealed endovascular fabric
Thoraflex Hybrid Ante-Flo
100% Gelatin Sealed Gelweave™ surgical graft and polyester stent graft
Versatility in Treatment
Plexus and Ante-Flo™ designs enable a choice of surgical techniques and widen the treatable patient population.
Offering Plexus & Ante-Flo™ Configurations
- Thoraflex Hybrid Plexus configuration facilitates individual arch vessel reconstruction 9
- Thoraflex Hybrid Ante-Flo™ configuration facilitates the island technique 10
Thoraflex Hybrid is designed for the open surgical repair of aneurysms and/or dissections in the aortic arch and descending aorta with or without involvement of the ascending aorta.
Flexible & Compact Delivery System
Intuitive design with enhanced deployment performance for accurate positioning.
Release Wire Clip
- Designed to detach graft from delivery system
Handle
- Control during deployment
- Visualisation of operating field
Strap Handle
Attached to sheath
Pull to start graft
deployment
Sheath Splitter
Atraumatic blades (top/bottom)
Rapid release suture system
PTFE Sheath (30F)
Peelable/Splittable Sheath
Split-Lines to facilitate
deployment
Malleable Shaft
Adaptable to patient anatomy
Can be reshaped
Atraumatic Tip
30F diameter (10mm)
(2x) 0.035" Guidewire Access Ports
- Delivery system introduction
- Accurate placement of stent
Thanks to the malleable shaft, the stented part can be shaped to conform to the isthmus and descending aorta anatomy. This makes the device less traumatic on the descending aortic wall and easier to introduce into the aorta...6
Thinking Ahead with Relay®Pro
The only FDA approved endovascular device indicated for extending Thoraflex™ Hybrid
With up to 33% FET repairs needing a future downstream intervention,13 utilising RelayPro in conjunction with Thoraflex Hybrid is indicated for on-label distal endovascular repair.
RelayPro offers the ideal endovascular solution to treat FET patients with more extensive disease, by virtue of:
- NBS (non-bare stent) configuration
- Low profile delivery system
Downstream TEVAR following the FET procedure is associated with excellent clinical outcomes. We thus maintain that staging thoracic aortic repair - FET and secondary TEVAR - is a very successful and safe strategy... 14
Use of Relay®Pro subject to local regulatory approval.
CT Image courtesy of Marco Di Eusanio; Lancisi Cardiovascular Center Ancona, Italy
Clinical Data
30 day mortality rate 5
Acute Thoracic Aortic Syndrome
(5/62 Patients)
30 day mortality rate 5
9/181 Patients
False lumen thrombosis 11
(within 2 years)
at the level of the stent graft
Single-stage operation potential for the patient 12
Downloads
Features & Benefits
Thoraflex Hybrid
Discover how each of the key features and benefits are integrated into our surgical portfolio to ensure the highest quality and performance possible.
References
*FET= Frozen Elephant Trunk
Adachi et al. (1996) ‘Clinical Experience of a New Gelatin Impregnated Woven Dacron Graft.’ Japan Journal of Artificial Organs, 25 (1), pp214-219.
Gahtan et al. (1995) ‘Antistaphylococcal Activity of Rifampicin-Bonded Gelatin-Impregnated Dacron Grafts.’ Journal of Surgical Research, 58, pp105-110.
Drury et al. (1987) ‘Experimental and Clinical Experience with a Gelatin Impregnated Dacron Prosthesis.’ Annals of Vascular Surgery, 1, pp542-547.
Mattens et al. (1999) ‘Gelseal® Versus Gelweave® Dacron Prosthetic Grafts in the Descending Thoracic Aorta: A Two-Year Computed Tomography Scan Follow-Up Study.’ Cardiovascular Surgery, 7 (4), pp432- 435
Results from Thoraflex Hybrid Post-Market Study (THOR) – NCT03414866 (unpublished).
Ruggieri et al. (2015) ‘Multibranched hybrid device for frozen elephant trunk: what does it change?’ Journal of Thoracic & Cardiovascular Surgery, 15 (1), 253-255.
Ma et al. (2015) ‘Open Stented Grafts for Frozen Elephant Trunk Technique: Technical Aspects and Current Outcomes.’ AORTA, 3 (4), pp122-135.
Berger et al. (2018) ‘True-lumen and false-lumen diameter changes in the downstream aorta after frozen elephant trunk implantation.’ European Journal of Cardiothoracic Surgery, 54, pp375–381.
Di Marco et al. (2017) ‘The frozen elephant trunk technique: European Association for Cardio-Thoracic Surgery Position and Bologna experience.’ Korean Journal Thoracic & Cardiovascular Surgery, 50, pp1-7.
Coselli et al. (2024) ‘Total aortic arch replacement using a frozen elephant trunk device: Results of a 1-year US multicenter trial’, The Journal of Thoracic and Cardiovascular Surgery – Adult Aorta, 167 (5) pp1-12.
Shrestha et al. (2016) ‘Total aortic arch replacement with a novel 4-branched frozen elephant trunk prosthesis: single-centre results of the first 100 patients.’ Journal of Thoracic & Cardiovascular Surgery, 152 (1), pp148-159.
Mariscalco et al .(2019), “Reflection from UK Aortic Group: Frozen Elephant Trunk Technique as Optimal Solution in Type A Acute Aortic Dissection.” Seminars in Thoracic Surgery 31, pp686–690.
Kreibich et al. (2020) ‘Aortic reinterventions after the frozen elephant trunk procedure.’ The Journal of Thoracic and Cardiovascular Surgery, 159 (2), pp392-399.
Kreibich et al. (2022) ‘Downstream thoracic endovascular aortic repair following zone 2, 100mm stent graft frozen elephant trunk implantation.’ Interactive CardioVascular and Thoracic Surgery, 34 (6), pp1141-1146.
Product Disclaimer
Product availability subject to regulatory approval.
An EU Declaration of Conformity may be requested from regulatoryaffairsuk@terumoaortic.com
Instructions for Use
View the eIFU for more information on use, indications, contraindications, warnings/precautions and availability within your market.
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