Medical Professionals: Devices

Closure Medical’s ground-breaking biomaterials technologies have led to the innovation of new medical devices that revolutionize healing and meet urgent clinical needs. We have several topical wound closure devices commercially available, and we are developing biomaterials for tissue sealant and surgical adhesive device applications.

Topical Wound Closure Devices
DERMABOND Topical Skin Adhesive
High-Viscosity DERMABOND Topical Skin Adhesive
DERMABOND ProPen
DERMABOND ProPen XL
Links about Dermabond

Internal Tissue Sealant and Surgical Adhesive Devices
Vascular Sealant
Future Product Applications Requiring Evaluation

Topical Wound Closure Devices

DERMABOND topical wound closure devices are safe and effective alternatives to conventional suturing and offer the meaningful clinical benefits of saving procedure time, causing less pain to the patient, providing excellent cosmetic results, and creating a microbial barrier against the common microorganisms associated with skin infections. The DERMABOND product platform is the core of our topical wound closure devices and is used to close and seal wounds caused by lacerations, surgical incisions, minimally invasive surgery, and cosmetic surgery.

• DERMABOND Topical Skin Adhesive
• High-Viscosity DERMABOND Topical Skin Adhesive
• DERMABOND ProPen
• DERMABOND ProPen XL
• Topical Wound Closure Device Labeling

DERMABOND Topical Skin Adhesive
Approved by the FDA in August 1998, DERMABOND adhesive offered a safe and effective alternative to conventional suturing for certain types of lacerations. Based on a proprietary 2-octyl cyanoacrylate technology which allows a device to contain a monomer at room temperature that can polymerize rapidly upon activation and form a tenacious bond, DERMABOND quickly found acceptance in emergency rooms and clinics all over the country. DERMABOND adhesive polymerizes on contact with moisture on the skin’s surface to form a strong but flexible film that allows the patient to go about routine daily activities, even showering.

DERMABOND has been found to create a microbial barrier over the wound and protect against the penetration of these bacteria, commonly associated with surgical site infections:

• Staphylococcus aureus
• Staphylococcus epidermidis
• Enterococcus faecium
• Escherichia coli
• Pseudomonas aeruginosa

DERMABOND can be used on short, long, and even deep lacerations or incisions, providing they are relieved of tension (subcutaneous and or deep dermal sutures may be required to relieve tension on particularly deep wounds) and easily approximated.

For more specific information on how to use DERMABOND products, please visit www.DERMABONDtraining.com.

DERMABOND adhesives

• Provide the strength of healed tissue at seven days in less than three minutes
• Offer three-dimensional strength that is at least three times stronger than N-butyl cyanoacrylate, another leading type of adhesive
• Help protect and seal out bacteria that can lead to infection
• Promote a moist wound-healing environment that has been shown to speed the rate of epithelialization
• Cause less pain and relieve anxiety over sutures, particularly important for pediatric patients
• Have been found to be as safe and effective as conventional sutures with equivalent cosmetic results
• Save valuable clinical time in that they can be applied more quickly than sutures, eliminating the need for the following process
  • Injecting a local anesthetic into the wound
  • Waiting for the anesthetic to numb the area
  • Closing the wound with sutures
  • Placing a dressing over the wound
• Slough off naturally over time (usually five to ten days), eliminating the need for a follow-up visit to remove stitches

For more information on DERMABOND, go to www.dermabond.com.

High Viscosity DERMABOND Adhesive
First released in the United States in January 2003, High Viscosity DERMABOND adhesive offers the same powerful adhesive strength as regular DERMABOND but in a special formulation that is six times thicker. The thicker formulation allows the clinician better control, minimizing adhesive runoff, which in turn allows for more precise application.

High Viscosity DERMABOND has been found to be equivalent to regular DERMABOND with regard to safe and effective wound closure, but with less adhesive migrating from the wound. Many physicians prefer the thicker formula, because it reduces runoff and offers better control to the physician applying the adhesive. This allows DERMABOND the potential to be used in areas where runoff concerns may have prevented the physician from using it.

For more information on DERMABOND, go to www.dermabond.com.

