CORROSION BEHAVIOR OF NITINOL VASCULAR DEVICES

Alan R. PeltonRiepe, et al. SMST 2000

Corrosion and Biocompatibility Depend on Surface Processing

7 September 2017 Greenberg Stent Summit

Jetty, et al. J Vasc Surg 2013

2

FDA Stent Guidance Document 2015

7 September 2017 Greenberg Stent Summit 3

Anodic Polarization Corrosion Resistance: Passivated and Thermal Oxide Surface

7 September 2017 Greenberg Stent Summit

ASTM F2129, PBS, 37˚C

Pelton and Blaich SurFACTS in Biomaterials 2017

4

7 September 2017 Cleveland Clinic Stent Summit

Thermal Oxide: Greater Ni-ion Release From Devices

PBS Solution, 37˚CConsistent with ISO 10993-15

Acute Ni intoxication in dialyzed patients Ni ~ 3 ppm (Webster, et al. 1980)

Ni cytotox response at > 6 ppm (Messer, et al. 2005); 9 ppm (Shih, et al. 2000)

Ni release rate in blood should not exceed 35 μg/day (Sunderman, 1983)

Ni-Ion Release After Crush Fatigue

Pelton and Blaich SurFACTS in Biomaterials 2017

6

7 September 2017 Greenberg Stent Summit

OT Inflammation

MP

SPA

F

Inflammation

in vitro and Six-Month Animal Investigation

Stacey J.L. Sullivan1

Daniel Madamba2

Shiril Sivan1

Katie Miyashiro2

Maureen L. Dreher1

Christine Trépanier2

Srinidhi Nagaraja1

Sullivan et al., Acta Biomaterialia https://doi.org/10.1016/j.actbio.2017.08.029

Nagaraja et al., SMST 2017

Ni release is not correlated to pitting potentials from ASTM F2129

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Needle Selection for Graft Suturing Affects Corrosion

7 September 2017 Greenberg Stent Summit 8

Corrosion and Biocompatibility of Nitinol

7 September 2017 Greenberg Stent Summit

Imperative to remove Ni + Ni3Ti + TiO2 after thermal processing

Create Ni-free amorphous Ti-O surface for passivation

2015 FDA Guidelines necessary but not sufficient to predict chronic corrosion behavior

Recommend dynamic corrosion and Ni-ion release testing for vascular devices

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SMST 2017 San Diego, CA 17 May 2017 Slide

Thank You!

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