Intuitive has announced that its da Vinci 5 surgical system has received CE mark approval for adult cardiac surgery in Europe, including thoracoscopically-assisted cardiotomy procedures and minimally invasive coronary artery bypass procedures.
“This clearance represents our firm commitment to bring back robotic-assisted minimally invasive cardiac procedures in Europe. We are strongly aligned with our customers, offering new instrumentation suitable for cardiac procedures as well as a complete ecosystem—including global training, dedicated infrastructure and support—so surgeons and care teams can deliver better outcomes for their patients,” said Intuitive’s commercial president for Europe, Dirk Barten.
The first cardiac procedures with the da Vinci system were performed in France and Germany back in 1998, though a combination of technical limitations and the absence of a dedicated training infrastructure led Intuitive to sequence its expansion around more adopted procedures.
With da Vinci 5 CE-marked for cardiac surgery, and a mature ecosystem now in place, minimally invasive cardiac surgery is positioned to scale across Europe, the company says in a press release. Intuitive is reinforcing its long-term commitment through regulatory investment, partnerships with global cardiac societies to define dedicated training pathways, and da Vinci 5 as a future‑ready platform to help drive the transformation in cardiac surgery, the company adds.
The design of da Vinci 5 can support minimally invasive cardiac procedures by enabling surgeons and their teams to operate through small incisions without opening the breastbone.
“CE mark for adult cardiac procedures with da Vinci 5 is an important step in a broader global effort to help transform cardiac care,” said Intuitive’s global vice president of cardiac, Darla Hutton. “By bringing together 30 years of innovation, team-based training, and a service model built on reliability and safety, we believe we can help cardiac teams adopt robotic-assisted surgery in a way that is consistent, scalable and sustainable.”
To support adoption of cardiac surgery with da Vinci 5, Intuitive says it has established a dedicated team focused on building infrastructure, including the development of bespoke training programs, clinical evidence generation, and future cardiac-specific instruments and accessories. Intuitive will partner with a limited number of centres across Europe in 2026 and beyond to establish suitable, reproducible programmes that create the foundation for long-term scale, it adds.
