Intuitive Announces CE Mark Approval for da Vinci 5 in Cardiac Procedures
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.[i]
Cardiovascular disease remains the leading cause of death worldwide, claiming nearly 18 million lives each year.[ii] In 2022, it accounted for one-in-three deaths in the European Union.[iii] More than two million patients worldwide undergo open heart surgery annually,[iv] with most procedures requiring a sternotomy, an approach that involves splitting the breastbone to open the chest and access the heart.
“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.
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, 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. 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 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. The system offers:
- 10,000x computing power for future innovation and digital solutions.[v]
- Smart instrumentation capturing 1,000+ data points per second, coming in Europe with a full set of instruments suitable for cardiac procedures, including new class III instruments.
- Advanced imaging for enhanced visualization of vessels and perfusion.
- An integrated digital ecosystem supporting the complete journey from pre-operative planning through post-operative analytics.
“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 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 centers across Europe in 2026 and beyond to establish suitable, reproducible programs that create the foundation for long-term scale.
The value of the Intuitive system portfolio lies not only in individual products, but in how they work together, and in how we match the right systems to each customer’s surgical and institutional needs within the European healthcare system, connecting technology, education, insights, and optimization to enable sustainable, high-performing minimally invasive care across the patient pathway. The latest CE mark underscores this value and reinforces Intuitive’s commitment to help deliver sustainable minimally invasive care across Europe.
References:
i National Heart, Lung and Blood Institute (2022). ‘Heart Surgery’. Available at: https://www.nhlbi.nih.gov/health/heart-surgery
ii British Heart Foundation. UK Cardiovascular Disease Factsheet. 2026
iii Ricciardi, R. MD, MPH* et al. The COMPARE Study: Comparing Perioperative Outcomes of Oncologic Minimally Invasive Laparoscopic, Da Vinci Robotic, and Open Procedures: A Systematic Review and meta-analysis of The Evidence. Annals of Surgery, 2024
Source: Intuitive
