After first being founded to chase robotic heart surgery — before a decades-long pivot into high-volume gynecologic, urologic and general procedures — Intuitive recently re-entered the space by picking up a broad cardiac clearance from the FDA in January.
The latest CE mark covers certain coronary artery bypasses, as well as thoracoscopic cardiotomy procedures, which access the interior of the heart through small incisions that avoid opening up the breastbone.
“This clearance represents our firm commitment to bring back robotic-assisted minimally invasive cardiac procedures in Europe,” said Dirk Barten, Intuitive’s commercial president for the continent.
“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,” Barten said in a statement.
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The company’s first da Vinci system made its international debuts in France and Germany in 1998, including the latter’s Leipzig Heart Center where it was employed for valve repair and coronary bypass grafts.
However, technical challenges and slow adoption among heart surgeons pushed Intuitive to instead develop its popular approaches for prostate removal and hernia repair, among other procedures. The fifth generation of its robot — the da Vinci 5 — obtained its CE Mark in mid-2025, for abdominal and pelvic procedures, with planned upgrades announced this past summer.
For cardiac surgery, the company is touting a dedicated team to develop education programs as well as instrumentation and accessories, alongside a plan to partner with a limited number of centers in Europe this year before scaling up to broader commercial operations in the future.
“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,” said Intuitive’s global VP of cardiac surgery, Darla Hutton, who was promoted to the position early last year.
