Commercial Biomaterial-Based Products for Tendon Surgical Augmentation: A Scoping Review on Currently Available Medical Devices.

Abstract

Tendon defect is one of the common clinical diseases related to the growing population mean age and the number of athletes. Due to an increasing demand for tendon repair surgical interventions, several tendon augmentation products, capable of guaranteeing the necessary biological and visco-elasticity properties and mechanical support, have been developed. In this regard, commercially available products may be grouped into three main categories: (i) natural, (ii) synthetic, and (iii) hybrid biomaterial-based products. Firstly, to better define the research area of this work, common search engines were employed to acquire information from reports or website portfolios of important competitors in the global tendon repair market. Secondly, public registries and bibliographic databases were also employed to analyse data from registered clinical trials and published clinical studies performed to evaluate the safety and efficacy of each product. Ten new products have been launched on the market in the last fifteen years: advantages, disadvantages, and future perspectives regarding their use for tendon augmentation treatment are discussed. Although hybrid biomaterial-based products may be considered as more oriented to the new frontiers of tendon augmentation technology, future improvements, especially focused on both mechanical properties and biocompatibility, are needed. However, scientific innovations must navigate convoluted clinical regulatory paths, which, due to high costs for investors, long development timelines, and funding shortages, hinder the translation of many scientific discoveries into routine clinical practice.