Dive Brief:
- Intuitive said its da Vinci 5 surgical robot received CE mark approval this week for adult cardiac surgery in Europe, including coronary artery bypass procedures.
- Although the first cardiac procedures with a da Vinci system date back to 1998 in France and Germany, the robotics leader said that technical limitations of its first‑generation platforms led the company to shift its focus to more widely adopted procedures instead.
- Intuitive said it is now in a position to scale up minimally invasive cardiac surgery across Europe, supported by the new CE mark and partnerships with global cardiac societies to establish training pathways for the procedures.
Dive Insight:
Cardiac surgery represents a large market opportunity, with cardiovascular diseases the leading cause of death worldwide. CFO Jamie Samath told investors on Intuitive’s second-quarter earnings call that cardiac procedures are among the company’s most anticipated long-term opportunities.
The heart surgery strategy comes as Intuitive experienced an unexpected slowdown in U.S. procedures growth in the second quarter.
Intuitive is also ramping up its cardiac initiative in the U.S. Earlier this year, the company revealed that da Vinci 5, its most advanced system, had received Food and Drug Administration clearance in nine heart procedures, including mitral and tricuspid valve repair, mitral valve replacement and left atrial appendage closure.
The design of da Vinci 5 enables surgeons to operate through small incisions without opening the patient’s breastbone.
The robot maker plans to offer new instruments for cardiac procedures and provide a dedicated infrastructure to support customers, said Dirk Barten, Intuitive’s commercial president for Europe.
“This clearance represents our firm commitment to bring back robotic-assisted minimally invasive cardiac procedures in Europe,” Barten said in a statement.
The company said it is also focused on clinical evidence generation and will partner with a limited number of European centers to establish reproducible cardiac surgery programs for scaling up.
