March 6, 2025-Capstan Medical, a cardiovascular innovation company, announced that it has successfully completed a transcatheter mitral valve replacement using its new implant and surgical robotic system. This is the first time a minimally invasive robotic structural heart platform has been used in clinical practice and marks a pivotal moment in the development of structural heart therapies.
In a statement shared with MassDevice prior to the announcement, Capstan Medical CEO Maggie Nixon said,“Today marks a pivotal moment in the development of structural heart therapies. Seeing the functionality of our system, catheter and implant come together to deliver groundbreaking human cases validates our team’s years of research, development and unwavering commitment. This achievement demonstrates the potential of our technology to reshape the future of structural heart surgery.”
Nixon further added in an interview with MassDevice,“The team did an impeccable job of preparing for these cases, and the patients recovered well, which is what it’s all about for us.”
The procedure was performed by Dr. Gonzalo Martinez, Director of the Endovascular Therapy Center of the Catholic University of Chile, at the Clínico Hospital of the Catholic University of Chile in Santiago, Chile, where two patients were implanted with Capstan Medical’s mitral valves.Dr. Martinez commented, “We are honored to be able to pioneer this innovation that has the has the potential to change the way we treat heart valve disease, especially in patients who are not candidates for traditional surgery. Even in these early cases, the Capstan technology has exceeded our expectations.”
Dr. Santiago Garcia, Director of the Structural Heart Disease Program at Christ’s Hospital in Cincinnati, Ohio, also expressed his support for the procedure. He called the first-in-human case “a major leap forward in structural heart interventions” and emphasized, “I’ve worked with many techniques, but this fundamentally changes what’s possible in the treatment of valvular heart disease. The robotic platform provided unprecedented catheter stability and control for optimal implant positioning. Mitral regurgitation was eliminated in both patients, the left ventricular outflow tract was unobstructed, and the patients felt much better than they did prior to surgery. This is the enabling technology the structural heart field has been waiting for.”
Capstan Medical’s technological innovation is the combination of surgical robotics, catheterization and a new generation of heart valve implants to develop a solution that allows for the treatment of mitral and tricuspid valve disease through a catheter while the heart is beating. This solution provides a less invasive alternative to traditional direct cardiac surgery, resulting in improved patient outcomes and shorter recovery times.
Nixon said the latest milestone means Capstan Medical remains on track with its clinical and development work, with plans to begin a pivotal trial next year and submit it to the US Food and Drug Administration (FDA) for regulatory approval as early as 2028. She revealed, “We’re moving very cautiously and methodically, but we may treat about eight to 10 patients in this case series at multiple sites. We will probably be performing the procedure at about three to four different sites and are screening patients now.”
In addition, Capstan Medical plans to present more information and early clinical imaging at the Cardiovascular Research Technology Conference in Washington, D.C., this weekend. The startup raised $110 million in a Series C funding round last year to advance the development and marketing of its technology. Shortly afterward, Capstan also hired a former intuitive engineer to lead R&D and provide updates on its technology, including its efforts to develop a tricuspid valve implant.
Capstan Medical’s success not only brings new hope for heart valve disease patients, but also sets a new benchmark for the entire medical robotics field. With the continuous development and improvement of the technology, we believe that Capstan Medical will bring benefits to more patients in the future.
