• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Medical Devices

  • Print
  • Share
  • E-mail

Public Workshop - Cardiovascular Metallic Implants: Corrosion, Surface Characterization, and Nickel Leaching, March 8-9, 2012

The Food and Drug Administration (FDA) is announcing a public workshop on Cardiovascular Metallic Implants: Corrosion, Surface Characterization, and Nickel Leaching. The purpose of this workshop is to provide a forum for FDA, cardiovascular device manufacturers, test houses, and academia to discuss corrosion, surface characterization, and nickel leach testing, as well as collect comments and input regarding when these assessments may be considered.

Background and Objectives: While the majority of cardiovascular implants are made of metals and may be susceptible to corrosion, it is unclear whether the current corrosion testing paradigm is predictive of in vivo corrosion outcomes, or if there may be more suitable assessments to predict corrosion failure. In addition, there has been an increase in the use of nitinol, a nickel-titanium alloy, in cardiovascular implants due to its superelastic properties, which are ideal for transcatheter-delivered therapies. Corrosion of implant devices made of nitinol and other nickel-containing metal alloys (e.g. stainless steel, MP35N) results in the release of nickel ions, which may lead to various modes of toxicities. Furthermore, both nickel ion release and corrosion characteristics are dependent on surface finishing for nitinol as well as for some other nickel-containing alloys. Through the collection of information from a pre-workshop work assignment and discussions with workshop participants, FDA will be able to better determine what assessments may be considered for cardiovascular implants made of commonly used metallic alloys, and this information is expected to serve as the foundation for a future guidance document.

The objective of this workshop is to provide a forum for the discussion of:

  • the various methods that are used for corrosion assessments, surface characterization techniques, and nickel leach testing used to evaluate the suitability of metallic cardiovascular implant devices;
  • the limitations of each of these tests to predict actual in vivo performance;
  • the need and utility for each test; and
  • the potential testing paradigms, including when certain tests may be considered, and how to establish acceptance criteria for each test.

Workshop Participation: Participation in the workshop will consist of both lead discussants and audience members. Lead discussants will include representatives from various organizations involved in or who perform corrosion testing, surface characterization, and/or nickel leach testing and toxicological assessments of nickel, such as industry, the medical community, and test houses, and will be driving the discussions. Lead discussants are expected to complete a work assignment in advance of the meeting in order to optimize the time spent during the workshop. FDA will compile the work assignment responses prior to the workshop so that any information provided from the responding organization is de-identified.

Date, Time and Location

This meeting was held on March 8-9, 2012. The doors opened at 8:00 a.m. and the workshop began promptly at 9:00 a.m. at the following location:

FDA / White Oak Campus (building 31, great room)
10903 New Hampshire Avenue
Silver Spring, MD 20993

This workshop was also webcast.

Agenda (Preliminary)

Day 1 March 8, 2012  
9:00 – 9:15Welcoming Remarks Erica Takai (Office of Science and Engineering Laboratories)
9:15 – 11:30Session #1: Corrosion  
11:30 – 13:00Lunch on your own
13:00 – 15:00Session #1: Corrosion (cont.)
15:00 – 17:00Session #2: Surface Characterization of Nickel-Containing Alloys
Day 2 March 9, 2012  
9:00 – 12:00Session #3: Nickel Leach and Toxicity  
12:00 – 13:30Lunch on your own
13:30 – 14:00Session #3: Nickel Leach and Toxicity (cont.)  
14:00 – 17:00Session #4: Summary and Potential Testing Paradigms

Objectives

Contacts

For questions regarding workshop content please contact:

Erica Takai, Ph.D.
Inter-Office Liaison
Office of Science and Engineering Laboratories
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
Phone: (301) 796-6353
Fax: (301) 796-9959
e-mail: erica.takai@fda.hhs.gov

Nicole Ibrahim, Ph.D.
Scientific Reviewer
Division of Cardiovascular Devices
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
Phone: (301) 796-6171
Fax: (301)-847-8119
e-mail: nicole.ibrahim@fda.hhs.gov