The company said it has treated 82 patients to date with the transapical (TA) Tiara mitral valve repair device. After reviewing the clinical data from its Tiara I and Tiara II studies, Neovasc believes there is sufficient evidence to support CE Mark approval.
Neovasc said in a news release that its next-generation transfemoral/trans-septal (TF/TS) Tiara design has been frozen as the company is on track for clinical trials and a first-in-human implant by the end of 2020.
The TF/TS Tiara consists of a “D-shape” to mimic the native anatomy and is designed to avoid left ventricular outflow tract (LVOT) obstruction. It also includes full retrievability of the device after the atrial and ventricular portions of the valve have been deployed until the final point of release to reduce implant risk for the patient.