CardioKinetix announced that it has received CE mark approval for two additional sizes of the Parachute ventricular partitioning device.
The Parachute is a catheter based partitioning device deployed within the left ventricle for patients who have developed ischaemic heart failure following a heart attack. This implant partitions the damaged muscle, isolating the non-functional muscle segment from the functional segment, which decreases the overall volume and restores a more normal geometry and function in the left ventricle.
In clinical studies to date, the Parachute implant has shown to stop the progression of heart failure, reduce mortality, and improve quality of life.
“We are pleased to have received additional CE mark approvals for the Parachute implant, and are enthusiastic about introducing the Parachute to treat heart failure patients in the European Union,” said Wes Johnson, president and CEO, CardioKinetix. “These approvals will support our early commercialisation efforts in select European markets through our PARACHUTE III clinical trial.”
CE mark approval for the Parachute in Europe was supported by data from both the PARACHUTE clinical trial and PARACHUTE US feasibility trial. To support the development of post market clinical data, the company is initiating the PARACHUTE III clinical trial. This trial will enable physicians in the European Union to increase their experience with the technology while continuing to develop the therapy.
About the PARACHUTE trial
PARACHUTE is a dual-arm (Parachute vs. optimal medical therapy), open-label, multicentre registry designed to evaluate the Parachute implant in ischaemic heart failure patients in 14 centres across Europe. The PARACHUTE trial enrolled 19 patients in Cohort A and will enrol up to 80 patients in Cohort B. The primary endpoint of the trial is device related major adverse cardiac events at 6 months. Other key endpoints include: haemodynamic measures by echocardiography and imaging measures by computed tomography.
About the PARACHUTE III trial
PARACHUTE III is a dual-arm (Parachute vs. optical medical therapy), open-label, multicentre registry, using CE marked product, designed to evaluate the Parachute implant. The trial will enroll up to 100 patients with ischaemic heart failure in up to 20 centres in Europe. The primary endpoint of the trial is procedural and device related major adverse cardiac events through 60 months. Other key endpoints include: haemodynamic measures by echocardiography and imaging measures by computed tomography.
