Berlin Heart EXCOR® Pediatric Ventricular Assist Device (VAD) - H100004
Product Name: EXCOR® Pediatric Ventricular Assist Device (VAD)
PMA Applicant: Berlin Heart, GmbH
Address: 200 Valleywood Suite A500, The Woodlands, TX 77382
Approval Date: December 16, 2011
Approval Letter: http://www.accessdata.fda.gov/ cdrh_docs/pdf10/h100004a.pdf
What is it? The EXCOR® Pediatric VAD is a blood pump that vibrates rhythmically and is designed to assist patients who cannot pump enough blood with their own natural heart. The device can be used in patients who cannot effectively pump blood with their left and/or right ventricle. The VAD device consists of one or two air-driven blood pumps (depending on single-ventricle or double-ventricle support), small tubes inserted into the body that are used to connect the blood pumps to the atrium or ventricle and to the great arteries, and the IKUS driving unit. The IKUS provides air pulses that drive the rhythm of the pumps and also has computer controls to be used by hospital staff.
How does it work? The EXCOR® Pediatric VAD does not entirely replace the natural function of the heart. Instead, it works along with the patient’s own heart to pump blood. In a healthy heart, the left ventricle pumps blood rich with oxygen (oxygenated) to the vital organs and the right ventricle pumps non-oxygenated blood to the lungs to obtain oxygen. In a heart weakened by heart failure, the left and/or right ventricles are not strong enough to pump blood sufficiently. The EXCOR® Pediatric VAD helps the heart by supporting the weak ventricles.
The blood pump interior is divided into an air chamber and a blood chamber by a flexible membrane. Air pressure provided by the IKUS driving unit causes the membrane inside the pump to inflate and deflate. The air pulse moves the membrane, thus allowing blood to enter and exit the device. Valves are located at the blood pump connection branches to ensure one-way directional blood flow. The pulse rate and pump pressures can all be monitored and adjusted on the IKUS driving unit by hospital staff.
When is it used? The EXCOR® Pediatric VAD is used when the natural heart is unable to maintain normal blood flows and/or pressure or if it cannot adequately provide oxygenated blood to the vital organs. It is intended to provide support to the heart while these pediatric patients await a heart transplant.
What will it accomplish? In the U.S clinical trial of a total of 48 patients, 43 out of the 48 patients (approximately 90%) survived to cardiac transplantation or were successfully taken off the device (because their hearts recovered). Of these 43 patients, 35 out of the 43 patients (greater than 70%) received a heart transplant or were taken off the device with either: a) no neurologic events (such as a clot blocking a blood vessel in the brain) or; b) neurologic events that resulted in good neurologic outcomes (no apparent effect on normal brain function as a result of an event such as a clot blocking a blood vessel in the brain).
When should it not be used? The device should not be implanted in patients who may undergo an MRI (magnetic resonance imaging). Additionally, patients who cannot take medicines that stop blood from clotting should not be implanted with the EXCOR® Pediatric VAD.
Additional information: The Summary of Safety and Probable Benefit and labeling are available online.