Impactor has allowed the creation of the start-up company ImpacTell, who is developing an innovative and patented medical device with a proof of concept established in preclinical studies. The objective of this surgical hammer, a class Im medical device named Smart-Hammer, is to provide orthopedic surgeons with a decision support tool to ensure an objective and optimal conduct of surgical protocols during total hip replacement (THR). This new tool responds to an unmet clinical need to obtain a reliable estimate of primary stability, which is the main determinant of surgical success. Starting in 2026, ImpacTell will help surgeons achieve optimal primary stability of implants while reducing the risk of intraoperative fracture or necrosis due to excessive mechanical stress on the bone.
ImpacTell was created in November 2022 by Stéphane Perche (President), Félix Berriat (General Manager) and Guillaume Haïat (Scientific Director). Guillaume Haïat is a graduate of the Ecole Polytechnique and Director of Research at the CNRS (French National Center for Scientific Research). He is the inventor of the technology. He has 15 years of experience in academic and industrial research in implantology. Stéphane Perche is an entrepreneur with a degree from the École Polytechnique and extensive experience in management, finance and strategy. He was a director of Deutsche Bank in London. Félix Berriat is a graduate engineer from the École Polytechnique. After a master's degree in biotechnology at the Technical University of Denmark, he completed a PhD at the Paris Brain Institute.
The implants used in THR are impacted with a hammer to ensure their stability. The technology used is based on an instrumented hammer that allows analysis of the temporal variation of the force exerted by the hammer on the implant during an impact. The insertion of the implant into the bone leads to a stiffening of the bone-implant system which is measured at each impact by our hammer equipped with a piezoelectric force sensor. Quantitative and objective data reflecting the primary stability of the implant (which is the main criterion for surgical success) is provided to the surgeon in real time. This information allows the surgeon to adapt the number and energy of impacts to reduce the risk of i) aseptic loosening and ii) intraoperative fracture, which leads to a reduction in re-do's and complications as well as a safer surgical procedure. This technology does not require any additional action on the part of the surgeon and does not modify the surgical protocol. The proof of concept has been validated in studies on anatomical subjects very close to the clinical situation.
By optimizing primary stability during surgery, Smart-Hammer will reduce the rate of revision prostheses due to aseptic loosening and periprosthetic fractures. The cost of a first-line THR is estimated at approximately €10,000 in France and $40,000 in the United States. For the patient, a failure implies the need for a revision surgery, the cost of which is approximately 30% higher than the initial intervention. For the practitioner, a failure has important consequences on his or her reputation and the trust granted by the patient. As our market study in France shows, orthopedic surgeons are interested in the Smart-Hammer, which does not modify the operating protocol and provides additional assurance of good fixation of the THR, including for the training of young surgeons.
