CardioKinetix Inc. Demonstrates Positive Results in German Sub-Study Using the Parachute(TM) for Percutaneous Ventricular Restoration Therapy in the Treatment of Ischemic Heart Failure
Published: Mar 09, 2012
MENLO PARK, CA--(Marketwire - March 08, 2012) -
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 (EF) 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 3 months, p < 0.05)
- 18% ejection fraction (EF) improvement (28% at baseline vs. 33% at 3 months, p < 0.05)
- 62% 6 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: 220 ml at baseline vs. 190 ml at 3 months, p < 0.05; LVESV: 154 ml vs. 132 ml, p < 0.05)
- 17% reduction in ProBNP, a diagnostic marker evaluating the severity of heart failure (850 pg/ml at baseline vs. 702 pg/ml at 3 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 Dr. Hüseyin 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, Inc. "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."
About the Parachute™ Ventricular Partitioning Device
The Parachute™ is a catheter based partitioning device deployed 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 decreases the overall volume and restores a more normal geometry and function in the left ventricle.
The Parachute™ implant is comprised of a fluoropolymer (ePTFE) membrane stretched over a nitinol frame. The device is deployed into the apex of the left ventricle and partitions off the portion of the ventricle affected by the damaged myocardium in order to treat patients with ischemic heart failure.
About the PARACHUTE Trial
PARACHUTE is a dual-arm (Parachute™ vs. Optimal Medical Therapy), open-label, multi-center registry designed to evaluate the Parachute™ implant in ischemic heart failure patients in 14 centers across Europe. The PARACHUTE trial enrolled 19 patients in Cohort A and will enroll up to 80 patients in Cohort B. The primary endpoint of the trial is device related Major Adverse Cardiac Events (MACE) at 6 months. Other key endpoints include: hemodynamic measures by echocardiography (ECHO) and imaging measures by computed tomography (CT).
About CardioKinetix Inc.
CardioKinetix (www.cardiokinetix.com) has developed a novel transcatheter implant called the Parachute™ Ventricular Partitioning Device (Parachute™). The Parachute™ intends to treat heart failure resulting from a heart attack in patients worldwide by improving overall cardiac function.