Intuitive has received CE mark approval for its da Vinci 5 surgical system to be used in adult cardiac surgery in Europe.
The approval covers thoracoscopically assisted cardiotomy procedures and minimally invasive coronary artery bypass procedures, allowing cardiac teams to use the robotic-assisted platform for procedures that can be performed through small incisions rather than opening the breastbone.
Intuitive said the CE mark represents a return to robotic-assisted cardiac surgery in Europe.
The first cardiac procedures using the da Vinci system were performed in France and Germany in 1998.
The company said its expansion into cardiac surgery had previously been sequenced around more established procedures because of technical limitations and the lack of dedicated training infrastructure.
“This clearance represents our firm commitment to bring back robotic-assisted minimally invasive cardiac procedures in Europe,” said Dirk Barten, Intuitive’s Commercial President for Europe.
Cardiovascular disease remains the leading cause of death worldwide, accounting for nearly 18 million deaths each year.
More than two million patients undergo open heart surgery globally each year, with many procedures requiring a sternotomy to provide access to the heart.
The company will provide new instrumentation for cardiac procedures alongside training, infrastructure and support for surgical teams.
The company is establishing a dedicated cardiac surgery team to develop training programmes, generate clinical evidence and support the development of cardiac-specific instruments and accessories.
It plans to work with a limited number of European centres from 2026 to establish cardiac surgery programmes before expanding adoption more widely.
What is unique about the da Vinci 5 system?
The da Vinci 5 system includes smart instrumentation capable of capturing more than 1,000 data points per second, advanced imaging for visualisation of vessels and perfusion, and an integrated digital ecosystem covering pre-operative planning through to post-operative analytics.
Intuitive said the system has 10,000 times the computing power of its previous generation, providing a platform for future digital solutions.
