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U.S. Department of Health and Human Services

Medical Devices

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Two-day Tissue Adhesives / Soft Tissue Workshop / Symposium, September 26-27, 2011

The Food and Drug Administration (FDA) is announcing a Workshop to facilitate medical device innovation with the focus on tissue adhesive materials. In the last 20 years there has been an explosion in the number of biomaterials being used as adhesives. There is incredible variation in the indications, adhesion mechanisms and formulation of these adhesives. To date, such adhesives have only been approved for use on the skin and some other limited anatomic sites but are being proposed for use as an adhesive in many internal anatomic locations. Since the FDA first approved a single synthetic cyanoacrylate tissue adhesive for topical wound closure, in 1998, an extended family of chemical tissue adhesives has emerged. This new family is comprised of fibrin-based adhesives, synthetic and protein polymers, and cements –- all of which extend application beyond wound closure to indications such as hemostasis and bone bonding. Many of these emerging tissue adhesives could modify difficult surgical procedures by stabilizing tissue surfaces through hemostasis, sealing of wounds, and fixation of tissue in areas inaccessible to staples, clips, and suture placement.

The purpose of the workshop/symposium is to understand these adhesives in terms of mechanism; toxicity and potential indications will guide innovation and help guide appropriate regulatory pathways to develop new tissue adhesive biomaterials that can be used clinically for external and/or internal applications. Discussions regarding the use of presently used and experimental tissue adhesive in animal studies and in recently reported clinical studies will provide insights into the design of future biodegradable or bioabsorbable tissue adhesives that may have potential to be used in humans for clinical applications. It is important to ensure existing products are used properly and new tissue adhesive biomaterials are developed properly for new intended uses and that new products can be efficiently developed more likely to result in safe products that benefit patients and consumers when implemented for clinical use.


Date, Time and Location

This Two-day Tissue Adhesives/Soft Tissue Workshop/Symposium will be held on September 26 and September 27, 2011 beginning 8:00 a.m. at the FDA White Oak Campus, Building 2, A-2031, 10903 New Hampshire Avenue, Silver Spring, Maryland 20993.

The meeting will be available via webcast.

Webcast

Agenda

Day One

TimeTopicSpeaker(s)
8:30 a.m-8: 40 a.m.Welcome and Introductory RemarksWilliam Maisel, MD, MPH
Deputy Director for Science, FDA/CDRH
8:40 a.m-8: 55 a.m.Keynote Address: FDA’s Role in Medical Device Innovation with the Focus on Tissue Adhesive MaterialsChristy L. Foreman, MS
Director, Office of Device Evaluation (ODE)/CDRH
8:55 a.m-9: 05 a.m.Introduction to Workshop/Symposium and Introduction of Clinical/Scientific Expert SpeakersModerators:
George Mattamal, PhD
General Surgery Device Branch, DSORD/ODE
James Quinn, MD, MS
Professor of Surgery
Stanford University
David Krause, PhD
Chief, Plastic and Reconstructive Device Branch, DSORD/ODE
9 :05 – 9:35 a.m.Clinical Overview, Historical Perspective and Future Direction of Tissue Adhesives, Sealants, and “Glues”James Quinn, MD, MS
Professor of Surgery
Research Director for
Emergency Medicine
Stanford University
Palo Alto, California
9 :35 a.m-10: 05 a.m.Introduction to Adhesion Principles – Implications for Biomaterials –Kashmiri Lal Mittal, PhD
Editor-in- Chief.
Journal of Adhesion Science and Technology
10:05 a.m-10: 30 a.m.
Coffee/Break
 
10:30 a.m-11:00 a.m.Cyanoacrylate Tissue Adhesives for Wound Closure in the Emergency DepartmentJudd E. Hollander, MD
Professor of Surgery, Clinical Research Director
Department of Emergency Medicine, University of Pennsylvania
11:00 a.m-11: 30 a.m.Use of Adhesive in Facial Plastic SurgeryDean M. Toriumi, MD
Professor of Surgery
Division of Facial Plastic and Reconstructive Surgery, Department of Otolaryngology – Head & Neck Surgery
University of Illinois at Chicago
11:30 a.m-12:00 p.m.Use of Topical Skin Adhesives for Non-Incisional Wounds: Preclinical and Clinical ExperienceAdam J. Singer, MD
Professor of Surgery
Vice Chairman for research, Department of Emergency Medicine
Stony Brook University and Medical Center
12:00 p.m. -1:00 p.m.
Lunch
 
1:00 p.m. - 3:00 p.m.Industry Abstracts for Topical Uses (15 minutes each). 
3:00 p.m. - 3:30 p.m.
Coffee/Break
 
3:30 p.m. - 4:30 p.m.Panel Discussion 1
Topical Use of Adhesives –
  • Where we have been, where we are going?
  • Focus on guidance documents and Reclassification of tissue adhesive products
  • Pre-clinical/ Clinical approach to new polymers and products
  • Kits containing cleared/approved tissue adhesive products
Moderators:
James Quinn, MD, MS, Stanford University
David Krause, PhD,
Chief, Plastic and Reconstructive Device Branch, DSORD/ODE
               And
    † Panelists:
  • George Mattamal, PhD, DSORD/ODE
  • Anthony Watson, BS, MS, MBA,
            Director, DAGID/ODE
  • Erin Keith, MS, Deputy Director for Science and Policy, DSORD/ODE
  • Charles Durfor, PhD, DSORD/ODE
  • Roxolana Horbowyj, MD, MS, DSORD/ODE
  • Peter Hudson, PhD, DSORD/ODE
  • Joseph Nielsen, PhD, DSORD/ODE
  • Kelley Burridge, PhD, DSORD/ODE

† Speakers will be on the panel
4:30 p.m-4:40 p.m.
 
