Capstan Medical’s robot platform has been used for the first in-human robotic assisted transcatheter mitral valve replacement procedures, confirming the company’s credentials in joining the increasingly crowded surgical robotics market.

The landmark procedures were performed at a hospital in Chile, though the US company did not elucidate further details on the clinical programme.

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“We are honoured to pioneer this innovation that has the potential to transform how we treat heart valve disease, especially for patients who aren’t candidates for conventional surgery,” said Dr Gonzalo Martinez, who performed the procedures.

Colleague Dr Santiago Garcia said the system provided stability and control, helping achieve optimal implant positioning. He reported that both patients who underwent the procedure had their mitral regurgitation eliminated.

Capstan’s platform combines surgical robots with catheter-based technology to provide a less invasive option for open heart procedures.

Surrounded by companies deploying robotic platforms for a wide portfolio of indications, Capstan instead has gone down the specialist route, stating its mission is to ‘transform the treatment of structural heart disease’. Mitral valve replacement is its initial target, though future clinical and development work is planned on the back of $100m raised in a Series C round in December 2024.

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Mitral valve replacement is a procedure that replaces the patient’s damaged valve with a new valve, either made from biological or mechanical structures. More than seven million people in the US have heart valve disease, which includes dysfunction from any one of the heart’s four valves.

Capstan’s method starts with conventional catheter placement using a guidewire. Once in the right atrium, a robotic controller takes over to advance the catheter into the left atrium and optimise the replacement valve’s position next to the diseased mitral valve. After the valve is unsheathed, the platform “allows for precise positioning across three dimensions”. The company has not unveiled what the valve is made from nor further details about the robot.

The da Vinci surgical system is currently the only US Food and Drug Administration (FDA) approved robotic system used for cardiac surgical procedures. However, experimental platforms for specialist cardiovascular procedures are emerging. This includes a platform used by heart surgeons at the WVU Heart and Vascular Institute to perform the world’s first combined robotic aortic valve replacement and coronary artery bypass grafting (CABG) procedure in December 2024.

Through a wider lens, the surgical robotic system market is poised for a potentially transformative year ahead. Medtronic is aiming to disrupt da Vinci’s long-held domination in the US market, planning to apply for its Hugo robot to the FDA. Smaller companies are also gaining traction, with Ronovo Surgical and Horizon Surgical looking to use proceeds from $44m and $30m financing rounds raised respectively last year.

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