Clinical Study Results Suggest ZipLine® Medical’s Non-Invasive Zip® Surgical Skin Closure Device Has Faster Closure Time than Sutures and Less Patient Pain
CAMPBELL, Calif., May 11, 2015—ZipLine Medical, Inc. announced today that several clinical studies are demonstrating the Zip® Surgical Skin Closure’s clinical and economic benefits in several medical specialties.
Early, unpublished results from a prospective, randomized clinical trial comparing Zip® to subcuticular sutures for incision closure on pacemaker and ICD implant patients at University of California, San Diego, suggest several advantages of the Zip vs. sutures. “We have seen significant reduction and less variance in closure time with Zip compared to sutures, and most patients have reported greater satisfaction and greater comfort with Zip,” commented Ulrika Birgersdotter-Green, M.D., Professor of Medicine, Director of Pacemaker and ICD Services at UCSD Medical Center, and principal investigator for the study. Scar cosmesis, as rated by surgeon, patient and an independent panel of plastic surgeons was similar in both closure methods. No closure device related adverse events were reported. Manuscript submission is anticipated mid- 2015.
The Zip has been adopted at key hospitals such as Hospital for Special Surgery in New York, which is the largest orthopedic hospital in the U.S. and ranked #1 by US News and World Report. “We use the Zip on TKA and Makoplasty incisions. It’s much faster than sutures and glue in the OR and results in a nice cosmetic outcome. With the increasing emphasis on overall procedure cost as well as patient satisfaction, we’re finding that we can reduce procedure time as well as keep our patients happy with the Zip. The Zip doesn’t puncture tissue and our patients are spared the pain, anxiety and track marks associated with metal staples,” said Andrew D. Pearle, M.D., Orthopaedic Surgeon at HSS. HSS is preparing to conduct a clinical study comparing the Zip to metal staples for total knee arthroplasty procedures to further quantify and compare the results with each method.
In Japan, favorable results from a 100-subject randomized, controlled prospective clinical study using the Zip® Surgical Skin Closure for wound closure and hemostasis after cardiac ablation will be presented by Yasuteru Yamauchi, M.D. at the upcoming Joint Meeting of The 30th Annual Meeting of the Japanese Heart Rhythm Society and The 32nd Annual Scientific Meeting of the Japanese Society of Electrocardiology on July 28, 2015.
“More and more surgical specialties are realizing that ZipLine offers increased patient satisfaction and also reduces overall healthcare costs,” said John Tighe, President and CEO of ZipLine Medical.
ZipLine Medical (www.ziplinemedical.com), founded by Amir Belson, M.D. and headquartered in Campbell, Calif., is a medical device company that has developed cost-effective, noninvasive surgical skin closure devices for suture-like outcomes at the speed of staples. Over 15,000 surgical procedures have been performed worldwide with Zip® Surgical Skin Closure devices. Because skin-closure is the common denominator of nearly all surgical procedures, Zip® Surgical Skin Closure devices have extensive applicability across multiple medical specialties. The Company’s addressable market opportunity is estimated at $4 billion worldwide. Zip® Surgical Skin Closure devices are classified by the U.S. FDA as ‘Class I, 510(k) Exempt’ and have received CE Mark. #####
Ronald Trahan, APR
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ZipLine and Zip are registered trademarks of ZipLine Medical, Inc.