Overview of available flow diverters

SVIN 2014 meeting Hollywood, FL

November 8, 2014

• Flow diverter concept and design

•Basic definitions

•Mechanism of action

•Potential advantages and disadvantages

•Current devices and evidence

•Conclusions

Concept, design

•Paradigm shift

• Flow diverter concept and design

•Basic definitions

•Mechanism of action

•Potential advantages and disadvantages

•Current devices and evidence

•Conclusions

Basic definitions and considerations

•Porosity

•Metal surface coverage

•Pore density

Source: PatentUS 7763011

Basic definitions

•Free stent segment

•Transition zone

• Flow diverter concept and design

•Basic definitions

•Mechanism of action

•Potential advantages and disadvantages

•Current devices and evidence

•Conclusions

Mechanism of action

Considerations

• Effect on FD effect and aneurysm thrombosis

• Flow diverter concept and design

•Basic definitions

•Mechanism of action

•Potential advantages and disadvantages

•Current devices and evidence

•Conclusions

Potential advantages

Potential disadvantages/complications

Potential disadvantages/complications

• Flow diverter concept and design

•Basic definitions

•Mechanism of action

•Potential advantages and disadvantages

•Current devices and evidence

•Conclusions

Devices

•Pipeline

•Surpass

•Silk

•FRED

Device Source: Covidien

Device

PITA: Neck > 4mm, dome/neck > 1.5, failed prior tx, 4 PCA, 2 verts, 1 MCA. No deaths (Nelson PK et al. AJNR 2011)

PED Buenos Aires: 4 vertebral, 1 PICA, 1 VBJ, 2 basilar (Lylyk P et al. Neurosurgery 2009)

PED Budapest: 1 basilar trunk aneurysm (Szikora I et al. AJNR 2010)

Source: www.ev3.net

18.2 mm

• Primary endpoint73.6%

86.8 %

5.6% 1.9%

2.8%

• Rapidly fatal, possibly neurologic event (fall/ICH): 0.9%

• Amaurosis fugax 4.7%, visual field worsening 0.9%

8.4%

3.8%

0.6% 2.4%

4.7%

Device

Studies

up to 5% mortality 15% morbidity

• Complete occlusion 68-87%

81.8% (of 264 aneurysms on f/u)

10% 10%

4.9%

3.5%

Device

Data

morbidity: 6%,

mortality: 2.7%

3.7%

2.5%; 2.5%

• 75%

Data

Devices

Studies

Brinjikji W et al.Stroke 2013

Overall morbidity, complications and delayed problems:

2-6%

Brinjikji W et al.Stroke 2013

v

v

*

*

Complete aneurysm occlusion

at 6 months:

76%

• Increased risk: fusiform, symptomatic, long, basilar

Trial Comparison

FIAT FD versus coil, stent, vessel sacrifice, surgery

PREMIER Pipeline for aneurysms < 12 mm

SCENT Surpass for aneurysms > 10 mm

FRED FRED FD device

MARCO POLO Silk vs coiling +/- stenting

LARGE Aneurysms > 10 mm, FD vs coiling

EVIDENCE Aneurysms > 7 mm, Pipeline vs coiling +/- stenting

COCOA Pipeline vs coiling

ISAT 2 Endovascular incl. FD vs surgery

68% Silk, 88% Pipeline

Our PC FD experience

12.5% (1 case, 18 mo p procedure)

• Complete occlusion: 62.5% (mean f/u 13.1 mo)

Basilar fenestration aneurysm

Fusiform basilar aneurysm

Left P1 recurrent dysplastic aneurysm

Considerations and therapeutic challenges