Corporate Support:

This one-and-a-half-day symposium will include the most up-to-date information in the field of tissue sealants and adhesives. The meeting will provide a forum in which researchers doing work with a variety of materials including fibrin sealant, collagen and thrombin, cyanoacrylates, polyethylene glycol polymers, and cross-linked albumin, as well as other innovative new materials, will have the opportunity to learn about why surgeons choose a particular sealant and to hear about the changing usage patterns for these products from institutions tracking these trends. Discussion will focus on safety issues in the use of sealants and adhesives. Delegates will have the opportunity to interface with national and international regulatory agencies and learn what they can do to better facilitate communications with these groups. Information will be shared on how to best design clinical trials and effective preclinical assays.

The Second Annual Guenther Schlag Tissue Sealant Award
will be presented for the most innovative abstract by a student or fellow at the meeting.

Immediately preceding The American College of Surgeons Clinical Congress

Sponsoring Association:
American Professional Wound Care Association

Sponsoring Society:
TESI

Sponsoring Publications:
MedMarket Diligence
IBPN

SCIENTIFIC ADVISORS
Ms. Sandra Burks, University of Virginia
Dr. Martin MacPhee, Clearant, Inc.
Dr. Heinz Redl, Ludwig Boltzmann Institute for Experimental & Clinical Traumatology
Dr. William D. Spotnitz, University of Florida
Dr. Dean Toriumi, University of Illinois at Chicago
Dr. Christopher Woolverton, Kent State University

CONFERENCE CHAIRPERSON
Dr. Martin MacPhee, Clearant, Inc.

ADDITIONAL SPEAKERS AND CHAIRPERSONS
Dr. Ian Cottingham, PPL Therapeutics Ltd. (UK)
Dr. John Hess, University of Maryland-Baltimore
Dr. H. K. Kjaergard, Gentofte Hospital (Denmark)
Dr. Gerard Marx, Hapto Biotech Ltd. (Israel)
Dr. James W. Polarek, FibroGen, Inc.
Dr. Daniel P. Polidoro, Baxter Bioscience - Fremont
Dr. Colin McKee, PPL Therapeutics Ltd. (UK)
Dr. Worthington G. Schenk, III, University of Virginia
Dr. Richard W. Storrs, Plasmaseal
Dr. Félix Vega, Baxter Bioscience - Fremont
Dr. David Velasquez, 3M Medical Division
Dr. John Vournakis, Marine Polymer Technologies, Inc.
Dr. Ümit Yüksel, CryoLife Inc.

ISSUES IN THE FIELD
How Surgeons Make the Tissue Sealant Decision
Changing Patterns of Tissue Adhesive Use in the OR and Beyond
Effective Use of Tissue Sealants in Surgery
Interfacing with US and European Regulatory Agencies
The Case for the Development of in Vitro and in Vivo Standards for Tissue Adhesives

PRESENTATION OF THE SECOND ANNUAL GUNTHER SCHLAG TISSUE SEALANT AND ADHESIVE AWARD
Oral presentation of the winning Schlag abstract

NEW AND EMERGING PRODUCTS AND USES
Hematological View of Sealants and Adhesives
Cell-Loaded Fibrin Microbeads (FMB) as "Liquid Tissue" for Tissue Engineering
Plasmaseal
FibRx®, a Single-Vial Fibrin Sealant
Surgical Sealant for Pulmonary Use
Pilot Study to Evaluate a Poly-N-acetyl Glucosamine Material to Aid in Endoscopic Mucosal Resection
Recombinant Human Collagens for Tissue Hemostat, Sealant, and Adhesive Applications
Fibrin I, a New Single-Component Fibrin Sealant

APPLICATIONS WITH APPROVED PRODUCTS
Brain Implantation Study in Rats to Evaluate the Safety, Biocompatibility, and Biodegradation of FloSeal® Matrix Hemostatic Sealant
Vivostat® Patient-Derived Fibrin Sealant is a More Rapidly Effective Hemostat than Oxidized Cellulose (Surgicel®) in Cardiothoracic Surgery
Rabbit Carotid Artery Anastomosis Study
Fibrin Sealant Improves Hemostasis in Polytetrafluoroethylene Grafts
Hemostatic Sealant for Urological Applications
Going Forward

 

SATURDAY, OCTOBER 5

11:30am Registration, Poster and Exhibit Setup

 

ISSUES IN THE FIELD

1:00 Welcome and Opening Remarks
Dr. Martin MacPhee, Clearant, Inc.

