The European commission has granted extended CE Mark approval for two additional sizes of CardioKinetix's Parachute ventricular partitioning device, used to treat patients with heart failure resulting from a heart attack.
The Parachute is a catheter based partitioning device implanted within the left ventricle for patients who have developed ischemic heart failure following a heart attack. The implant partitions the damaged muscle, isolating the non-functional muscle segment from the functional segment, minimising the overall volume and restoring normal geometry and function in the left ventricle.
The Parachute ventricular partitioning device features a synthetic fluoropolymer (ePTFE) membrane stretched over a nitinol frame, and approval of the device is supported by data from both the Parachute clinical trial and Parachute US feasibility trial.
The Parachute is a dual-arm (Parachute vs Optimal Medical Therapy) open-label multicentre registry which enrolled 19 patients in Cohort A and will enroll up to 80 patients in Cohort B.
Trials are designed to assess the Parachute implant in ischemic heart failure patients with study endpoints including device related major adverse cardiac events (MACE) at six months, hemodynamic measures by echocardiography (ECHO) and imaging measures by computed tomography (CT).
The company is commencing the Parachute III clinical trial for supporting the development of post market clinical data and will allow physicians in the European Union to increase their experience with the technology while continuing to develop the therapy.
The dual-arm open-label multicentre Parachute III of the Parachute implant will enroll up to 100 patients with ischemic heart failure in up to 20 centres in Europe.
The primary objective of the Parachute III trial is procedural and device related MACE through 60 months, hemodynamic measures by echocardiography and imaging measures by CT.
CardioKinetix president and CEO Wes Johnson said the approval will support the company's early commercialisation efforts in select European markets.
In earlier clinical studies, the Parachute implant has been shown to suppress the progression of heart failure, reduce mortality and improve quality of life.