What’s next for Capstan Medical after their first-in-human robot-assisted transcatheter heart valve replacement

Capstan Medical CEO Maggie Nixon didn’t get much rest the night before the first-in-human procedure using the structural heart startup’s novel mitral valve implant and surgical robotics system.

“It’s a combination of excitement and nerves, and if you don’t have both of those, I don’t think we’d be doing it right,” she said. “There wasn’t a lot of sleep.”

“When you’re bringing out a first-in-human with an instrument on an existing platform, it’s one thing,” she later continued. “But it’s different bringing out the entire integrated system all at once. We made a decision as an organization to bring out the robot, the catheter and the implant all together, rather than a staged approach.”

In an interview with Medical Design & Outsourcing, Nixon discussed the strategy of moving forward with the entire minimally invasive system at once, feedback from those first cases, the latest on Capstan Medical’s regulatory efforts, and an update on the startup’s tricuspid valve technology.

“As we talked about in the past, we had an implant and a manual catheter before we had the robot. Initially, we were carrying on those programs in parallel, because you want to learn things about your implant, you want to learn things about your catheter, and you want to learn things about your robot, and we’re going to keep those going forward,” Nixon said. “But as we were looking at the scheduling, they were kind of converging, and every bit of information we had — both from our clinical advisors and our in-house teams — [indicated] the robot was going to be the right way. So we merged the programs and brought them all out together instead of doing it in stages, because it wasn’t going to be swings of a year. It was going to be swings of a couple of months.”

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Feedback from doctors on the first two cases didn’t indicate a need for any major tweaks or fundamental changes, Nixon said.

“Mitral is not an easy procedure. We went into our first-in-human and those cases went smoothly. A lot of that comes from the technology hitting on the right things we needed to do for that procedure. … We have the range of motion we need, we have the stability and control that we wanted, we’re finding patients to treat, and we’re not having any outflow obstructions. A lot of it is confirming that we’re on the right track. Our coordinated motion is working and our procedure workflow is working. We’ll stay the course right now.”

Capstan’s regulatory pathway

Capstan Medical is planning to file for FDA premarket approval (PMA) for the system as soon as 2028. The company has already filed a Q-Sub with the FDA and had what Nixon described as “a couple of good calls” with regulators.

“It’s been kind of fun. It’s really great to start to get down into the details of how we want to structure our future trials,” she said. “We’re starting by focusing on our implants. Sometimes that’s the longer-lead testing, so we want to make sure we’re deeply aligned with the agency on what testing is needed there. And then we’ve got our next round of questions already set up to make sure that we stay well aligned.”

Asked whether she’s concerned that cuts by the Trump Administration to the FDA could delay or hinder Capstan’s progress, Nixon said they’re “definitely tracking it closely.”

“We reached out to our review team and our review team hasn’t been impacted, but we’re very sensitive to the environment they may be experiencing right now,” she said. “We’re trying to work closely and be good partners.”

Similarly, her team is keeping an eye on Trump’s tariffs, though that’s less of an immediate concern.

“We are well positioned for ramping volumes even in our current footprint,” she said. “We actually have cleanroom capacity and capability to drive all the way into a pivotal trial.”

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The latest on Capstan’s tricuspid technology

Capstan has continued work on its tricuspid implant since our last conversation with Nixon in December 2024. That novel implant will come after the mitral valve technology, but Nixon said the tricuspid project is “ramping very quickly.”

The main goal has been selecting an initial annular size for that novel implant, which like the mitral valve implant uses nitinol to expand when placed inside a patient’s heart.

“That’s been our key focus, making sure we’re dialed in there. Other than that, it’s just fine-tuning that to move into production,” she said.

Celebrating Capstan’s first-in-human procedures

Capstan Medical’s first-in-human procedures were conducted in Santiago, Chile. That’s the same city where Medtronic‘s Hugo surgical robotics system was first used on a human, and it’s where surgical robotics developer Levita Magnetics has been conducting research.

“We’ve been incredibly impressed with Chile’s clinicians and capabilities, as well as the infrastructure they provide,” Nixon said. “They have been incredibly collaborative. We have protocols submitted, and we work very closely with their research coordinators and so on. The combination of skilled clinicians and and good infrastructure all wrapped up with a collaborative regulatory pathway makes it very reasonable to consider. … And they don’t have the full suite of products that are in investigation or on the market, so there’s patient need. When you bring that capability and that patient need together, it works really well.”

After Capstan’s first-in-human operation, Nixon held a Zoom meeting with the entire company to share the good news before filling the board in — and then toasted the milestone with a pisco sour.

“This is the culmination of years of work,” she said. “Bringing that integrated, seamless implant, catheter and robot together into these cases was incredible.”

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