Wrap-Up and Adjourn

Peter Rumm, MD, MPH, Deputy Director of Clinical, DSORD/ODE

DAY TWO
  
8:30 a.m-8:40 a.m.FDA Welcome and Opening RemarksMarkham C. Luke MD, PhD, Deputy Director of Clinical, ODE/FDA
8:40 a.m.- 9:10 a.m.FDA Regulatory History of Tissue Adhesives, Sealants, and GluesDavid Krause, PhD
Chief, Plastic and Reconstructive Device Branch, DSORD/ODE
9:10 am-9:40 a.m.Sealants Regulated by the Center for Biologics Evaluation and Research (CBER)Nisha Jain, M.D,
Chief, Clinical Review Branch, Division of Hematology, OBRR/CBER
9:40 am-10:10 p.m.The Use of Hemostats, Sealants, and Adhesives in Vascular SurgeryWilliam D. Spotnitz, MD, MBA, FACS
Professor of Surgery,
Director of Surgical Therapeutic Advancement Center, University of Virginia Health System
               &
Sandra G. Burks, RN, BSN, CCRC
Associate Director of the Surgical Therapeutic Advancement Center
Department of Surgery
University of Virginia Health System
10:10-10:30 am.
Coffee/Break
 
10:30 a.m. 11:00 am.Synthetic and Proteinaceous Hydrogel Polymer Adhesives and Their Various Clinical UsesK. Ümit Yüksel, PhD
Senior Director, Medical Adhesives, Sealants & Hemostats, CryoLife, Inc.
11:00 a.m.– 11:30 a.mAdhesives Used as Liquid Embolic AgentsCharles W. Kerber, MD,              
Clinical Professor
Department of Radiology
University of California
San Diego, CA
11:30 a.m.- 12:00 pmThe Use of Hemostats, Sealants, and Adhesives in Lung SurgeryWilliam D. Spotnitz, MD, MBA, FACS
Professor of Surgery,
Director of Surgical Therapeutic Advancement Center , University of Virginia Health System
                    &
Sandra G. Burks, RN, BSN, CCRC
Associate Director of the Surgical Therapeutic Advancement Center
Department of Surgery
University of Virginia Health System
12:00 – 1:00 p.m.
          
Lunch
 
1:00p.m.- 2:30 p.m.Industry Abstracts (15 minutes) 
2:30 p.m. – 3:00 p.m.
Coffee Break
 
3:00 p.m-4:00 p.m.Panel Discussion 2
-Pre-clinical/Clinical approach to Implantable Adhesives
-Developing Guidance documents for
Implantable Adhesives
- Manufacturing Controls
Moderators:
James Quinn MD, MS, Stanford University
David Krause, PhD,
Chief, Plastic and Reconstructive Device Branch, DSORD/ODE
               And
     †Panelists:
  • George Mattamal, PhD, DSORD/ODE
  • Peter Rumm, MD, MPH, Deputy Director of Clinical, DSORD/ODE
  • Jennifer Goode, BS,
            DCD/ODE
  • Peter Hudson, PhD, DSORD/ODE
  • Stephen Curtis, DVM, DSORD/ODE
  • Roxolana Horbowyj, MD, MS, DSORD/ODE
  • Charles Durfor, PhD, DSORD/ODE
  • Joseph Nielsen, PhD, DSORD/ODE
  • Kelley Burridge, PhD,DSORD/ODE
  • Danish V. Patwardhan, Ph.D., Director, DCMS/OSEL
  • Katherine Vorvolakos, Ph.D., DCMS/OSEL
† Speakers will be on the panel
4:00 p.m– 4:15 p.m.
Wrap-Up & Symposium/ Workshop Closing remarks
Mark Melkerson, MS,
Director, DSORD/ODE
                &
George Mattamal, PhD
James Quinn, MD, MS
David Krause, PhD
4:30 p.m. - Adjourn  

Registration to Attend the Workshop

Registration is closed as of September 21, 2011.

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.

If you need special accommodations due to a disability, or additional information regarding registration, please contact Alexander Cox, Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 66, Silver Spring, MD 20993, 301-796-9696, Alexander.cox@fda.hhs.gov.

Contact Us

George Mattamal, Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 66, Silver Spring, MD 20993, 301-796-6396, george.mattamal@fda.hhs.gov.