Intuitive Surgical on Monday provided more details about its new cardiac surgery initiative for the da Vinci 5 robot, including specifying nine procedures that received U.S. clearance.
Among those are mitral and tricuspid valve repair, mitral valve replacement, and left atrial appendage closure — procedures that comprise key businesses for heart device companies such as Boston Scientific, Abbott and Edwards Lifesciences.
Intuitive said cardiac procedures with da Vinci 5 can enable surgeons to operate through small incisions without splitting the breastbone, which is typically required in open heart surgery.
“This clearance reflects our commitment to advancing minimally invasive cardiac surgery so more surgeons and care teams can pursue improved outcomes for their patients,” CEO Dave Rosa said in a statement.
In addition to the valve and LAA indications, the FDA clearance covers internal mammary artery mobilization for cardiac revascularization, patent foramen ovale closure, atrial septal defect repair, atrial myxoma excision and epicardial pacing lead placement. All nine procedures use non-force feedback instruments.
The update comes after Intuitive executives told analysts on an earnings call last week that the Food and Drug Administration had cleared the robot for cardiac surgery.
Limited U.S. launch
Intuitive said it plans to begin working with a limited number of U.S. sites through 2026 to establish da Vinci 5 cardiac programs.
The robot is already cleared for cardiac surgery in South Korea, and the company is pursuing cardiac approvals in Europe and other geographies.
A dedicated team, focused on clinical evidence generation and the development of training programs and cardiac-specific instruments and accessories, will support the global initiative. The company expects to help cardiac care teams adopt robotic-assisted surgery programs that are “consistent, scalable and sustainable,” said Darla Hutton, Intuitive’s global vice president of cardiac surgery.
Recommitting to cardiac
Cardiac surgery was cleared on the original da Vinci system in 2002. Intuitive said more than 140,000 robotic cardiac procedures in 51 countries have been performed since then using da Vinci systems.
However, technical limitations of first‑generation platforms and the lack of a global training and support infrastructure caused the company to shift its focus away from the specialty, Intuitive said. With those barriers now addressed, minimally invasive cardiac surgery is positioned for “meaningful expansion” with da Vinci 5, the company said.
