FDA Clearance Expands Robotic Options for Minimally Invasive Heart Surgery

Cardiovascular disease remains the world’s leading cause of death, with nearly 18 million fatalities each year, and more than two million patients undergo open-heart surgery annually, most involving sternotomy. As hospitals seek minimally invasive alternatives that maintain precision for complex cardiac interventions, Intuitive’s da Vinci 5 has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for selected cardiac procedures using non-force feedback instruments.

Da Vinci 5 is a robotic-assisted surgical system designed to perform thoracoscopic cardiac procedures through small incisions, eliminating the need to open the breastbone. The platform features a reported 10,000-fold increase in computing capacity to support future digital capabilities, while smart instrumentation captures more than 1,000 data points per second. Advanced imaging improves visualization of vessels and tissue perfusion, and an integrated digital ecosystem connects workflows from preoperative planning to postoperative analytics.

The new indication covers selected thoracoscopically assisted cardiac procedures using non-force feedback instruments. These include mitral valve repair and replacement, tricuspid 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, and epicardial pacing lead placement. The clearance specifically highlights mitral valve repair and internal mammary artery mobilization among the expanded uses.

Cardiac surgery was the first specialty cleared on the original da Vinci system in 2002. Since then, more than 140,000 robotic-assisted cardiac procedures have been performed using da Vinci systems across 51 countries. Intuitive has established a dedicated team to support adoption of cardiac surgery with da Vinci 5, with efforts focused on infrastructure development, bespoke training programs, generation of clinical evidence, and cardiac-specific instruments and accessories. A limited number of U.S. sites will begin working with the company through 2026 to establish da Vinci 5 cardiac programs.

“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 chief executive officer 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.”

“Da Vinci 5 marks the beginning of a global initiative to help transform cardiac care,” said Intuitive’s global vice president 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.”

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