The injection is best performed within the first 48 hours because of it is at that point that the maximum of fibrin is present but can be given anytime up to about the 8th day post injury if there are still symptoms.
It can be given soon after the injury once it is properly assessed and stabilised (i.e. within 2 hours of the injury).
TendoVis™ can still be injected even if the first 48 hours are missed as TendoVis™ might still be able to help the patient recover faster and better even if the recommended injection time frame is missed.
The recommended treatment window to complete the treatment is 8-10 days.
Extremely positive results are seen after 2 injections. Healthcare professionals could inject once more under their own reponsability if they feel clinically the patient need it. The 2-3 days interval before injection number 2 is to give the injury time to rest.
If the conditions are adequate for an injection, it can be done on the sideline within minutes of the injury. The earliest injection from injury time during the clinical trial of TendoVis was performed about one hour after the sprain.
TendoVis™ is not listed as a doping agent and can be used on athletes of all standards.
Injection into a haematoma shoudn’t be performed. A proper assessment of the injury is vital.
Injury site is first located and assessed.
Injection is done with 1 puncture following 3 phases using anatomical landmarks.
Locate the area of exquisite tenderness – usually anterior to lateral malleolus (sometimes at distal TFL site)
Inject TendoVis™ into area of exquisite soreness anterior to CFL using Fanning technique proximally (fibular insertion) to distally (calcaneal insertion) along the lateral malleolus.
A third of TendoVis™ content is released into the injury site during withdrawal of the syringe during each of the 3 phases. At the end of the injection process, the syringe should be empty.
In case of injury to another ligament, another syringe of TendoVis™ can be administered in sequence of the first injection if required.
More on the Injection technique: see our video on the fanning technique
TFL: Talofibular ligament
CFL: Calcaneo fibular ligament
The fanning technique is essential to the administration of TendoVis™ as it ensures a physical distribution of TendoVis™ which allows larger surface area coverage of the soft tissue for maximum repair.
TendoVis™’s main ingredient is STABHA™ (Soft Tissue Adapted Biocompatible Hyaluronic Acid).
During the first phase of healing, inflammation at the injury site results in the generation of a fibrin matrix. Due to its high biocompatibility with the soft tissue, TendoVis™ interacts with the fibrin matrix.
Moreover TendoVis™ has a quieting effect on cells and helps to limit inflammation, optimise recovery and relieve pain at the injury site.
TendoVis™ is believed to increase the quality of healing thus reducing scar tissue formation.
TendoVis™ is an effective and efficient method of quantitative and qualitative management of ankle sprains as TendoVis™ reduces the time to recovery.
TendoVis™ was not created to replace R.I.C.E.. It is advised that TendoVis™ and R.I.C.E. should be used concomitantly.
TendoVis™ is produced by an innovative manufacturing process which is patented. TendoVis™ is derived from continuous fermentation of Streptococcus equi.
After fermentation, the biomass is separated from the solution by filtration to obtain a cell-free solution. This solution is then purified by diafiltration to remove low molecular weight impurities (those derived from the production organism’s metabolism, the residual components of the nutrient medium). The precipitation of nucleic acids and endotoxins is obtained by the addition of a cationic surfactant.
This results in a purity profile that allows TendoVis™ to be biocompatible with soft tissues, with reduced chemical processes that would alter a sensitive polymer (e.g. pH, heat).
Molecular weight is not the focal point of TendoVis™ specific target. TendoVis™ design was focused specifically using a very carefully selected set of parameters that gives the optimal rheological properties, thus residence time in the soft tissue.
Purity is also another key factor instead of molecular weight. Both the purity profile and ideal residence time in the soft tissue allows TendoVis™ to achieve maximum interactions with the torn ligament.
No studies are available on mixing TendoVis™ with other medicines therefore this would be dependent on the judgement and responsibility of the Healthcare professional. But it is not advisable to mix it in the same syringe and let it rest as it would cause crystallization of the polymer.
This is the studied optimal volume for ankle sprain recovery as this volume has shown to be the most efficient in this case. A larger volume is not used so as not create too much pressure at the injury site.
We have a network of distributors worldwide. Please contact the distributor from your region or you may also contact us.
If you might have further questions which have not been included in here, please feel free to contact us