CardioKinetix, a medical device company that has developed a novel transcatheter implant called the Parachute Ventricular Partitioning Device, announced that a German sub-study from the PARACHUTE Cohort B trial continued to show positive results after heart failure patients were treated with the Parachute device. The results were presented by Huseyin Ince, professor of Medicine, University Hospital Rostock, Germany, during the 27th annual Interventional Cardiology conference in Snowmass Village, USA.
When implanted in the left ventricle, the Parachute implant partitions 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. The sub-study presented data on eight of the 80 patients to be enrolled in Cohort B of the ongoing PARACHUTE trial. The average patient studied was 62 years of age, had an NYHA class of 2.8, and an ejection fraction of 28% at baseline.
At three months meaningful improvements were shown in the following critical measurements:
- One full New York Heart Association (NYHA) class improvement (2.8 at baseline vs. 1.6 at three months, p<0.05)
- 18% ejection fraction improvement (28% at baseline vs. 33% at three months, p<0.05)
- 62% six-minute walk improvement (305 meters vs. 495 meters, p<0.05)
- 14% reduction in left ventricular end-diastolic volume (LVEDV) and left ventricular end-systolic volume (LVESV) reduction (LVEDV: 220ml at baseline vs. 190ml at three months, p
- 17% reduction in ProBNP, a diagnostic marker evaluating the severity of heart failure (850pg/ml at baseline vs. 702pg/ml at three months, p<0.05)
“After the implant of the Parachute, my heart failure patients showed significant improvement in their symptom scores and quality of life,” said Huseyin Ince. “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.”
“We continue to be encouraged by the early clinical results demonstrated by the Parachute implant. In all of our previous studies we have seen similar improvements in treated heart failure patients,” said Thomas Engels, vice president of Clinical Affairs of CardioKinetix. “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.”