CardioKinetix's Parachute ventricular partitioning device has showed positive data in the treatment of ischemic heart failure in a German sub-study of the Parachute Cohort B trial.
The Parachute is a catheter based partitioning device featuring a fluoropolymer (ePTFE) membrane stretched over a nitinol frame, placed 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, which reduces the overall volume and restores normal geometry and function in the left ventricle.
The Parachute trial is a dual-arm (Parachute vs. Optimal Medical Therapy) open-label multicentre registry is intended to assess the Parachute implant in ischemic heart failure patients in 14 centres across Europe.
The trial enrolled 19 patients in Cohort A and will enrol up to 80 patients in Cohort B, to evaluate device related major adverse cardiac events (MACE) at six months, hemodynamic measures by echocardiography (ECHO) and imaging measures by computed tomography (CT).
At three months, the trial showed 18% ejection fraction (EF) improvement, 62% six minute walk improvement, 14% reductions in left ventricular end-diastolic volume (LVEDV) and left ventricular end-systolic volume (LVESV), plus a 17% reduction in ProBNP, a diagnostic marker evaluating the severity of heart failure.
University Hospital Rostock, Germany, professor of medicine Hüseyin Ince said after the implant of the Parachute, heart failure patients showed considerable improvement in symptom scores and quality of life.
"Early studies suggest that by reducing volume and restoring a more normal geometry and function to the left ventricle, we can arrest the progression of heart failure, reduce mortality and improve quality of life," Ince added.
CardioKinetix Clinical Affairs vice president Thomas Engels said in all previous studies the company observed similar improvements in treated heart failure patients.
"We look forward to collecting additional data on the Parachute as we begin our early commercialisation efforts in Europe and start our pivotal trial in the United States," Engels added.