A percutaneous lead assembly for an active implantable device, the lead assembly comprising a sheath with a plurality of wires extending from a proximal end to a distal end. The wires being adapted to power the active implantable device; the distal end having at least one electrode fixed thereon. The electrodes being in communication with sensor electronics and wherein at least one electrode is on the outer layer of the lead assembly in which the electrode is used to detect at least one of acceleration and electrical signals of an organ.

An implantable pump system is provided, suitable for use as a left ventricular assist device (LVAD) system, having an implantable pump, an extracorporeal battery and a controller coupled to the implantable pump, and a programmer selectively periodically coupled to the controller to configure and adjust operating parameters of the implantable pump. The implantable pump includes a flexible membrane coupled to an actuator assembly that is magnetically engagable with electromagnetic coils, so that when the electromagnetic coils are energized, the actuator assembly causes wavelike undulations to propagate along the flexible membrane to propel blood from through the implantable pump. The controller may be programmed by a programmer to operate at frequencies and duty cycles that mimic physiologic flow rates and pulsatility while operating in an efficient manner that avoids thrombus formation, hemolysis and/or platelet activation.

An implantable pump system is provided, suitable for use as a left ventricular assist device (LVAD) system, having an implantable pump, an extracorporeal battery and a controller coupled to the implantable pump, and a programmer selectively periodically coupled to the controller to configure and adjust operating parameters of the implantable pump. The implantable pump includes a flexible membrane coupled to an actuator assembly that is magnetically engagable with electromagnetic coils, so that when the electromagnetic coils are energized, the actuator assembly causes wavelike undulations to propagate along the flexible membrane to propel blood from through the implantable pump. The controller may be programmed by a programmer to operate at frequencies and duty cycles that mimic physiologic flow rates and pulsatility while operating in an efficient manner that avoids thrombus formation, hemolysis and/or platelet activation.

A device for reducing pressure within a lumen includes a reservoir structured for holding a fluid therein, an injection port in fluid communication with the reservoir, a compliant body structured to expand and contract upon changes in pressure, and a conduit extending between and fluidly coupling the reservoir and the compliant body. The fluid may be a compressible or a noncompressible fluid.

A control device (100) for controlling the rotational speed (n.sub.VAD(t)) of a non-pulsatile ventricular assist device, VAD, (50) uses an event-based within-a-beat control strategy, wherein the control device is configured to alter the rotational speed of the VAD within the cardiac cycle of the assisted heart and to synchronize the alteration of the rotational speed with the heartbeat by at least one sequence of trigger signals (σ(t)) that is related to at least one predetermined characteristic event in the cardiac cycle. Further, a VAD (50) for assistance of a heart comprises the control device (100) for controlling the VAD, wherein the VAD is preferably a non-pulsatile rotational, for example catheter-based, blood pump.

A control device (100) for controlling the rotational speed (n.sub.VAD(t)) of a non-pulsatile ventricular assist device, VAD, (50) uses an event-based within-a-beat control strategy, wherein the control device is configured to alter the rotational speed of the VAD within the cardiac cycle of the assisted heart and to synchronize the alteration of the rotational speed with the heartbeat by at least one sequence of trigger signals (σ(t)) that is related to at least one predetermined characteristic event in the cardiac cycle. Further, a VAD (50) for assistance of a heart comprises the control device (100) for controlling the VAD, wherein the VAD is preferably a non-pulsatile rotational, for example catheter-based, blood pump.

A hemodynamic flow assist device includes a miniature pump, a basket-like cage enclosing and supporting the pump, and a motor to drive the pump. The device is implanted and retrieved in a minimally invasive manner via percutaneous access to a patient's artery. The device has a first, collapsed configuration to assist in implantation and a second, expanded configuration once deployed and active. The device is deployed within a patient's aorta and is secured in place via a self-expanding cage which engages the inner wall of the aorta. The device includes a helical screw pump with self-expanding blades, sensors, and anchoring structures. Also disclosed is a retrieval device to remove the hemodynamic flow assist device once it is no longer needed by the patient and an arterial closure device to close the artery access point after implantation and removal of the hemodynamic flow assist device. The hemodynamic flow assist device helps to increase blood flow in patients suffering from congestive heart failure and awaiting heart transplant.

A cardiac assist device including a sleeve configured to externally wrap around a native, intact heart; a motor, and a drive shaft that connects the motor to the sleeve, wherein, actuation of the motor and the drive shaft provides a synchronized assisting force to a pumping force of the native, intact whole heart, thereby helping contraction and expansion of the heart located within an internal volume defined by the sleeve. Some embodiments relate to a system for synchronizing the cardiac assist device with a heart including the cardiac assist device; a power supply connected to the motor; and an electrical connector-relay configured to receive electrical signals from the pacemaker and to generate actuating signals that are relayed to the motor and the drive shaft, wherein, during operation of the system in a subject, the heart is assisted in contracting synchronously with the pacemaker signal rhythm.

A method of predicting an adverse event in a patient having an implantable blood pump including correlating a pulsatility value to a flow trough value associated with the blood pump to determine a flow peak value; dividing the determined flow peak value by a pump current to determine a pulsatility peak value; tracking a first moving average of the pulsatility peak value, the first moving average defining a threshold range; tracking a second moving average of the pulsatility peak value, the second moving average being faster than the first moving average; and generating an alert when the second moving average deviates from the threshold range.

A method of predicting an adverse event in a patient having an implantable blood pump including correlating a pulsatility value to a flow trough value associated with the blood pump to determine a flow peak value; dividing the determined flow peak value by a pump current to determine a pulsatility peak value; tracking a first moving average of the pulsatility peak value, the first moving average defining a threshold range; tracking a second moving average of the pulsatility peak value, the second moving average being faster than the first moving average; and generating an alert when the second moving average deviates from the threshold range.