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CSU innovation receives FDA approval for heart valve technology

How Dr. Christopher Orton’s innovation made it from whiteboard to market
  • July 2025
  • CSU Strata Staff
Physician holding a pen gestures toward anatomical heart model during a consultation.
What began as a whiteboard sketch by Christopher Orton, a Professor in the Department of Clinical Sciences at CSU, evolved into the FDA-approved Tendyne™ Transcatheter Mitral Valve Replacement system.

In 2009, Christopher Orton, professor in the Department of Clinical Sciences at CSU, disclosed a technology to CSU Strata: a “System and Device for Transcatheter Mitral Valve Replacement.” The idea began on a whiteboard, as Orton and collaborator Kemal Schankereli brainstormed ways to address valvular heart disease (VHD), one of the most common and deadly conditions in humans and dogs.

Orton’s early research aimed to develop a less invasive way to replace the mitral valve—a crucial part of the heart responsible for regulating blood flow from the left atrium to the left ventricle while preventing backflow. Orton focused his research on dogs, but there were clear applications for human health. Recognizing the potential, he worked with CSU Strata to secure patent protection for the invention, paving the way for commercial development.

Early commercialization of the technology was led by Avalon and Tendyne Holdings, with Tendyne advancing the technology for human use. Abbott, a global healthcare leader developing and delivering advanced medical technologies, then acquired the licensed technology. The concept became the foundation for what is now known as the Tendyne™ Transcatheter Mitral Valve Replacement (TMVR) system. Before gaining US FDA approval, the device earned a CE mark, a certification indicating that the product meets European Union standards for health, safety, and environmental protection, allowing it to be marketed across Europe. This milestone demonstrated the innovation’s global potential and validated its readiness for clinical use. Most recently, Abbott announced FDA approval of the Tendyne™ TMVR system to treat people suffering from severe mitral annular calcification (MAC)—a condition caused by calcium buildup in the ring-like structure that supports the mitral valve, which can severely impair the heart’s ability to pump blood effectively and lead to symptoms such as shortness of breath, chest pain, and dizziness.

Patients with severe MAC often have mitral valves that are leaky (known as mitral regurgitation, where the blood flows backwards through the valve), or narrowed (known as stenosis, which restricts blood flow through the heart). These patients are often considered too high-risk for open-heart surgery or mitral repair with existing devices like MitraClip™. Tendyne™ provides these patients with a minimally invasive alternative delivered through a small incision in the chest. The self-expanding, repositionable valve is available in multiple sizes to fit diverse anatomies and bridge a critical treatment gap.

As a leading authority in veterinary cardiovascular surgery and recipient of CSU Strata’s 2020 Innovative Excellence Award, Orton reflected on the significance of this achievement.

“I’ve learned that if you have an idea, write it down and document it,” Orton said. “Realize from day one that it might be pretty darn good—send it to CSU Strata to submit a provisional patent, and who knows where it will go?”

“Seeing the impact of this innovation is why CSU Strata and the field of technology transfer are so important,” said Steve Foster, director of licensing at CSU Strata. “Being part of an ecosystem where ideas are turned into products that benefit society cannot be emphasized enough. We are excited to see how patients will benefit from the Tendyne TMVR system.”

The success of the Tendyne™ device underscores the critical role of technology transfer at CSU, transforming innovative ideas into real-world impact. CSU Strata plays a key role in guiding researchers through the process to ensure that the university’s innovations reach the people who need them most.

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