Capstan Medical says it has notched a first in the treatment of structural heart disease, employing a robot to implant two people with mitral valve replacement devices.
Current treatment options for heart valve disease exclude too many patients who are not good candidates for existing procedures, said Capstan CEO Maggie Nixon, and the company hopes its approach will provide them with a new alternative.
The Santa Cruz, California-based startup is developing a valve implant, catheter and robotic delivery platform to expand structural heart intervention to a broader group of people.
“There need to be more percutaneous, minimally invasive options to help treat valve disease,” Nixon said in an interview.
The first two patients in Capstan’s human trial recently were successfully treated for mitral regurgitation, where blood leaks back to the heart because the valve does not close properly.
Development of minimally invasive procedures to address mitral and tricuspid disease has lagged progress in aortic valve treatment, where Edwards Lifesciences and Medtronic are the leaders in a market that has shifted to transcatheter replacement from open heart surgery over the past two decades.
The mitral and tricuspid valve anatomies are considered more complex and difficult to treat. “When you start looking at mitral and tricuspid, they have different challenges than the aortic intervention,” said Nixon.
More than 80% of patients who seek mitral replacement with devices currently under investigation are excluded due to anatomical constraints, according to Nixon.
Transcatheter procedures already on the market for mitral disease have largely focused on repairing the patient’s existing heart valve. Abbott makes the MitraClip repair device that treats mitral valve regurgitation and the TriClip device for tricuspid regurgitation. Edwards has the Pascal system for mitral and tricuspid valve repair. Last year, Edwards also gained Food and Drug Administration approval for the Evoque tricuspid valve replacement.
Capstan engineers saw a way to address challenges in the mitral anatomy by designing a compact valve that does not block the cardiac outflow tract, which pushes blood out to the body through the aorta. The potential for obstruction of the outflow tract is one of the biggest reasons patients are excluded from investigational treatment options, Nixon said.
The Capstan valve’s delivery catheter has a wide range of motion and includes a mechanism, similar to the capstan on a sailboat, that allows for slow and controlled deployment.
“When you have a really nice, compact valve, you need to drop it on a dime,” the CEO said. “You need to be able to be very precise in how you're placing it, and that's what cascaded through to all of the capability in our catheter, and then the robot to deliver it.”
The single-arm robot mounts to the surgical table to provide control in navigating the valve placement. “It’s an incredibly simple robot," said Nixon, who spent more than 20 years as an executive at robotics pioneer Intuitive Surgical. “The stability there makes a difference because, remember, we’re operating in a beating heart.”
Capstan’s first procedures were performed at Hospital Clínico Universidad Católica in Santiago, Chile.
“Both patients had elimination of their mitral regurgitation, with unobstructed left ventricular outflow tracts, and were released home after a few days feeling much better than how they arrived,” Santiago Garcia, director of the structural heart program at The Christ Hospital in Cincinnati, Ohio, said in a statement. “This is the enabling technology the structural heart field has been waiting for.” Garcia assisted with the procedures.
Capstan is backed by $110 million from its latest funding round, whose investors include Intuitive Ventures. Nixon said the company is working toward a pivotal trial from which it will make an FDA submission with the goal of bringing its valve system to market in 2028.
