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FDA clearedFDA cleared. Stage 4 of 4 (Authorized)

FDA Clears Intuitive's da Vinci 5 for Mitral Valve Repair and Other Heart Procedures

The 510(k) clearance covers nine thoracoscopically assisted cardiac procedures with instruments that lack force feedback, and Intuitive plans to start with a limited number of US hospitals this year.

By News DeskJanuary 27, 20262 min read
Foot pedals on the base of a da Vinci Xi surgeon console
Foot controls of a da Vinci Xi surgeon console at the Vesoul hospital in France. Not the da Vinci 5 system described in this article. A.BourgeoisP, CC BY-SA 4.0, via Wikimedia Commons · CC BY-SA 4.0
FDA cleared510(k)FDA cleared. Stage 4 of 4 (Authorized)

The FDA cleared this device through the 510(k) pathway, which finds it substantially equivalent to a device already on the market. Clearance is not the same as approval.

Key points

  • Intuitive said on January 26 that the FDA cleared its da Vinci 5 surgical system for selected cardiac procedures through 510(k).
  • The nine listed procedures include mitral valve repair and replacement, tricuspid valve repair, internal mammary artery mobilization and left atrial appendage closure, all using non-force feedback instruments.
  • Intuitive said a limited number of US sites will begin working with it through 2026 to set up da Vinci 5 cardiac programs.

Intuitive said on January 26 that the US Food and Drug Administration has cleared its da Vinci 5 robotic surgical system for selected heart procedures, including mitral valve repair, through the 510(k) pathway, according to the company's release distributed by GlobeNewswire, read via BioSpace.

The release says da Vinci 5 is now indicated for selected thoracoscopically assisted cardiac surgical procedures using non-force feedback instruments. It lists nine: mitral valve repair, internal mammary artery mobilization for cardiac revascularization, patent foramen ovale closure, atrial septal defect repair, left atrial appendage closure or occlusion, atrial myxoma excision, mitral valve replacement, tricuspid valve repair and epicardial pacing lead placement.

Intuitive did not give a 510(k) number or a clearance date in the release.

A return to cardiac surgery

Intuitive said cardiac surgery was the first specialty cleared on the original da Vinci system, in 2002, and that more than 140,000 robotic-assisted cardiac procedures have since been performed with da Vinci systems in 51 countries. The company said technical limits of first-generation platforms and the lack of a global training and support infrastructure led it to shift its main focus away from cardiac surgery, and that it now considers those barriers addressed.

According to the company, da Vinci 5 lets surgeons operate through small incisions without opening the breastbone. Features it highlighted include what it describes as 10,000 times the computing power, instruments that capture more than 1,000 data points per second and imaging for visualizing vessels and perfusion. These are Intuitive's own descriptions.

"This clearance reflects our commitment to advancing minimally invasive cardiac surgery so more surgeons and care teams can pursue improved outcomes for their patients," said Dave Rosa, Intuitive's chief executive, in the release.

Rollout

Intuitive said it has set up a dedicated team to build training programs, generate clinical evidence and develop cardiac-specific instruments and accessories. A limited number of US sites will begin working with the company through 2026 to establish da Vinci 5 cardiac programs, it said.

"Da Vinci 5 marks the beginning of a global initiative to help transform cardiac care," said Darla Hutton, Intuitive's global vice president of cardiac, in the release. The clearance does not cover da Vinci 5's force feedback instruments, which the indication excludes by name. The company did not disclose pricing.

Sources

  1. Da Vinci 5 Cleared for Cardiac Procedures (distributed by GlobeNewswire, read via BioSpace), Intuitive via BioSpace, January 26, 2026