Chinese FDA Nod for ZipLine® Medical’s Non-Invasive ZIP® Skin Closure System

Skin closure specialist ZipLine® Medical, Inc., has announced China Food and Drug Administration (CFDA) approval and commercial availability of its Zip® Surgical Skin Closure device.

Background

A previous visitor to our pages, ZipLine describes its Zip as a non-invasive, efficient and easy to use wound closure device that replaces traditional sutures, staples and glue for surgical incisions and lacerations. Use of the device results in a comfortable, secure wound and the device’s unique force distribution system results in high patient comfort and excellent scar quality. The Zip’s micro-adjustability and reversibility provides surgeons with precise control and flexibility during closure. Because application and removal are simple, clinicians can delegate the closure task and, at the clinician’s discretion, patients may remove the Zip at home. Unlike staples or sutures, there are no skin punctures with the Zip, so scarring is minimal and there are no added pathways for bacteria to enter. The Zip’s benefits have been demonstrated in clinical studies in orthopedic total-joint arthroplasty, cardiothoracic surgery, electrophysiology and dermatology.

Chinese clearance will give the company access to the $543 million Chinese wound closure device market serving over 40 million procedures, including growing specialties where the Zip has shown significant benefit, such as orthopedics for total joint replacement and obstetrics for Cesarean-section and hysterectomy procedures.

ZipLine Medical recently featured the Zip at the prestigious 11th International Congress of the Chinese Orthopaedic Association, held in Beijing.

Company comments

“The non-invasive Zip closure is ideally suited for the healthcare market in China, in light of its large and growing procedure volume, need for cost-effective and efficient solutions, and appreciation of aesthetics,” said ZipLine Medical’s President and Chief Executive Officer John Tighe. “We look forward to working with our team of distribution partners across China to bring the speed, safety, comfort and convenience of Zip to Chinese patients.”

Source: ZipLine

Share your thoughts

Your email address will not be published.