Skin closure innovator ZipLine® Medical, Inc., an innovator in skin closure, has gained approval for its Zip® Surgical Skin Closure device in India. In addition
Background
One we’ve been watching for a while now, the Zip is a non-invasive and easy to use skin closure device that replaces sutures, staples and glue for surgical incisions and lacerations.
This clearance from India’s Central Drugs Standard Control Organization (CDSCO), will give the company access to the $3.5 billion medical device market in India, including growing specialties where the Zip has shown significant clinical and economic benefits, such as total joint replacement in orthopedics, and Cesarean-section and hysterectomy in obstetrics and gynecology.
The news is bolstered by additional clinical evidence, newly published study results from the University of Florida demonstrating an 18 percentage point higher tissue perfusion rate versus baseline with the Zip compared to staples (p<0.001) after closure for total ankle replacement procedures. The results were presented in a poster at the American College of Foot and Ankle Surgeons (ACFAS) conference in Las Vegas in March.
Previous clinical studies have demonstrated significant time savings and less procedure variability that can decrease hospital costs and improve efficiencies. Studies have also demonstrated fewer wound complications, and the comfortable and simple removal can reduce post-discharge home health and clinic visits that affect overall healthcare cost in a bundled care environment.
Physician comments
Jason Piraino, DPM, MS, FACFAS, who presented the results, commented, “Maintaining adequate perfusion is one of the most important factors in ensuring wound healing. High perfusion correlates to fewer complications, such as dehiscence and infection. The Zip demonstrated a significant perfusion advantage over staples in our study.”
Source: ZipLine Medical, Inc.
published: May 10, 2017 in: Approval/Clearance, Clinical Studies/Trials, Gynaecology/Obstetrics, Orthopaedics