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: Not yet available

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? The Berlin Heart EXCOR® Pediatric VAD U.S. clinical trial demonstrated that approximately 65% EXCOR® Pediatric VAD patients survived to cardiac transplantation or were successfully weaned from the device (since their hearts recovered). Of the 65% of patients, greater than 70% were transplanted or weaned with either no neurologic events or a good neurologic outcome.

When should it not be used? The device should not be implanted in patients with implanted artificial aortic valves due to an increased risk of blood clots. Additionally, patients who cannot tolerate medicines that stop blood from clotting should not be implanted with the EXCOR® Pediatric VAD.

Additional information: Summary of Safety and Probable Benefit and labeling will be available soon.

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