1:10 Session Overview
Dr. John Hess, Associate Director, Blood Bank, University of Maryland-Baltimore

1:15 How Surgeons Make the Tissue Sealant Decision
Dr. William D. Spotnitz, Chairman of the Division of Thoracic and Cardiovascular Surgery, University of Florida
At least five families of tissue adhesive and hemostatic products now exist. The relative benefits and optimal uses as well as safety profiles for these materials will be presented. Specific clinical procedures will be highlighted and the decision making process for choosing the optimal agent will be outlined.

2:00 Changing Patterns of Tissue Adhesive Use in the OR and Beyond
Ms. Sandra Burks, Surgical Therapeutic Advancement Center, University of Virginia
With the introduction of multiple agents, practice patterns of surgical adhesive use are evolving as clinicians familiarize themselves with the capabilities of each product. Specific examples of new patterns and the etiologies for these innovative uses will be presented and discussed.

2:30 Effective Use of Tissue Sealants in Surgery
Dr. Dean Toriumi, Associate Professor, Facial, Plastic and Reconstructive Surgery, University of Illinois at Chicago
This presentation will cover critical issues related to the successful use of tissue sealants such as the importance of the preparation of the surgical site, significance of applicators, and use of proper thrombin concentrations. The use cyanoacrylates and the importance of proper patient selection, use of subcutaneous sutures, and skin edge eversion will also be discussed. Finally, it will cover important endpoints and some design elements for clinical studies.

3:15 Poster and Exhibit Viewing, Refreshment Break

3:45 Interfacing with US and European Regulatory Agencies
This presentation will discuss important updates and issues related to interfacing with the FDA and European regulatory agencies on the topics surrounding tissue sealant and adhesive licensure.

Submission of Applications for Products Intended as Adjuncts to Hemostasis
Dr. Andrew Chang, Special Assistant to the Director, Hematology CBER, FDA

 

4:30 The Case for the Development of in Vitro and in Vivo Standards for Tissue Adhesives
Dr. Heinz Redl, Associate Professor, Ludwig Boltzmann Institute for Experimental & Clinical Traumatology

4:45 Presentation of the Second Annual Gunther Schlag Tissue Sealant and Adhesive Award
Dr. Heinz Redl

5:00 Oral Presentation of the Winning Schlag Abstract

5:15 Panel Discussion with All Afternoon Speakers

5:30-6:30 Networking Reception

 

SUNDAY, OCTOBER 6

7:00am Poster and Exhibit Viewing, Light Continental Breakfast

 

NEW AND EMERGING PRODUCTS AND USES

7:30 Comments by Session Chairpersons
Dr. Heinz Redl
Dr. Christopher Woolverton, Associate, Kent State University

7:45 Hematological View of Sealants and Adhesives
Dr. John Hess
A thorough understanding of the hematological scheme of events involved in clotting and hemostasis is critical to the successful development of a tissue sealant or adhesive. This presentation will focus on helping researchers more fully appreciate the implications of these events in the successful application of these products and devices.
8:15 Cell-Loaded Fibrin Microbeads (FMB) as "Liquid Tissue" for Tissue Engineering
Dr. Gerard Marx, Hapto Biotech Ltd.
Fibrin-microbeads (FMB) were fabricated from fibrinogen and thrombin, under heated, oil-emulsion conditions. We used FMB to isolate pluripotent mesenchymal (stem) cells from mouse bone marrow, then drove their differentiation into osteoblasts. After implantation into the mouse kidney, ectopic bone was formed. Thus, FMB may provide a method for isolating and growing autologous stem cells. The delivery of cells-on-FMB (suspended in fibrinogen as "liquid tissue") could be performed with dual channel, fibrin glue pistols.

8:45 Plasmaseal
Dr. Richard Storrs, Vice President, Research, Plasmaseal
Platelet-plasma concentrate can be prepared intra-operatively from whole patient blood in minutes. Platelet-plasma concentrate contains concentrated autologous plasma proteins including fibrinogen and fibronectin as well as concentrated platelet growth factors. It can be used for both hemostasis and tissue healing. PlasmaSeal has developed blood processing devices for several different surgical situations, and has a patent monopoly on plasma concentration.

