The PARACHUTE^TM Procedure

The PARACHUTE^TM procedure intends to address heart failure patients who have developed left-sided heart failure following a Myocardial Infarction (MI) heart attack. MI typically damages the heart muscle, due to lack of blood supply to the region during heart attack.

After MI many HF patients experience enlargement of their left ventricle causing a decrease in cardiac output resulting in heart failure symptoms such as shortness of breath. The PARACHUTE^TM partitions the damaged muscle, isolating the non-functional muscle segment from the functional segment, and decreases the overall volume.

CardioKinetix, Inc. has developed a percutaneous treatment for patients with left ventricular dilation after an anterior MI. The implantable device, called the PARACHUTE^TM is a partitioning membrane deployed within the compromised ventricle. The PARACHUTE^TM isolates the dysfunctional region of the ventricle and decreases chamber volume, thereby increasing cardiac output. Options for patients whose ventricle has enlarged are limited, with most on medical therapy and/or a cardiac resynchronization device that only benefits heart failure patients with a specific EKG pattern.

The PARACHUTE^TM procedure is performed in the cardiac catheterization lab or surgical suite, with the patient receiving local anesthesia . Under imaging guidance, the physician inserts the self-attaching PARACHUTE^TM device through the femoral artery, and deploys it into the apex of the left ventricle. The PARACHUTE^TM device partitions off the portion of the ventricle affected by the damaged myocardium, reducing the volume of the ventricle by approximately 20%, and reshapes the ventricle to a more natural conical shape. The reduced volume reduces wall stress and increases contractility and ejection fraction (a measure of the effectiveness of the ventricle).

The PARACHUTE^TM device, implanted by an Interventional Cardiologist, has demonstrated in feasibility trials that patients experience a significant decrease in heart failure symptoms and an increase in exercise capacity and quality of life; with virtually no device related safety events. The feasibility trial also established that the device can be implanted with ease by interventional cardiologists under local anesthesia, with patients discharged in twenty-four hours.

The PARACHUTE^TM device, which looks like an inverted parachute, is comprised of an synthetic fluoropolymer (ePTFE) membrane stretched over a nitinol frame. The self attaching device is inserted and deployed into the apex of the left ventricle via the femoral artery and partitions off the portion of the ventricle affected by the damaged myocardium, reducing the volume of the ventricle by approximately 20% and reshapes the ventricle to a more natural conical shape. The reduced volume reduces wall stress and increases contractility and ejection fraction (a measure of the effectiveness of the ventricle).