The Parachute is a catheter based partitioning device featuring a fluoropolymer (ePTFE) membrane stretched over a nitinol frame.
It is 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.
Parachute trial is a dual-arm (Parachute vs. Optimal Medical Therapy) open-label multi-centre registry that is intended to assess the Parachute implant in ischemic heart failure patients in 14 centres across Europe, and it enrolled 19 patients in Cohort A and will enroll up to 80 patients in Cohort B.
CardioKinetix Clinical Affairs vice president Thomas Engels said in all the previous studies the company has observed similar improvements in treated heart failure patients.
"We look forward to collecting additional data on the Parachute as we begin our early commercialization efforts in Europe and start our pivotal trial in the United States," Engels added.
