FIH Implantation of Sutra Hemi-Valve TMVR System Performed in New Zealand

September 8, 2025—Sutra Medical, Inc. announced the successful first-in-human (FIH) implantation of the company’s Sutra Hemi-valve transcatheter mitral valve repair system, which was performed at Waikato Hospital in Hamilton, New Zealand.

The company stated that its flagship Sutra Hemi-valve is a posterior leaflet replacement technology designed to restore mitral valve function without obstructing the left ventricular outflow tract and to broaden access to mitral valve repair across diverse anatomies and risks.

The company advised that the Sutra Hemi-valve is an investigational device and not approved for commercial use. The procedure was performed under an FIH clinical protocol approved by the New Zealand Health and Disability Ethics Committee.

According to Sutra Medical, the FIH procedure was performed on a high-risk patient (age, 83 years) with severe (4+) functional mitral regurgitation (MR) and posterior leaflet tethering—a condition unsuitable for surgery or transcatheter edge-to-edge repair, noted the company.

Using Sutra’s transfemoral, trans-septal delivery system, the Sutra Hemi-valve reduced MR from severe to trace–mild and the patient recovered well and was discharged on day 3, reported the company.

The implantation team was led by Sanjeevan Pasupati, MBChB, who is Director of Structural Heart Disease & Cardiovascular Research at Waikato Hospital.

“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,” commented Dr. Pasupati in the company’s press release. “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.”