Santa Cruz, California–based Capstan Medical said it’s the first time a minimally invasive robotic structural heart platform has been used in clinical practice.
“Today marks a pivotal moment in the evolution of structural heart therapy,” Capstan Medical CEO Maggie Nixon said in a statement shared with MassDevice ahead of the announcement. “Seeing the capabilities of our system, catheter, and implant come together to deliver groundbreaking human cases validates years of research, development, and unwavering commitment from our team. This achievement demonstrates the potential of our technology to reshape the future of structural heart procedures.”
Nixon had more to add in an interview with MassDevice.
“The team did an impeccable job preparing for these cases, and the patients are doing great, which is what it’s all about,” she said.
Capstan Medical’s mitral valves were implanted in two patients at Hospital Clínico Universidad Católica in Santiago, Chile, by Dr. Gonzalo Martinez, director of the Endovascular Therapy Center at Pontifical Catholic University of Chile.
“We are honored 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,” Martinez said in a statement shared with MassDevice. “The Capstan technology exceeded our expectations even in these early cases.”
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The cases were supported by Dr. Santiago Garcia, director of the Structural Heart Program at The Christ Hospital in Cincinnati, Ohio. Garcia said the first-in-human cases “represent a significant leap forward in structural heart intervention.”
“I’ve worked with numerous technologies, but this fundamentally changes what’s possible in the treatment of valvular heart disease,” he said in a statement. “The robotic platform provided unprecedented catheter stability and control, achieving optimal implant positioning. Both patients had elimination of their mitral regurgitation, with unobstructed left ventricular outflow tracts, and are feeling much better than how they arrived. This is the enabling technology the structural heart field has been waiting for.”
Nixon said the latest milestone means Capstan Medical is still on track with clinical and development work to start a pivotal trial next year, with submission to the FDA for regulatory approval as soon as 2028.
“We’re moving very carefully and methodically, but we’re likely to treat about eight to 10 patients in this case series in multiple locations,” Nixon said. “We’ll probably be in about three to four different sites, and we’re screening patients for that right now.”
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Capstan will present more information and early clinical imaging at the Cardiovascular Research Technologies meeting in Washington, D.C. this weekend, she said.
The startup raised $110 million in its Series C round last year. Shortly after, Capstan hired an ex-Intuitive engineer to lead R&D and offered an update on its technology, including its efforts to develop a tricuspid valve implant.
Go to Medical Design & Outsourcing for more from our interview with Nixon about this first-in-human milestone, the latest on Capstan Medical’s regulatory strategy, and an update on the company’s tricuspid technology.
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