9:15 FibRx®, a Single-Vial Fibrin Sealant
Dr. Ümit Yüksel, Director, BioGlue Technologies, CryoLife Inc.
FibRx is a single-vial, hemostatic formulation, containing virally inactivated human fibrinogen and inhibited-human thrombin. FibRx utilizes a light reversible serine protease inhibitor (AZ-nu) that is activated with visible light to rapidly generate thrombin, which cleaves fibrinogen to form a clot. FibRx is stable for > 8 hours, its clotting rate can be controlled by light intensity, and it can be delivered via spray, syringe, or endoscopic instruments without clotting in the delivery device.

9:45 Poster and Exhibit Viewing, Refreshment Break

10:15 Surgical Sealant for Pulmonary Use
Dr. David Velasquez, Research Scientist, 3M Medical Division
3M has developed an easy-to-use surgical sealant targeted for sealing pulmonary air leaks. The sealant chemistry, applicator, preparation method, and application methods will be described. The performance of the sealant in a variety of test methods and systems will also be discussed. (Coauthors: Kristen Comstock, Karen Holmen, Tim Kappers, and Pat Parks)

10:45 A Pilot Study to Evaluate a Poly-N-acetyl Glucosamine Material to Aid in Endoscopic Mucosal Resection (EMR)
Dr. John Vournakis, Marine Polymer Technologies, Inc.
The aim of this study was twofold: (1) to compare the quality and duration of the submucosal cushion produced by pGlcNAc to that produced by saline and (2) to determine the short-term (bleeding and perforation) and long-term (stricture) complications of performing widespread EMR using this material.

11:15 Recombinant Human Collagens for Tissue Hemostat, Sealant, and Adhesive Applications
Dr. James W. Polarek, Vice President, FibroGen, Inc.
The fundamental role of the collagen family of proteins in wound healing and hemostasis has made them common components in many tissue hemostat, sealant, and adhesive formulations. The use of collagen in these formulations has been limited predominately to Type I collagen and denatured derivatives (gelatin) that can be isolated from various animal tissues. The application of recombinant protein technology now provides a new source of several collagen family members in safe and stable formats. This presentation will highlight the structural and functional properties of recombinant human collagens and outline their potential utility in the next generation of tissue hemostat, sealant, and adhesive formulations. (Coauthors: Juliana Balan, Patrick Hillas, James Polarek, James Tang, and Chunlin Yang)

11:45 Fibrin I, a New Single-Component Fibrin Sealant
Dr. Ian Cottingham and Dr. Colin McKee, PPL Therapeutics Ltd.
In a pig liver model for evaluating hemostasis evaluation Fibrin I has been shown to be a highly effective hemostat. It promotes rapid natural wound healing with a minimal inflammatory response-even using human Fibrin I in the pig. It is also effective in the prevention of post-surgical adhesions as demonstrated in the rabbit uterine horn model. Fibrin I can also be used as a vehicle for the delivery and maintenance of viable fibroblasts, or other cells, to a wound site, thereby providing the opportunity for advanced wound care applications.

12:15 Panel Discussion with All Morning Speakers

12:30 Luncheon

 

APPLICATIONS WITH APPROVED PRODUCTS

1:30 Comments by Session Chairpersons
Dr. William D. Spotnitz
Dr. Dean Toriumi

1:40 Brain Implantation Study in Rats to Evaluate the Safety, Biocompatibility, and Biodegradation of FloSeal® Matrix Hemostatic Sealant
Dr. Félix Vega, Director of Preclinical Biology, Baxter Bioscience - Fremont
The presentation will describe an in-vivo study in rats to evaluate the safety, biocompatibility and biodegradation of FloSeal Matrix following its implantation into the brain of Sprague-Dawley rats. Additional commercially available hemostatic agents tested included Avitene, Gelfoam and Surgicel. The median time to biodegradation was 30 days for FloSeal, >90 days for Gelfoam + Thrombin, >90 days for Avitene, and = 60 days for Surgicel.

