Polyganics VIVOSORB - Flexible Bioresorbable Polymer
Is a flexible bioresorbable synthetic polymer film that separates opposing soft tissues post-surgery to prevent scar tissue and unintended adhesions.
Vivosorb is indicated for use as a temporary protective sheet to separate opposing soft tissues where applicable in patients undergoing surgery, thereby minimizing tissue attachment.
Vivosorb is composed of a bioresorbable copolyester poly(DL-lactide--caprolactone) sheet. Vivosorb can be applied to temporarily separate opposing soft tissues. Vivosorb elicits a minimal acute inflammatory reaction of the surrounding tissue, which is followed by gradual encapsulation of the material by fibrous tissue. Degradation of the sheet occurs through hydrolysis leading to gradual reduction of molecular weight. The sheet remains its initial mechanical properties up to at least 8-10 weeks, whereafter rapid loss of mechanical strength and gradual mass loss occur. The final degradation products, lactic acid and -hydroxy hexanoic acid, are resorbed, metabolized and excreted by the body. The material is resorbed within approximately 16 months. Expected device lifetime is 24 months if stored between -18°C and 8°C.
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.
VIVOSORB® is a commercialized product, available worldwide through a number of distributors.
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. More information on this study can be found here.
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
- Notified body Dekra
- US market Device Class 2; FDA 510(k) number:
- K042811
- Product Code FTL
- Regulation number 21 CFR 878.3300
- Medical Specialty General and Plastic Surgery
- Owner/Operator Polyganics
- Owner/Operator number 9057333
- Establishment registration number 3004504732