Intuitive Receives CE Mark for da Vinci 5 in Adult Cardiac Surgery
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. The clearance positions minimally invasive cardiac surgery to scale across Europe, supported by a mature ecosystem and dedicated training infrastructure.
Cardiovascular disease remains the leading cause of death worldwide, claiming nearly 18 million lives each year, and accounted for one in three deaths in the European Union in 2022. More than two million patients worldwide undergo open heart surgery annually, with most procedures requiring a sternotomy, an approach that involves splitting the breastbone to open the chest and access the heart. Robotic-assisted cardiac surgery has a long tradition in Europe, with the first cardiac procedures using the da Vinci system performed in France and Germany in 1998. While early milestones demonstrated clinical potential, technical limitations and the absence of dedicated training infrastructure led Intuitive to sequence its expansion around more adopted procedures. With da Vinci 5 now CE-marked for cardiac surgery and a mature ecosystem in place, 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.
The design of da Vinci 5 supports minimally invasive cardiac procedures by enabling surgeons and their teams to operate through small incisions without opening the breastbone. The system offers 10,000x computing power for future innovation and digital solutions, smart instrumentation capturing more than 1,000 data points per second, advanced imaging for enhanced visualization of vessels and perfusion, and an integrated digital ecosystem supporting the complete journey from pre-operative planning through post-operative analytics. In Europe, the system will come with a full set of instruments suitable for cardiac procedures, including new Class III instruments.
To support adoption of cardiac surgery with da Vinci 5, Intuitive has established a dedicated team focused on building infrastructure, including bespoke training programs, clinical evidence generation, and future cardiac-specific instruments and accessories. The company will partner with a limited number of centers across Europe in 2026 and beyond to establish reproducible programs that create the foundation for long-term scale.
Dirk Barten, Intuitive’s Commercial President for Europe, said the clearance represents a firm commitment to bring back robotic-assisted minimally invasive cardiac procedures in Europe. Barten noted that the company is strongly aligned with 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.
Darla Hutton, Intuitive’s Global Vice President of Cardiac, said the CE mark for adult cardiac procedures with da Vinci 5 is an important step in a broader global effort to help transform cardiac care. Hutton noted that by bringing together 30 years of innovation, team-based training, and a service model built on reliability and safety, the company believes it can help cardiac teams adopt robotic-assisted surgery in a way that is consistent, scalable, and sustainable.
