Thoraflex™ Hybrid
Conforming 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
Jeff was treated with our Thoraflex Hybrid graft and Gelweave products, after suffering form an Acute Type A dissection. He has since recovered from the procedure.