Menlo Park, CA – CardioKinetix Inc., a medical device company that has developed a novel transcatheter implant called the Parachute™ Ventricular Partitioning Device (Parachute™), announced today that the first patients in Portugal, Latvia, Slovenia and the United Kingdom have been treated with the Parachute™ implant as part of the PARACHUTE clinical trial. Up to 80 patients are currently being enrolled in the second cohort of the PARACHUTE trial in 14 centers across Europe and the Company expects that enrollment will be completed in 2012.
After a heart attack, many heart failure patients experience enlargement of their left ventricle causing a decrease in cardiac output resulting in heart failure symptoms such as shortness of breath. Treatment options for patients whose ventricle has enlarged are limited. 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. In clinical studies to date, the Parachute™ has been shown to stop the progression of heart failure, reduce mortality, and improve quality of life.
“The expansion of the PARACHUTE trial into these four new markets, in addition to the Parachute™ implants already completed in Germany and Serbia, will broaden physicians’ exposure to the Parachute™ implant in the European Union,” said Wes Johnson, President and CEO of CardioKinetix Inc. “Enrollments in other key European countries are expected in the coming months. We are pleased with the interest shown in the trial to date and encouraged by the current pace of enrollment”.
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.
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).
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.