ZipLine Medical Reports Positive Clinical Study Results for Skin Closure Device

It’s been touting such claims for quite some time, but now ZipLine Medical Inc. finally has clinical proof of the superiority of its Zip Surgical Skin Closure product.

Several clinical studies have demonstrated the clinical and economic benefits of the Zip device in several medical specialties. Early results from a prospective, randomized clinical trial comparing Zip to subcuticular sutures for incision closure on pacemaker and ICD (implantable cardiac defibrillator) 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,” said 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.

The Zip has been adopted at such healthcare institutions as the Hospital for Special Surgery (HSS) in New York, N.Y., the largest orthopedic hospital in the United States and top-ranked 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., orthopedic surgeon at HSS. The hospital 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 were presented by Yasuteru Yamauchi, M.D., at the 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 late last month.

“More and more surgical specialties are realizing that ZipLine offers increased patient satisfaction and also reduces overall healthcare costs,” said John Tighe, president/CEO of ZipLine Medical.

Founded by Amir Belson, M.D., and headquartered in Campbell, Calif., ZipLine Medical has developed noninvasive surgical skin closure devices for suture-like outcomes at the speed of staples. More than 15,000 surgical procedures have been performed worldwide with Zip Surgical Skin Closure devices, the company claims. Zip Surgical Skin Closure devices are classified by the U.S. Food and Drug Administration as Class I, 510(k) Exempt and have received the CE Mark.