DERMABOND ProPen
The same six-times-thicker High Viscosity DERMABOND adhesive formulation is also available in a new medical device delivery system called Dermabond ProPen that substantially increases ease of use, adhesive control, expression efficiency, and precision placement. This advanced design delivers reduced procedure time, more expressed adhesive, and improved overall patient satisfaction. Like all DERMABOND products, the ProPen applicator requires no refrigeration and has no special storage requirements.

The ProPen applicator was designed with interchangeable applicator tips. Offered with each applicator is a new precision nozzle tip that delivers the benefits of High Viscosity DERMABOND Topical Skin Adhesive. The new adaptable, narrow applicator tip allows for fine line delivery of the adhesive, allowing surgeons more precision when using the adhesive on the face or near the eye. The design feature provides improved cosmetic outcome for the patient as well as dramatically reduces the risk of run-off.

For more information on DERMABOND, go to www.dermabond.com.

DERMABOND ProPen XL

DERMABOND adhesive is packaged in an award winning applicator delivery system. Read More >>

The ProPen XL Applicator System offers the same great advantages of the regular ProPen Applicator System with twice the expressed quantity of DERMABOND liquid adhesive. It is ideal for longer or complex surgical incisions, eliminating the need to use multiple packages and preparation, thereby reducing procedure time.

The ProPen Applicators (standard and XL) in conjunction with the DERMABOND Topical Skin Adhesive cost effectively reduces procedure time, renders excellent cosmesis, and maximizes patient comfort.

For more information on DERMABOND, go to www.dermabond.com.

DERMABOND Related Links
The following sites are valuable resources about DERMABOND medical adhesive devices.

• www.dermabond.com
• www.dermabondtraining.com
• www.ethicon.com
• www.acutecare.com/dermab.htm

Internal Tissue Sealant and Surgical Adhesive Devices

The goal of most surgeries is to return a diseased or injured tissue to normal function. Fundamental to insuring surgical success is the ability to prevent surgical or post-operative blood leaks in vascular surgeries, cerebral spinal fluid leaks in cranial or spinal surgery, digestive fluid leaks in gastrointestinal surgeries or air leaks in lung surgeries.

Our biomaterials have many conceivable applications in just about every medical specialty. Our internal tissue sealant and surgical adhesive device technology has been developed to have a major contributing impact on minimizing post-operative morbidity and mortality by reducing post-surgical pain and complications and expediting the healing process. From securely sealing blood, air or fluid leaks to forming strong material bonding to or between hard and soft tissues, our biomaterials have been shown in pre-clinical studies to perform remarkably well at achieving desired results in a myriad of sealing and adhesive applications quickly, safely and easily.

The unmet need is very large. Of the nearly 25 million open and minimally invasive surgical procedures performed annually just in the United States alone, better than half require blood, air or fluid leaks to be managed during or after surgery. About 10% require sometimes lengthy interventions by surgeons during the procedure to control the leaks and safely manage the patient into post-surgical recovery. Unfortunately, sometimes blood, air or fluid leak complications only become apparent after surgery. A reliably strong, and easy to precisely apply surgical sealant and adhesive that is also free from infectious or immunologic risks inherent to biologically derived products is needed and demanded by surgeons worldwide.

At Closure Medical, we have begun patient enrollment in an FDA trial evaluating the use of an absorbable vascular sealant developed for applications within the body. Our internal product platform consists of:

• Vascular Sealant (under FDA clinical trial)
• Future Product Applications Requiring Evaluation

Vascular Sealant
In the fourth quarter of 2003, Closure Medical began a clinical trial in the United States evaluating the safety and effectiveness for a vascular sealant that is based on its proprietary technology and formulated for use within the human body.

Future Product Applications Requiring Evaluation
The potential applications for an internal adhesive are as dazzling as the challenges that confronted Closure scientists in terms of creating an adhesive that was strong and flexible enough to seal an internal surgical incision or graft, yet be completely biocompatible and biodegradable inside the body. Closure Medical’s ground-breaking technologies and potential devices may be compatible with applications in the pulmonary, neuro, orthopedic, GI, oncologic, urologic, colo-rectal, gynecologic and general surgical specialties. We are currently developing customized biomaterial devices to address specific unmet surgical procedures needs all across the body. The future for our promising technology will be complete with platforms of solutions for advancing surgical success for physicians worldwide.