Da Vinci 5 receives CE mark for cardiac procedures

Intuitive’s da Vinci 5 surgical system has received CE mark approval for adult cardiac surgery in Europe.
Commercial president for Europe, Dirk Barten, said that the clearance, including for thoracoscopically assisted cardiotomy procedures and minimally invasive coronary artery bypass procedures, represents ‘a firm commitment to bring back robotic-assisted minimally invasive cardiac procedures in Europe’.
Robotic-assisted cardiac surgery has a long tradition in Europe; the first cardiac procedures with the da Vinci system were performed in France and Germany back in 1998. While early milestones demonstrated clinical potential, technical limitations and the lack of a dedicated training infrastructure led Intuitive to sequence its expansion around more widely adopted procedures.
The da Vinci 5 design supports minimally invasive cardiac procedures by enabling surgeons and their teams to operate through small incisions, improving patient outcomes and recovery times.
The system offers:
10,000x computing power for future innovation and digital solutions
Smart instrumentation capturing 1,000+ data points per second, coming to Europe with a full set of instruments suitable for cardiac procedures, including new class III instruments
Advanced imaging for enhanced visualisation of vessels and perfusion.
An integrated digital ecosystem supporting the complete journey from pre-operative planning through post-operative analytics.
Intuitive’s global vice president of cardiac, Darla Hutton, said: ‘CE mark for adult cardiac procedures with da Vinci 5 is an important step in a broader global effort to help transform cardiac care. 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 has established a dedicated team focused on infrastructure development, including:
- Bespoke training programmes
- Clinical evidence generation
- Future cardiac-specific instruments and accessories.
The first cardiac procedures using the da Vinci system were performed in France and Germany in 1998, but expansion into cardiac surgery was previously sequenced around more established procedures because of technical limitations and the lack of dedicated training infrastructure.