Laparoscopy is an operation performed in the abdomen or pelvis using small incisions with the aid of a camera. To create workspace for the surgeon during laparoscopy, the abdomen is inflated using gas. Here the surgeon faces a dilemma: apply sufficient gas pressure for a safe workspace to see and operate, while keeping the pressure as low as possible for the patient. Managing this trade-off is key to prevent pain, reduce hospital stay, prevent complications and reduce severe risks for vulnerable patients.
Spatium Medical introduces the world’s first medical insufflator that ensures stable workspace at lowest insufflation and ventilation pressure with three patented technologies addressing three unmet needs.
- Personalized insufflation pressure – Currently, surgeons have to guess the appropriate pressure input, leading to higher pressures than necessary in 78% of surgeries2. Surgeons need a means to determine the patient-specific insufflation pressure3.
Oscillometry measurement: Spatium Medical’s technology can measure the patient’s abdominal wall compliance to determine the lowest pressure needed while maintaining sufficient workspace.
- Stable insufflation pressure – Current insufflation devices cannot provide consistent pressure. Surgeons resort to raising the insufflation pressure higher than required to compensate for instability.
Turbine technology: Contrary to conventional insufflators Spatium Medical uses turbine technology in combination with a reservoir, enabling accurate pressure management. Our in-vitro studies indicate that a 2 – 7x more stable workspace in patients can be achieved.
- Adaptation to mechanical ventilation – Insufflation pressure leads to increased mechanical ventilation pressure5. This puts the patient at risk for pulmonary complications. There is a need to lower the required mechanical ventilation pressure by synchronizing the insufflation with mechanical ventilation.
Reciprocal insufflation: Due to real time adjustment, mechanical ventilation pressures are reduced by up to 10%. This reduces pulmonary complications regardless of the chosen insufflation pressure.
The Spatium Medical team includes the inventors and clinicians and is led by Van der Bijl, who has 20+ years’ experience in commercialising medical devices. Erasmus MC and Politecnico di Milano validated the technologies in pre-clinical in-vivo studies10 (>30 porcine animals). The technology will be tested in-human in 2023. We are developing the product for series production, aiming for CE certification in 2025.
The total addressable market (TAM) is valued at €1.1 billion (15 million laparoscopies in 2022 and growing). We will target the EU and US markets (SAM) (9 million laparoscopies per year). We aim to capture a 20% market share within 8 years of market entry resulting in yearly peak revenues of €132 million.