Intuitive Surgical (Intuitive) recently announced that the U.S. FDA has newly approved its da Vinci 5 surgical robot system for specific cardiac surgeries. Officially launched on January 26, the system's indications are expanding for the first time to include mitral valve repair and coronary artery bypass graft revascularization surgery.
This also marks the first official approval of cardiac surgery indications for the Da Vinci robot. According to Intuitive Surgical, globally, Da Vinci robots have already performed over 140,000 cardiac surgeries. The computational power of this robot system has been increased by 10,000 times.
Approximately 18 million people worldwide die from cardiovascular diseases each year, with over 2 million patients undergoing open-heart surgery, most of which require sternotomy. Using robots for minimally invasive cardiac surgery, which is performed through small incisions without opening the sternum, can reduce patient trauma. The approval of these new indications is also a significant milestone in the field of surgical robotics.
Notably, as early as 2002, cardiac surgery was the first specialty approved for clinical use with the first-generation Da Vinci system. However, due to technical limitations of the first-generation platform and a lack of global training and support infrastructure, Intuitive Surgical shifted its primary focus away from cardiac surgery to other areas, such as abdominal surgery.
A surgeon who uses the Da Vinci robot for surgery commented, "Robotic surgery extends the capabilities of the surgeon's eyes and hands, allowing doctors to see more clearly and perform more precise operations."
However, the newly approved system uses a robot without force-feedback instruments. Intuitive Surgical stated that, given the complexity of minimally invasive cardiac surgery, it plans a "measured rollout" and hopes that patients requiring cardiac surgery can benefit from Da Vinci's minimally invasive approach. The company also said that Da Vinci 5 robotic cardiac surgeries will initially be conducted in the United States and South Korea, with the potential to create up to 160,000 surgical opportunities annually in the future.
The use of robotic surgery is a trend in medical development. Intuitive Surgical predicts that the global volume of Da Vinci robotic surgeries is expected to grow by 13% to 15% in 2026.
Recently, tech billionaire Elon Musk has also expressed strong support for robotic surgery. He boldly predicted that within three years, robots will surpass humans in surgical skills; in four years, they will achieve a level of "complete superiority over any human doctor," and within five years, they will completely outperform human surgeons, including top-tier ones.
A cardiac surgeon who has experience with robotic surgery stated, "The development of surgical robots in areas like abdominal surgery is already quite mature, but in cardiac surgery, their current value appears to be limited to their potential in coronary artery bypass grafting."
Another cardiovascular clinician mentioned that whether cardiac patients can benefit from robotic minimally invasive surgery still requires further clinical observation and validation to draw conclusions.
Brokerage firm Truist Securities stated in an analysis report that Da Vinci 5's pioneering approval for cardiac surgery indications could further unleash the company's competitive advantages in the market. Currently, other medical giants are also developing surgical robot systems but have not yet entered the field of cardiac surgery. For example, the earliest indications for Medtronic's newly approved Hugo surgical robot system are in urology, and Johnson & Johnson's newly submitted Ottava surgical robot system is only intended for general surgery.
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