MAGNITUDE Surgical was created in August 2019 by its founder, Nicolas Rousseau, in order to solve the many problems encountered with existing electrosurgery technologies and thus meet the recommendations for use of the High Authority of Health concerning the risks associated with the use of the electric scalpel* 1.
Indeed, for the HAS “electrosurgery is a high-risk technology for the patient who is operated on and can cause injuries or even death”. To solve this problem, it is recommended “the use of low voltage currents” and it is specified that “the risk of electrical dispersion is prevented by the use of bipolar mode”.
Although bipolar hemostasis allows very good coagulation quality, it does not allow cutting efficiently enough to replace a monopolar handle and its plate. In the absence of an alternative and despite the recommendations, the monopolar mode, although not recommended, is still very widely used.
For nearly 100 years, electric scalpels have been developed using monopolar technology, which requires the current to pass through the patient. This high voltage monopolar current leads to a large number of usage constraints, as well as risks for the patient and the surgeon. This technology can lead to “sudden death” of the patient, burns at the patient return plate and burns on the surgeon’s hands. Additionally, exposure to surgical fumes is toxic for all caregivers* 2 Surgical Smoke Coalition – Surgical fumes an underestimated health risk – June 2022.
Monopolar technology uses a voltage of up to 6000 Volts throughout the patient, while bipolar technology uses ten times less voltage, i.e. 600 Volts maximum and only through the tissues to be treated.
As a specialist in electrosurgery and the design of special machines, Nicolas ROUSSEAU surrounded himself with a strategic committee of experts to develop a disruptive technological alternative to replace the monopolar electric scalpel and its patient return plate, which are responsible for the majority of incidents related to electrosurgery.
The second objective was to develop a “frugal innovation”, to do better with less, in order to offer an eco-responsible care offer, using single use only if no other solution is possible.
Finally, limiting the environmental impact also means manufacturing this electrosurgery device in France, to avoid consuming single-use products, some of which must travel more than 8,000 km before being thrown away.
Based on these findings, Magnitude Surgical has developed, patented and industrialized the T.O.MTM (for Tripolar Open Multifunctional) electrosurgery device.
The T.O.MTM device replaces the two technologies (monopolar and bipolar) currently used by surgeons, by combining the advantages of these two technologies, but without their respective disadvantages. T.O.MTM can replace a large number of electrosurgery devices (including the monopolar handle and the patient return plate) and offers several features to adapt to all surgical procedures required for different surgical procedures in laparotomy.
However, the rotation of the blade electrode allows multiple geometric configurations with the matrix (cylindrical metal electrode opposite the blade electrode), and therefore multiple cutting and coagulation functions to adapt to all surgical expectations. Twelve functions are offered, the surgeon can therefore choose those that are best suited to his needs, without necessarily using them all.
In order to protect surgeons and healthcare teams as much as possible from the toxicity of surgical fumes, T.O.MTM can also integrate the ExtraTOMTM option to aspirate fumes, or to irrigate tissues in order to quickly limit significant hemorrhagic bleeding.
T.O.MTM has benefited from an eco-design approach from the start of the project, to position itself as a sustainable alternative. The T.O.MTM instrument is reusable, and only the elements presenting a technological risk have been designed for single use, but by reducing their weight as much as possible. For example, the T.O.MTM blade electrode represents 4 grams of waste per intervention, when a single-use monopolar electric scalpel weighs approximately 100 grams, to which must be added its single-use patient return plate, which weighs approximately 20 grams.
TOMTM therefore makes it possible to divide by thirty the weight of the waste generated by a monopolar handle and its single-use patient return plate.
Eco-responsibility also means limiting the number of instruments needed for surgery. T.O.MTM can replace several other existing electrosurgery instruments, such as bipolar scissors, plate cable, irrigated bipolar forceps, bipolar forceps, bipolar forceps with smoke aspiration, etc. with a single device.* 3 ; 4 ; 5 & 6
* 1 – How to manage the risks associated with the use of the electric scalpel?
(Validation :October 2018 / Diffusion:November 2018).
https://www.has-sante.fr/upload/docs/application/pdf/2018-11/1_ssp_be.pdf
* 2 – Surgicalsmoke coalition – Surgical smoke an underestimated health risk – June 2022
* 4 – HAS – Health environment roadmap – November 2023
* 5 – Roadmap – Ecological planning of the health system – May 2023