Intuitive announced that the U.S. Food and Drug Administration (FDA) cleared the da Vinci 5 robotic surgical system for certain cardiac procedures, including mitral valve repair and IMA (internal mammary artery) mobilization for cardiac revascularization.

Cardiac surgery was the first specialty cleared on the original da Vinci system in 2002. Since then, over 140,000 robotic-assisted cardiac procedures have been performed using da Vinci systems in 51 countries.

Although early milestones showed clinical potential, a combination of technical limitations of first-generation platforms and absence of a global training and support infrastructure led the company to shift primary focus away from cardiac surgery. Now with those barriers addressed and a mature ecosystem in place, minimally invasive cardiac surgery is positioned for meaningful expansion with da Vinci 5.

Da Vinci 5’s design supports minimally invasive cardiac procedures by letting surgeons operate through small incisions without opening the breast bone. The robot boasts 10,000x computing power for future innovation and digital solutions, as well as smart instrumentation that captures over 1,000 data points per second.

It also features advanced imaging for better visualization of vessels and perfusion. An integrated digital ecosystem supports the complete journey from pre-op planning through post- op analytics.

“Da Vinci 5 marks the beginning of a global initiative to help transform cardiac care,” said Intuitive’s global VP of cardiac Darla Hutton. “By combining 30 years of meaningful innovation, structured team-based training programs and a service model built on reliability and safety, we believe we can enable cardiac teams to adopt robotic-assisted surgery in a consistent, scalable and sustainable way.”

The company has established a team focused on building infrastructure, including development of bespoke training programs, clinical evidence generation, and cardiac-specific instruments and accessories. A limited number of U.S. sites will begin working with Intuitive through 2026 to establish da Vinci 5 cardiac programs.

The surgical robot is now indicated for several thoracoscopically-assisted cardiac surgical procedures using non-force feedback instruments, including: mitral valve repair, IMA mobilization for cardiac revascularization, patent foramen ovale closure, atrial septal defect repair, left atrial appendage closure/occlusion, atrial myxoma excision, mitral valve replacement, tricuspid valve repair, and epicardial pacing lead placement.

“Opening the chest to perform surgical procedures can involve significant pain, high risk of complications, and long recovery times that can affect patients’ physical and psychological wellbeing,” said Intuitive CEO Dave Rosa. “This clearance reflects our commitment to advancing minimally invasive cardiac surgery so more surgeons and care teams can pursue improved outcomes for their patients.”

Last month, the da Vinci SP (single port) system won FDA clearance for use in inguinal hernia repair, cholecystectomy, and appendectomy procedures.