We’ve covered ZipLine Medical before as it progresses its clever non-invasive skin closure device to market. Now the company has reported that it has begun shipping products for commercial use.
ZipLine Medical’s core platform, which it calls PRELOC™ (Pre-placement RE-aligning LOw-tension Closure), is a noninvasive surgical skin closure designed to provide a suture-like outcome at the speed of staples, with easy reapposition and alignment of the incision edges during closure.
The company says the technique is simple, the device easy-to-learn and easy-to-use.
The breathable monofilm base device may be applied before an incision is made (to facilitate reapproximation of incision edges), or may be applied during skin closure to accommodate procedures such as Cesarean-section scar revision. By pulling the zipped tags to close the device, tension in surrounding skin is bridged over and around the incision, resulting in a low-tension and uniform distribution of closure forces, when compared to point load forces found with staples and sutures.
There are other benefits too: Since no skin piercing is involved, there is a reduced risk of surgical site infection (SSI) and needle stick injury. The transparent materials used means the area surrounding the incision can be monitored, as well as supporting retraction and maintaining access to the incision site during healing for monitoring and treatment. After the incision has healed, the device is easily removed by simply peeling from skin; no instruments or special skills are required, reducing the need for an additional patient return visit for staple or suture removal. The ZipLine PRELOC may be used for incisions up to 15 cm in length.
The devices are classified by the U.S. FDA as ‘Class I, Exempt.’
“Traditionally, closure of large incisions has required sutures at the skin surface, a sometimes time-consuming process. Alternatively, staple closure saves time, but causes a worse final appearance of the wound. Now, with the ZipLine device, we can achieve both goals: better cosmesis and time savings,” said David C. Gorsulowsky, M.D., Dermatologic Surgeon and Associate Clinical Professor, University of California San Francisco. Dr. Gorsulowsky is one of the first commercial adopters of this new technology.
“Of course, the commercial launch of our products is a very significant milestone for ZipLine Medical,” said John Tighe, President and CEO. “Given that skin-closure is the common denominator of nearly all surgical procedures, ZipLine’s PRELOC™ technology platform for skin closure has extensive applicability across multiple medical specialties. Our initial target applications include pacemaker/ICD implant, spine and hip orthopedic, excisional skin biopsy and laceration closure,” said Tighe.
Source: ZipLine Medical, Inc.