Shots:
- HighLife received CE Mark approval for its HighLife Clarity Mitral Heart Valve for use with HighLife TMVR System for adults with symptomatic mod. to sev. or sev. mitral valve regurgitation (MR) who are unsuitable for surgery or transcatheter edge-to-edge repair
- Four-year follow-up of the first 35 consecutively treated pts showed durable valve performance, with sustained MR reduction & stable mean gradients, & no reported valve thrombosis, LVOT obstruction, hemolysis or percutaneous PVL closure
- Mean HighLife valve gradients remained low & stable at 4yrs. (4.7 mmHg), with limited additional HF hospitalizations between 2 & 4yrs. & no increase in surgery or reintervention after yr. 1; Clarity Valve will be studied in a US trial starting Q3’26
Ref: Globenewswire | Image: HighLife | Press Release
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