Functional recovery after peripheral nerve repair is one of the biggest challenges in surgery. Polyganics offers a portfolio of three PNR products as key additions to the surgeons’ toolkit, to improve surgical outcomes and support patient recovery.
Our products facilitate diverse repair approaches by capping (NEUROCAP®), bridging (NEUROLAC®), and protecting (VIVOSORB®) the nerve.
Webinar: Surgical Management of Neuropathic Pain
In this October newsletter, first of all we’d like to draw your attention to a webinar from earlier this year in which Dr Dominic Power, Consultant Hand and Peripheral Nerve Surgeon at the Queen Elizabeth Hospital, UK, discusses “challenges in the surgical management of nerve pain”. Dr Power covers processes and techniques, results and case studies, in this in-depth educational webinar. Feel free to share this webinar, in which products from our PNR portfolio are being discussed, with your customers.
PROTECT NEURO Data (NEUROCAP®) presented at ASSH 2020
24-month data from our PROTECT NEURO (PRospective cohOrt evaluaTion of nEuroCap in the Treatment of symptomatic NEUROma) study was recently presented at the 75th ASSH Annual Meeting.
PROTECT NEURO is a multi-center (EU and US), post-market clinical follow-up study, investigating the long-term (up to 24 months) performance and ease of use of NEUROCAP® in reducing development of peripheral symptomatic end-neuromas in the upper and lower extremities.
The follow-up data showed that treatment of peripheral symptomatic end-neuromas with NEUROCAP® reduces pain, disability and analgesic use in the majority of upper limb end-neuroma patients. This can significantly improve patients’ quality of life and daily functioning. No recurrent symptomatic upper-limb end-neuromas were observed. A time frame of 24-months has never been shared for alternative approaches before.
NEUROCAP® Surgical Case Report
NEUROCAP® has also been under the microscope in Birmingham, UK. Surgeons at the University Hospitals Birmingham NHS Foundation Trust have published a Surgical Case Report in which they excise and analyze an end-neuroma six months after capping with NEUROCAP®.
This analysis of our bioresorbable polycaprolactone cap is the first of its kind in a human model. The authors conclude that the results will improve understanding of how such materials behave and influence nerve regeneration, which will help tailor future innovations.
VIVOSORB® User Experiences
VIVOSORB® is a flexible bioresorbable polymer film, indicated for use as a temporary protective sheet to separate opposing soft tissues and minimize tissue attachment. We have collected user experiences, which we encourage you to share with your customers, describing the use of VIVOSORB® in surgeries of the upper extremities and spine.
VIVOSORB® User Experiences in upper extremities
Recently, VIVOSORB® has been used in several cases in the upper extremity. The main goal was to avoid any tissue attachment after surgery. Cases performed are, amongst others, Tenolyse and Neurolyse (nerve release after CTS release). Surgeons were asked to give feedback on the procedure, outcome, including follow-up, and usability of VIVOSORB®
In most cases VIVOSORB® was sutured [1]. In those cases where the device was not anchored using suture, it still showed good positioning. Between two weeks and two months post-operatively, all cases showed good wound healing and accurate positioning of VIVOSORB®. After three months, further improvement of functionality was demonstrated, with no pain at the affected area and an effective outcome. The results for all cases (in some up to seven months) were positive, showing good functionality, and an absence of pain for the patient.
No adhesions or adverse events have been reported. All patients recovered well.
The usability of VIVOSORB® was judged as good to very good in all cases. VIVOSORB® is flexible, easy to wrap and easy to position on the target anatomy. Depending on the situation and surgeon’s perspective VIVOSORB® can be easily anchored with a suture.
VIVOSORB® User Experiences in spinal surgery
We also wanted to share two additional reports of VIVOSORB® being used by orthopedic surgeons as a separation sheet in spinal surgery. In both cases, VIVOSORB® was cut to size and used to cover the exposed nerve root and dural sac as a temporary protective sheet to avoid adhesion with the opposing soft tissue.
In the first report, Dr Carmine Zoccali at the Regina Elena National Cancer Institute, Rome, Italy, describes his experience using VIVOSORB® in more than 50 procedures to avoid adhesion after spinal fusion surgery.
Dr Zoccali reported no complications or adhesions at 3- and 6-month follow-up and described VIVOSORB® as “simple and efficient” to use.
In the second report, Dr Maarten Ellis at Rivierenland Hospital, Tiel, the Netherlands, reports the results of surgeries with 57 consecutive patients treated for a single-level herniated lumbar disc.
Dr Ellis describes the easy mini-open technique used to apply VIVOSORB®, as well as reporting the outcomes. No adverse reactions were observed, nor any cases involving progressive neurologic deficit, infection, or spinal fluid leakage.
We hope this series of user experiences will be a useful resource, enabling you to demonstrate the ease of use and effectiveness of VIVOSORB® and show your customers that this product is a vital addition to the surgeons’ toolbox.
Note: All user experiences described in this newsletter are intended solely to provide information. The views and opinions expressed by the users are those of that user and not, necessarily, of Polyganics. Polyganics does not guarantee or assume any legal liability or responsibility for the accuracy, completeness, or usefulness of any information disclosed.
[1] Always fixate the sheet with non-absorbable sutures or absorbable sutures, consistent with IFU for this product
