No. As tennis elbow / epicondylalgiais a chronic disease, TendoVis™ can be administered anytime when the problem is presented to you.
The clinical study results were obtained after 2 injections. We believe that the optimum results can be seen if the full therapeutic cycle is followed (that is, 2 injections with an interval of 1 week).
Additional administrations of TendoVis™ during follow up assessments can be done, since TendoVis™ contains STABHA™ (biocompatible Hyaluronic Acid).
Injections were be administered into the soft tissue 1 cm from the lateral epicondyle at the point of greatest pain in two planes using a fanning technique whereby contents were injected on withdrawal of the needle from the point of maximal tenderness in a single puncture.
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.
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.
TendoVis™ was not created to replace the practice of standard care. It is advised that TendoVis™ and standard of care should be used concomitantly.
TendoVis™ is not listed as a doping agent and can be used on athletes of all standards.
TendoVis™’s main ingredient is STABHA™ (Soft Tissue Adapted Biocompatible Hyaluronic Acid).
Once STABHA™ is introduced to the site, it performs the following activities:
• It reacts with cellular fibronectin to create a scaffold which facilitates and controls the cellular migration at the injury site. This scaffold is able to promote healing as it acts as a barrier by limiting the access of macrophages and lymphocytes to this site.
• STABHA™is also helps in re-organising the fibrils in fibres and fascicles as well as restoring the fibres into their normal parallel arrangement.
• STABHA™ provides the injury site structural support as well as acts as a healing component.
STABHA™ which is contained in TendoVis™ is believed to increase the quality of healing thus reducing scar tissue formation.
It was shown in the clinical study that patients using TendoVis™ went back to their daily activities within a specific amount of time 18 (±11) days whereas this was not seen in the control group.
TendoVis™ is an effective and efficient method of quantitative and qualitative management of tennis elbow / epicondylalgia. Results from using TendoVis™ show that benefits have been seen even 1 year later.
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 residence time in the soft tissue allows TendoVis™ to achieve maximum interactions with torn ligaments and tendons.
This is the studied optimal volume for tennis elbow 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.
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If you might have further questions which have not been included in here, please feel free to contact us