Adapting versatile polymers to deliver a pipeline of medical devices serving unmet clinical needs

We have developed and commercialized three products in the PNR space. VIVOSORB^® is a flexible bioresorbable polymer film designed to separate opposing tissues throughout the critical healing process.

Post-Operative Adhesions Minimization in Soft Tissue Surgery

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.

VIVOSORB^® Properties

Synthetic material; co-polymer of lactide and caprolactone; these are well known biocompatible and safe polymers
Transparancy and flexiblity of the device, for optimal positioning

Degradation at a predictable rate, minimizing the formation of tissue attachments (adhesions)
Controlled mechanical strength and flexibility for a period of 10 weeks, providing tissue support during the critical healing period

Product Information

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.

Clinical Information

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.

Regulatory Information

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.

Classification details

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

Resource Library

Further information on VIVOSORB^®, including technical specifications and regulatory certificates, can be found in our Media centre.

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