2:10 Vivostat® Patient-Derived Fibrin Sealant is a More Rapidly Effective Hemostat than Oxidized Cellulose (Surgicel®) in Cardiothoracic Surgery
Dr. H. K. Kjaergard, Gentofte Hospital
This presentation will discuss the outcomes of a study to compare the hemostatic properties of patient-derived fibrin sealant (Vivostat®, Vivolution, Denmark) with oxidized cellulose (Surgicel®, Ethicon, USA) in cardiothoracic surgery. (Coauthor: Dr. D. A. Hollingsbee)

2:40 Safe Use of FloSeal® Matrix Hemostatic Sealant Around Small Blood Vessels: Rabbit Carotid Artery Anastomosis Study
Dr. Felix Vega
Healing of the anastomosis site of blood vessels treated with FloSeal, Surgical or thrombin-soaked Gelfoam was evaluated in a rabbit model. In addition, the biocompatibility of each of these topical hemostatic agents was assessed. FloSeal was shown to be safe and biocompatible when used at anastomotic sites on vessels with a diameter of 1.0 - 1.5 mm, did not cause vessel constriction, and vessel patency was not affected.

3:10 Poster and Exhibit Viewing, Refreshment Break

3:40 Fibrin Sealant Improves Hemostasis in Polytetrafluoroethylene Grafts
Dr. Worthington G. Schenk, III, University of Virginia
A prospective, randomized study was performed to evaluate the efficacy of fibrin sealant (FS) in patients undergoing upper extremity poly-tetrafluoroethylene (PTFE) graft placement for dialysis. This procedure is a reproducible, clinically relevant model for evaluating FS in vascular surgery. (Coauthors: Sandra Burks, B.S.N., Charles A. Goldthwaite, Jr., and William D. Spotnitz, M.D.)

4:10 Preclinical Evaluation of FloSeal® Matrix Hemostatic Sealant for Urological Applications
Dr. Daniel P. Polidoro, Research Scientist, Baxter Bioscience - Fremont
Three different models of surgical lesions of the kidney were used to evaluate the hemostatic effectiveness of FloSeal and another commercially available hemostatic agent (Instat™), compared to a control group (compression only). In each of the models, the time to hemostasis in the FloSeal and Instat groups was significantly less than the control. No clinical signs or blood chemistry abnormalities indicating renal dysfunction were noted in any animals. FloSeal is biocompatible when used in the kidney and biodegraded within thirty days in this model.

4:40 Going Forward
Dr. Martin MacPhee and Dr. William D. Spotnitz
This presentation will be a summary of this year's meeting and a discussion of the direction this meeting should take in the future, so as to better meet the needs of the industry.

5:10 Close of Conference

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HOTEL INFORMATION
Hyatt Regency San Francisco
5 Embarcadero Center
San Francisco, CA 94111
T: 415-788-1234 o F: 415-398-2567
Room Rate: $219.00 s/d
Cut-off Date: September 12, 2002
Please call the hotel directly to make your room reservation. Identify yourself as a Cambridge Healthtech Institute conference attendee to receive the reduced room rate. Reservations made after the cut-off date or after the group room block has been filled (whichever comes first) will be accepted on a space-and-rate-availability basis. Rooms are limited, so please book early.

TRAVEL INFORMATION
Special Zone and Discount Fares have been established for this conference with United Airlines. Please call United Airlines Meeting Reservation Desk at 800-521-4041 and reference ID #579YS.

CALL FOR SPONSORS AND EXHIBITORS
CHI's Seventh Annual Tissue Sealants and Adhesives will provide the unique opportunity to interact with the leading manufacturers of tissue sealants and adhesives and cover many aspects of their research and development. Companies interested in reaching researchers involved with fibrin sealants, collagen and thrombin, cyanoacrylates, polyethylene glycol polymers, and cross-linked albumin, as well as the design or use of tissue sealants, adhesives and hemostatic agents, should sponsor and/or exhibit at this event. The advance rate deadline of August 9, 2002 is fast approaching-registering to exhibit before that date will save your company up to $250! For more information on sponsorship opportunities or to reserve a booth, please contact Deborah Brooks at 781-972-5412 or dbrooks@healthtech.com.

CALL FOR POSTERS
Cambridge Healthtech Institute encourages attendees to gain further exposure by presenting their work in the poster sessions. Please fill out the registration form, with the poster title and primary author. To ensure inclusion in the conference binder, a one-page abstract must be submitted and registration must be paid in full by September 6, 2002.  Click here for poster instructions

I am interested in presenting a poster at Tissue Sealants and Adhesives and will submit a completed one-page abstract by September 6, 2002. (Please Note: Registration must be paid in full to present poster.)