CardioKinetix has obtained CE mark approval for two additional sizes of its Parachute Ventricular Partitioning Device (Parachute) implant.
The Parachute comprises a synthetic fluoropolymer (ePTFE) membrane stretched over a nitinol frame which is deployed within the left ventricle for patients who have developed ischemic heart failure following a heart attack.
The Parachute implant partitions the damaged muscle, isolating the non-functional muscle segment from the functional segment, thus decreasing the overall volume and restores a more normal geometry and function in the left ventricle.
Parachute’s CE Mark approval was supported by data from both the Parachute clinical trial and Parachute US feasibility trial.
The dual-arm, open-label, multi-center registry clinical trial met the primary endpoint including device related major adverse cardiac events (MACE) at 6 months.
The trial aslo met other key endpoints including hemodynamic measures by echocardiography (ECHO) and imaging measures by computed tomography (CT).
CardioKinetix president and CEO Wes Johnson said these approvals will support their early commercialization efforts in select European markets through their Parachute III clinical trial.