Sutra Medical, Inc.  announced the world’s first successful first-in-human (FIH) implantation of its Sutra Hemi-valve Transcatheter Mitral Valve Repair System at Waikato Hospital in New Zealand.

The procedure was performed on an 83-year-old high-risk patient with severe (4+) functional mitral regurgitation (MR) and posterior leaflet tethering, a condition unsuitable for surgery or transcatheter edge-to-edge repair. Using Sutra’s transfemoral, trans-septal delivery system, the Sutra Hemi-valve reduced MR from severe to trace–mild. The patient recovered well and was discharged on day 3.

The implantation was led by Dr. Sanjeevan Pasupati, Director of Structural Heart Disease & Cardiovascular Research at Waikato Hospital, with Dr. Pranesh Jogia, Dr. Faeez Mohamad Ali, Dr. Preeti Gahlan, Dr. Francesco Pirone, Dr. Scott Robinson, and Ms. Simi Christudas Jayakumari.

“Partnering with Sutra Medical enables us to bring new minimally-invasive treatment options to patients and address the current unmet need in transcatheter mitral valve therapies,” said Dr. Pasupati. “The combination of Sutra’s device design and advanced pre-operative imaging analysis enabled optimal implant placement and excellent coaptation with the native anterior leaflet.”

“The first-in-human implantation of the Sutra Hemi-valve is a transformative advance for patients with severe MR who currently have limited or no treatment options,” said Dr. Wei Sun, CEO of Sutra Medical. “We are deeply grateful to the outstanding New Zealand clinical team for their expertise and commitment to advancing care for high-risk patients.”

The Sutra Hemi-valve™ is a novel posterior leaflet replacement technology designed to restore mitral valve function without obstructing the left ventricular outflow tract. With over 23 million patients worldwide affected by MR, this milestone represents a major step toward expanding access to life-saving therapies.