Capstan has developed a catheter-based treatment for cardiac valve replacements. Source: Capstan Medical
Capstan Medical today said it has successfully completed its first in-human, robot-assisted transcatheter mitral valve replacements. The Santa Cruz, Calif.-based company claimed that it was “the first time a minimally invasive robotic structural heart platform has been used in clinical practice, successfully delivering a novel mitral valve into two human patients.”
Dr. Gonzalo Martinez performed the minimally invasive procedures at Hospital Clínico Universidad Católica in Santiago, Chile. Martinez, M.D., MPhil, is director of the Endovascular Therapy Center at Pontifical Catholic University of Chile. He was supported by Dr. Santiago Garcia, director of the Structural Heart Program at The Christ Hospital in Cincinnati, Ohio.
“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,” said Martinez. “The Capstan technology exceeded our expectations even in these early cases.”
New cardiac options could treat more patients
Heart disease remains the leading cause of death in the world, claiming a life every 33 seconds in the U.S. alone, according to the Centers for Disease Control. Today, more than 7 million people in the U.S. have heart valve disease, a complex condition made up primarily of dysfunctional mitral and tricuspid valves.
Current treatment options, typically by open-heart surgery, are not viable for most patients, and existing catheter-based options have high rates of patient exclusion, said Capstan Medical. The company said it seeks to overcome current treatment limitations by bringing together novel heart-valve implants and advanced catheter technology, fully enabled through a robotic platform, to treat a broader set of patients.
“These successful first-in-human cases represent a significant leap forward in structural heart intervention,” said Garcia. “I’ve worked with numerous technologies, but this fundamentally changes what’s possible in the treatment of valvular heart disease.”
“The robotic platform provided unprecedented catheter stability and control, achieving optimal implant positioning,” he added. “Both patients had elimination of their mitral regurgitation, with unobstructed left ventricular outflow tracts. [They] were released home after a few days feeling much better than how they arrived. This is the enabling technology the structural heart field has been waiting for.“
Now accepting session submissions!
Capstan Medical continues on plan
Founded in 2020, Capstan Medical said it “is creating a new standard for minimally invasive, heart valve intervention.” The company is developing a suite of next-generation heart valve implants and a first-of-its-kind catheter-based robotic delivery platform.
Capstan raised $110 million in Series C funding in December 2024. It said it plans to continue to execute on its plan for clinical and development work leading to upcoming trials.
“Today marks a pivotal moment in the evolution of structural heart therapy,” said Maggie Nixon, CEO of Capstan Medical. “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.”
Tell Us What You Think!