smallRW.gif (2706 bytes) Surgical 'Zipper' Marks a New Era for Wound Closure A New Twist on an Age-Old Device
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SAN FRANCISCO, Oct. 11 /CNW-PR Newswire/ -- Surgeons have a new option for closing patient wounds following surgery. 

ATRAX(TM) Medical Group Ltd. announced today from the 85th Annual Clinical Congress of the American College of Surgeons that after final review by the U.S. Food and Drug Administration (FDA), the MEDIZIP(TM) Surgical Zipper has been exempted from the premarket notification requirements of the Federal Food, Drug and Cosmetic Act and may be immediately marketed. Using this product, surgeons can now apply a novel technique called "zippering" to close wounds. Zippering is a non-invasive, atraumatic skin closure system that is a unique alternative to older methods of wound closure such as suturing, stapling, taping, and the recently introduced gluing.

"In an age of high-tech medical advances, zippering is a low-tech, yet highly effective approach to dealing with a critical element of the surgical procedure," said Dr. Robert Ellis, a cardiac surgeon at the Western Heart Institute, St. Mary's Hospital in San Francisco, California. "In fact, the MEDIZIP(TM) Surgical Zipper holds the potential of revolutionizing surgical wound care management in many procedures."

The MEDIZIP(TM) Surgical Zipper has been used extensively in tens of thousands of patients worldwide. It has demonstrated significant advantages for clinicians and patients in closing surgical incisions. It also shows promise of providing economic benefits for hospitals due to potential savings in operating room time and the time required for removal, especially important in today's medical economic environment.

The original zipper was first patented in the United States in August, 1893. It was years, however, before the original zipper found a practical purpose. Today, the MEDIZIP(TM) Surgical Zipper is indicative of the remarkable utility of this versatile invention. The MEDIZIP(TM) Surgical Zipper may be used for surgical incisions and lacerations up to 47 cm in length and has been evaluated in general surgery, orthopedic surgery, neurosurgery, vascular and heart surgery, abdominal and gynecological surgery.

Surgeons and Patients Benefit

"Having personally used the zippering technique in more than 300 surgical procedures, I can confirm that the MEDIZIP(TM) Surgical Zipper saves time in the operating room and is, therefore, a cost-effective option," said Rita Altman, P.A.-C, PA Surgical Associates, Atlanta, Georgia. "Additionally, most patients experience greater post-operative comfort, pain-free removal and are very satisfied with their experience," she added. For the clinician, zippering is faster than suturing and eliminates the threat of needle stick injuries from sutures used for final skin closure. Also, in contrast to traditional sutures or staples, zippering avoids further trauma to the wound area. In the hospital, the speed of zippering suggests operating room efficiencies, potentially reducing the cost of nursing staff and anesthesia time.

Simple, Effective Technique

The MEDIZIP(TM) Surgical Zipper combines a zipper and two multi-layered adhesive support strips. After surgery, the strips are adhered to both sides of the surgical incision. As the zipper is closed, it draws the edges of the wound together, securing atraumatic closure of the wound.

"The apparent simplicity of the MEDIZIP(TM) Surgical Zipper masks its sophistication. It is truly a remarkable product," said Greg Engel, Manager of Marketing and Regulatory Affairs for ATRAX(TM) Medical Group Ltd. "Our ability to now market the product in the United States is a major milestone in the evolution of surgical wound care management."

A surgeon's goals in caring for a wound are to apply clinically effective techniques to achieve wound closure, reduce the risk of surgical wound infection and produce a high quality cosmetic result. The zippering technique provides an effective, easy to use, non-invasive alternative to currently practiced techniques.

ATRAX(TM) Medical Group Ltd. at the 85th American College of Surgeons Congress

The Annual Clinical Congress of the American College of Surgeons is one of the largest meetings of surgeons in the world. This year, the six-day meeting is being held at the Moscone Convention Center in San Francisco, California. Please make sure to visit the ATRAX(TM) Medical Group Ltd. Booth No. 1545 for more information on the MEDIZIP(TM) Surgical Zipper.

ATRAX(TM) Medical Group Ltd., a wholly owned subsidiary of ATRAX(TM) International Ltd., is a Bermuda-based company devoted to the development, manufacturing and distribution of innovative medical devices and technologies. ATRAX(TM) Medical Group Ltd. expects to make the MEDIZIP(TM) Surgical Zipper commercially available in the United States through its planned North American distribution network by early 2000. The MEDIZIP(TM) Surgical Zipper is also approved for use in all of western Europe, most of central Europe, China, and Canada.

SOURCE: ATRAX Medical Group Ltd.

ST: California

This press release may not be redistributed without prior written approval by PR Newswire.

Posted October 11, 1999.

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