Uncontrolled healing following trauma from surgery or inflammation can result in soft tissue attachments and adhesions. Such post-operative adhesions are of high clinical significance as they are associated with many serious complications including loss of motion, obstruction and pain.
To improve surgical outcomes and patient recovery it is necessary to minimize these post-operative adhesions. They may otherwise complicate future surgeries, extend operating times or increase pain experienced by the patient in the immediate or longer term.
Polyganics’ VIVOSORB® film is indicated for use as a temporary protective sheet, to separate opposing soft tissues during the critical healing process post-surgery, and minimize uncontrolled healing and unwanted adhesions.
The bioresorbable polymer film is flexible and transparent, facilitating easy manipulation and optimal positioning during surgery. VIVOSORB® acts as a barrier to enable tissues to regenerate in a controlled manner, preventing the ingrowth of scar tissues and minimizing formation of attachments. The sheets can be used in a variety of soft tissue surgery applications, wherever temporary wound protection and tissue support is required.
After application the sheets retain their mechanical properties for up to ten weeks, providing support and protection to the healing tissue. The film is then processed via the body’s natural systems. It is gradually degraded via bulk hydrolysis and resorbed within 16 months, then metabolized and excreted.
Currently, our flexible bioresorbable polymer film, VIVOSORB®, is being evaluated at UZLeuven, for use in segmental fasciectomy surgeries for finger deformities caused by Dupuytren disease. Twenty patients will be enrolled. Follow-up will continue for 12 months after surgery.
Our quality management system is ISO13485:2016 certified by Dekra Certification BV, a standard for quality management systems for design, manufacturing and distribution of medical devices. We also comply with the USA FDA 21 CFR 820 corresponding subparts and other applicable regulatory requirements for medical devices.
|European market||Device class: Class III|
|EC Notified Body||Identification number: 0344|
|US market||Device Class 2; FDA 510(k) number:
|Regulation number||21 CFR 878.3300|
|Medical Specialty||General and Plastic Surgery|
|Establishment registration number||3004504732|