Lake Forest, CA – August 31, 2025 – Sutra Medical, Inc. today 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 complex condition unsuitable for conventional surgical repair or transcatheter edge-to-edge approaches. Using Sutra’s proprietary transfemoral, trans-septal delivery system, the Sutra Hemi-valve was successfully implanted, reducing MR from severe to trace–mild. The patient recovered well and was discharged from the hospital on day 3.
The implantation was carried out by Waikato Hospital structural heart team, led by Dr. Sanjeevan Pasupati, Director of Structural Heart Disease & Cardiovascular Research, along 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 that restores mitral valve function by coapting seamlessly with the native anterior leaflet, eliminating MR without obstructing left ventricular outflow tract. Unlike conventional surgery and current transcatheter devices, the Sutra Hemi-valve is designed to address anatomical limitations that prevent many MR patients from receiving effective treatment. With approximately 23 million people affected worldwide, MR remains a significant unmet medical need. The Sutra Hemi-valve has the potential to expand access to care for millions of underserved patients globally.
About Sutra Medical
Sutra Medical, Inc. is a cardiovascular device company pioneering next-generation solutions for structural heart disease. Its flagship Sutra Hemi-valve is designed to broaden access to effective mitral valve repair across a wide spectrum of patient anatomies and surgical risks. The company is headquartered in Lake Forest, California. More information at www.sutramedical.com
Media Contact:
Dr. Caitlin Martin
cmartin@sutramedical.com | +1 (949) 317-3672
Disclaimer
The procedure was performed under a first-in-human clinical protocol approved by the New Zealand Health and Disability Ethics Committee (HDEC). The Sutra Hemi-valve is an investigational device and not approved for commercial use in any geography.