Study on stable equilibrium of levitated impeller in rotary pump with passive magnetic bearings

It is widely acknowledged that the permanent maglev cannot achieve stable equilibrium; the authors have developed, however, a stable permanent maglev centrifugal blood pump. Permanent maglev needs no position detection and feedback control of the rotor, nevertheless the eccentric distance (ED) and vibration amplitude (VA) of the levitator have been measured to demonstrate the levitation and to investigate the factors affecting levitation. Permanent maglev centrifugal impeller pump has a rotor and a stator. The rotor is driven by stator coil and levitated by two passive magnetic bearings. The rotor position is measured by four Hall sensors, which are distributed evenly and peripherally on the end of the stator against the magnetic ring of the bearing on the rotor. The voltage differences of the sensors due to different distances between the sensors and the magnetic ring are converted into ED. The results verify that the rotor can be disaffiliated from the stator if the rotating speed and the flow rate of the pump are large enough, that is, the maximal ED will reduce to about half of the gap between the rotor and the stator. In addition, the gap between rotor and stator and the viscosity of the fluid to be pumped also affect levitation. The former has an optimal value of ≈ 2% of the radius of the rotor. For the latter, levitation stability is better with higher viscosity, meaning smaller ED and VA. The pressure to be pumped has no effect on levitation.     

Novel maglev pump with a combined magnetic bearing

The newly developed pump is a magnetically levitated centrifugal blood pump in which active and passive magnetic bearings are integrated to construct a durable ventricular assist device. The developed maglev centrifugal pump consists of an active magnetic bearing, a passive magnetic bearing, a levitated impeller, and a motor stator. The impeller is set between the active magnetic bearing and the motor stator. The active magnetic bearing uses four electromagnets to control the tilt and the axial position of the impeller. The radial movement of the levitated impeller is restricted with the passive stability dependent upon the top stator and the passive permanent magnetic bearing to reduce the energy consumption and the control system complexity. The top stator was designed based upon a magnetic field analysis to develop the maglev pump with sufficient passive stability in the radial direction. By implementing this analysis design, the oscillating amplitude of the impeller in the radial direction was cut in half when compared with the simple shape stator. This study concluded that the newly developed maglev centrifugal pump displayed excellent levitation performance and sufficient pump performance as a ventricular assist device.     

A novel permanent maglev rotary LVAD with passive magnetic bearings

It has been widely acknowledged that permanent maglev cannot achieve stability; however, the authors have discovered that stable permanent maglev is possible under the effect of a combination of passive magnetic and nonmagnetic forces. In addition, a rotary left ventricular assist device (LVAD) with passive magnetic bearings has been developed. It is a radially driven impeller pump, having a rotor and a stator. The rotor consists of driven magnets and impeller; the motor coil and pump housing form the stator. Two passive magnetic bearings counteract the attractive force between motor coil iron core and rotor magnets; the rotor thereafter can be disaffiliated from the stator and become levitated under the action of passive magnetic and haemodynamic forces. Because of the pressure difference between the outlet and the inlet of the pump, there is a small flow passing through the gap of rotor and stator, and then entering the lower pressure area along the central hole of the rotor. This small flow comes to a full washout of all blood contacting surfaces in the motor. Moreover, a decreased Bernoulli force in the larger gap with faster flow produces a centring force that leads to stable levitation of the rotor. Resultantly, neither mechanical wear nor thrombosis will occur in the pump. The rotor position detection reveals that the precondition of levitation is a high rotating speed (over 3250 rpm) and a high flow rate (over 1 l min(-1)). Haemodynamic tests with porcine blood indicate that the device as a LVAD requires a rotating speed between 3500 and 4000 rpm for producing a blood flow of 4 - 6 l min(-1) against 100 mmHg mean pressure head. The egg-sized device has a weight of 200 g and an O.D. of 40 mm at its largest point.     

