Intuitive receives CE mark for da Vinci 5 system for cardiac procedures

Intuitive has received CE mark approval in Europe for its da Vinci 5 surgical system for adult cardiac procedures. The clearance covers thoracoscopically-assisted cardiotomy procedures and minimally invasive coronary artery bypass procedures.

Cardiovascular diseases remain the leading cause of death worldwide, claiming nearly 18 million lives annually. In the European Union, they accounted for one-in-three deaths in 2022. Most open heart surgeries worldwide annually require a sternotomy, an approach involving splitting the breastbone, but robotic-assisted surgery offers procedures through smaller incisions.

Dirk Barten, Intuitive's commercial president for Europe, stated that this clearance signifies the company's commitment to reintroducing robotic-assisted minimally invasive cardiac procedures in Europe. The company is offering new instrumentation suitable for cardiac procedures, along with a comprehensive ecosystem including training and support.

Robotic-assisted cardiac surgery has a long history in Europe, but past technical limitations and the absence of dedicated training infrastructure slowed its expansion. With the da Vinci 5 CE-marked for cardiac surgery and a mature ecosystem, Intuitive believes minimally invasive cardiac surgery is positioned to scale across Europe. The company is reinforcing its long-term commitment through regulatory investment, partnerships with cardiac societies, and the da Vinci 5 as a future-ready platform.

The da Vinci 5 system's design supports minimally invasive cardiac procedures by enabling surgeons to operate through small incisions without opening the breastbone. Features include significantly enhanced computing power, 'smart' instrumentation capturing real-time data, advanced imaging, and an integrated digital ecosystem supporting the entire care pathway.