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.

If you wish to participate as a lead discussant, you must indicate this at the time of registration. There will be a tentative limit of 1 lead discussant per organization for industry participants and 3 for test houses for each session, with a total workshop participation limit of 2 industry participants and 4 for test houses, due to space limitations.

• Date, Time and Location
• Federal Register Notice
• Agenda
• Objectives
• Meeting Transcripts
  • Day 1
  • Day 2
• Registration
• Contact Us

Date, Time and Location

This meeting will be held on March 8-9, 2012. The doors will open at 8:00 a.m. and the workshop will begin 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

• FDA Campus Information

This workshop will also be webcast. Persons interested in viewing the webcast must have registered online by 5 p.m. by February 21, 2012. Early registration is recommended because webcast connections are limited. Organizations are requested to register all participants, but view using one connection per location. Webcast participants will be sent technical system requirements after registration, and will be sent connection access information after February 21, 2012. If you have never attended a Connect Pro event before, test your connection. To get a quick overview of the Connect Pro program, visit Connect Pro Overview. (FDA has verified the Web site addresses in this document, but FDA is not responsible for any subsequent changes to the Web sites.)

Agenda (Preliminary)

Objectives

• Workshop Objectives

Registration to Attend the Workshop

As of Friday February 24, online registration is now closed. There will be on-site registration only for audience participation.

There is no fee to register for the Workshop and registration will be on a first-come, first-served basis. Early registration is recommended because seating is limited.

Participation in the workshop will consist of both lead discussant and audience members. Invited participants include representatives from various areas involved in/perform corrosion, 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 discussant 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 so that any information provided is de-identified from the responding organization.

If you wish to participate as an lead discussant, you must have indicated this at the time of registration. There will be a tentative limit of 1 lead discussant per organization for industry participants and 3 for test houses for each session, with a total workshop participation limit of 2 industry participants and 4 for test houses, due to space limitations.

Contacts

If you need special accommodations due to a disability, or additional information regarding registration, please contact Susan Monahan, Food and Drug Administration, 10903 New Hampshire Avenue, WO66 – Room 4321, Silver Spring, MD, 20993, phone: 301-796-5661 or e-mail: susan.monahan@fda.hhs.gov.

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