A novel permanent maglev impeller TAH: most requirements on blood pumps have been satisfied

Based on the development of an impeller total artificial heart (TAH) (1987) and a permanent maglev (magnetic levitation) impeller pump (2002), as well as a patented magnetic bearing and magnetic spring (1996), a novel permanent maglev impeller TAH has been developed. The device consists of a rotor and a stator. The rotor is driven radially. Two impellers with different dimensions are fixed at both the ends of the rotor. The levitation of the rotor is achieved by using two permanent magnetic bearings, which have double function: radial bearing and axial spring. As the rotor rotates at a periodic changing speed, two pumps deliver the pulsatile flow synchronously. The volume balance between the two pumps is realized due to self-modulation property of the impeller pumps, without need for detection and control. Because the hemo-dynamic force acting on the left impeller is larger than that on the right impeller, and this force during systole is larger than that during diastole, the rotor reciprocates axially once a cycle. This is beneficial to prevent the thrombosis in the pump. Furthermore, a small flow via the gap between stator and rotor from left pump into right pump comes to a full washout in the motor and the pumps. Therefore, it seems neither mechanical wear nor thrombosis could occur. The previously developed prototype impeller TAH had demonstrated that it could operate in animal experiments indefinitely, if the bearing would not fail to work. Expectantly, this novel permanent magnetic levitation impeller TAH with simplicity, implantability, pulsatility, compatibility and durability has satisfied the most requirements on blood pumps and will have more extensive applications in experiments and clinics.     

A novel permanent maglev rotary LVAD with passive magnetic bearings

It has been widely acknowledged that permanent maglev cannot achieve stability; however, the authors have discovered that stable permanent maglev is possible under the effect of a combination of passive magnetic and nonmagnetic forces. In addition, a rotary left ventricular assist device (LVAD) with passive magnetic bearings has been developed. It is a radially driven impeller pump, having a rotor and a stator. The rotor consists of driven magnets and impeller; the motor coil and pump housing form the stator. Two passive magnetic bearings counteract the attractive force between motor coil iron core and rotor magnets; the rotor thereafter can be disaffiliated from the stator and become levitated under the action of passive magnetic and haemodynamic forces. Because of the pressure difference between the outlet and the inlet of the pump, there is a small flow passing through the gap of rotor and stator, and then entering the lower pressure area along the central hole of the rotor. This small flow comes to a full washout of all blood contacting surfaces in the motor. Moreover, a decreased Bernoulli force in the larger gap with faster flow produces a centring force that leads to stable levitation of the rotor. Resultantly, neither mechanical wear nor thrombosis will occur in the pump. The rotor position detection reveals that the precondition of levitation is a high rotating speed (over 3250 rpm) and a high flow rate (over 1?l min^?1). Haemodynamic tests with porcine blood indicate that the device as a LVAD requires a rotating speed between 3500 and 4000 rpm for producing a blood flow of 4?–?6?l min^?1 against 100?mmHg mean pressure head. The egg-sized device has a weight of 200?g and an O.D. of 40?mm at its largest point.     

New concepts and new design of permanent maglev rotary artificial heart blood pumps

According to tradition, permanent maglev cannot achieve stable equilibrium. The authors have developed, to the contrary, two stable permanent maglev impeller blood pumps. The first pump is an axially driven uni-ventricular assist pump, in which the rotor with impeller is radially supported by two passive magnetic bearings, but has one point contact with the stator axially at standstill. As the pump raises its rotating speed, the increasing hydrodynamic force of fluid acting on the impeller will make the rotor taking off from contacting point and disaffiliate from the stator. Then the rotor becomes fully suspended. The second pump is a radially driven bi-ventricular assist pump, i.e., an impeller total artificial heart. Its rotor with two impellers on both ends is supported by two passive magnetic bearings, which counteract the attractive force between rotor magnets and stator coil iron core. The rotor is affiliated to the stator radially at standstill and becomes levitated during rotation. Therefore, the rotor keeps concentric with stator during rotation but eccentric at standstill, as is confirmed by rotor position detection with Honeywell sensors. It concludes that the permanent maglev needs action of a non-magnetic force to achieve stability but a rotating magnetic levitator with high speed and large inertia can maintain its stability merely with passive magnetic bearings.     

Permanent magnetic-levitation of rotating impeller: a decisive breakthrough in the centrifugal pump

