The Industry

Cardiovascular devices are a $12.8 billion global industry that is growing at a rate of 12 percent per year. By 2006, the industry is expected to be at $22.8 billion. In addition, the projected market size for micro-medical biofeedback sensors is $10 billion this year. Together, heart assist devices and biofeedback sensors are one of the largest and most rapidly growing sectors in the economy. Here is an overview of the industry devices for heart failure patients:

Replacement Mechanical Hearts: Complex, motor-driven, pulsatile blood pumps that are electrically powered (internal battery) and fully implantable and can take over the functioning of both ventricles after the natural heart is removed.

Pulsatile Ventricular Assist Devices: Electrically powered blood pumps attached to the natural heart to augment its pumping capacity and, in effect, take over the work of the native left ventricle. These pumps can allow the heart to recover and the device to be removed or allow the patient to get stronger while waiting for a suitable donor heart to become available (cardiac transplantation).

Continuous-Flow Ventricular Assist Devices, also called Axial Flow Pumps: Very small blood pumps (3 inches by 1 inch in some types) that work by a magnetic impeller that rotates at incredible speeds and causes the continuous flow of blood. These heart assist devices can allow the patient to recover or to wait for a suitable donor heart to become available.

Intra-Aortic Balloon Pumps: Small balloons placed in the aorta via a catheter inserted in a leg artery. The balloon augments the blood flow by sequentially inflating and deflating. These pumps are used temporarily until a heart assist device or a replacement heart is implanted or until the natural heart recovers adequate function.

Biofeedback sensors: Microscopic medical sensors that can be embedded in human tissue and in smart bio-adaptive heart devices to measure blood pressure, blood flow, oxygen saturation, or other physiologic variables. The bioengineering goal is to build microsensors to function as internal controls and diagnostics for at least five years (180 million heart beats) without having to be surgically removed. Microsensors will enable bio-adaptive heart innovations to deliver data on the functioning of the device continuously and to make adjustments in device performance automatically, without alarming the patient. The data generated by the biofeedback sensors will be converted to diagnostic information available to the patient and to the physician and will further advance medical research and improve quality of life for patients.

Other Bio-Adaptive Heart Innovations:
The Institute may also be involved in the development and testing of other related bio-adaptive heart innovations such as pacemakers, replacement heart valves, vascular grafts, monitoring sensors, diagnostic equipment, computer programs to run automated medical devices, surgical procedures, implantable cardiac defibrillators, surgical instruments, and wearable computers to help manage patient information.