Capstan Medical Conducts First Robotic-Assisted Transcatheter Mitral Valve Replacements

Capstan Medical has conducted the first-in-human robotic assisted transcatheter mitral valve replacements. The procedures mark the first time a minimally invasive robotic structural heart platform has been used in clinical practice, successfully delivering a novel mitral valve into two patients. 

The landmark minimally invasive procedures were performed at Hospital Clínico Universidad Católica in Santiago Chile, by Dr. Gonzalo Martinez, director of the Endovascular Therapy Center at Pontifical Catholic University of Chile. Dr. Santiago Garcia, director of the Structural Heart Program at The Christ Hospital in Cincinnati, Ohio, supported the cases. 

“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,” Dr. Martinez said. “The Capstan technology exceeded our expectations even in these early cases.”

Heart disease remains the leading cause of death in the world, claiming a life every 33 seconds in the United States alone. There are currently more than 7 million people in the United States with 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. Capstan’s minimally invasive solution seeks to overcome limitations of current treatment options 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. I’ve worked with numerous technologies, but this fundamentally changes what’s possible in the treatment of valvular heart disease,” Dr. Garcia stated. “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 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.“

Following its $110 million Series C funding, Capstan will continue to execute on its plan for clinical and development work leading to upcoming pivotal trials.  

“This marks a pivotal moment in the evolution of structural heart therapy,” Capstan Medical CEO Maggie Nixon stated. “Seeing the capabilities of our system, catheter, and implant come together to deliver groundbreaking human cases validates years of research, development, and commitment from our team. This achievement demonstrates the potential of our technology to reshape the future of structural heart procedures.”

Founded in 2020, Capstan Medical is developing a suite of next-generation heart valve implants and a first-of-its-kind catheter-based robotic delivery platform.