Magnetic bearings have no mechanical contact between the rotor and stator, and a rotary pump with magnetic bearings therefore has no mechanical wear and thrombosis. The magnetic bearings available, however, contain electromagnets, are complicated to control and have high energy consumption. Therefore, it is difficult to apply an electromagnetic bearing to a rotary pump without disturbing its simplicity, reliability and ability to be implanted. The authors have developed a levitated impeller pump using only permanent magnets. The rotor is supported by permanent radial magnetic forces. The impeller is fixed on one side of the rotor; on the other side the rotor magnets are mounted. Opposite these rotor magents, a driving magnet is fastened to the motor axis. Thereafter, the motor drives the rotor via magnetic coupling. In laboratory tests with saline, where the rotor is still or rotates at under 4,000 rpm, the rotor magnets have one point in contact axially with a spacer between the rotor magnets and the driving magnets. The contacting point is located in the center of the rotor. As the rotating speed increases gradually to more than 4000 rpm, the rotor will disaffiliate from the stator axially, and become fully levitated. Since the axial levitation is produced by hydraulic force and the rotor magnets have a giro-effect, the rotor rotates very stably during levitation. As a left ventricular assist device, the pump works in a rotating speed range of 5,000-8,000 rpm, and the levitation of the impeller is assured by use of the pump. The permanent maglev impeller pump retains the advantages of the rotary pump but overcomes the disadvantages of the leviated pump with electromagnetic-bearing, and has met with most requirements of artificial heart blood pumps, thus promising to have more applications than previously.     

Permanent magnetic-levitation of rotating impeller: a decisive breakthrough in the centrifugal pump

Magnetic bearings have no mechanical contact between the rotor and stator, and a rotary pump with magnetic bearings therefore has no mechanical wear and thrombosis. The magnetic bearings available, however, contain electromagnets, are complicated to control and have high energy consumption. Therefore, it is difficult to apply an electromagnetic bearing to a rotary pump without disturbing its simplicity, reliability and ability to be implanted. The authors have developed a levitated impeller pump using only permanent magnets. The rotor is supported by permanent radial magnetic forces. The impeller is fixed on one side of the rotor; on the other side the rotor magnets are mounted. Opposite these rotor magents, a driving magnet is fastened to the motor axis. Thereafter, the motor drives the rotor via magnetic coupling. In laboratory tests with saline, where the rotor is still or rotates at under 4000 rpm, the rotor magnets have one point in contact axially with a spacer between the rotor magnets and the driving magnets. The contacting point is located in the center of the rotor. As the rotating speed increases gradually to more than 4000 rpm, the rotor will disaffiliate from the stator axially, and become fully levitated. Since the axial levitation is produced by hydraulic force and the rotor magnets have a giro-effect, the rotor rotates very stably during levitation. As a left ventricular assist device, the pump works in a rotating speed range of 5000-8000 rpm, and the levitation of the impeller is assured by use of the pump. The permanent maglev impeller pump retains the advantages of the rotary pump but overcomes the disadvantages of the leviated pump with electromagnetic-bearing, and has met with most requirements of artificial heart blood pumps, thus promising to have more applications than previously.     

无源磁浮人工心脏泵的改进型设计

磁力轴承没有机械接触，机械旋转泵应用磁力轴承后就可以解决机械磨损及轴承处产生血栓的问题，但是，国外使用的磁力轴承均是电磁铁加位置测量及反馈控制，不仅结构复杂，体积大，而且消耗附加电能，整个系统的可靠性也差，作者探索用永久磁铁制作磁力轴承，研制成改进型无源磁浮叶轮泵，泵的转子径向由永磁体磁力支承，转子的一端紧固着叶轮，另一端镶嵌磁钢；与转子磁钢相对，驱动电机线圈产生旋转磁场，驱动转子旋转，在实验室用生理盐水试验，当转子静止或低于4000rpm旋转时，转子磁钢在轴向同位于转子和定子之间的隔板有一点接触，接触点位于转子的轴线上，当转子转速逐渐增加至4000rpm以上，转子在轴向与定子脱离，从而实现完全磁浮，由于转子轴向磁浮由液动力产生，且转子磁钢有陀螺效应，所以转子在浮起的过程中运转非常平稳，当用作左心室辅助装置时，叶轮血泵工作转速范围在5000-8000rpm之间，所以实用时转子完全磁浮是不成问题的，无源磁浮技术是对Earnshaw理论（1842）及Braunbeck推论（1939）的重大补充，将在其它科技领域得到广泛应用。     

An improved design of axially driven permanent maglev centrifugal pump with streamlined impeller

BACKGROUND: In 1839, Earnshaw proved theoretically that it is impossible to achieve a stable equilibrium with a pure permanent maglev. Furthermore, in 1939, Braunbeck deduced that it is only possible to stabilize a super conductive or an electric maglev. In 2000, however, the present authors discovered that stable levitation is achievable by a combination of permanent magnetic and nonmagnetic forces, and its stability can be maintained even with mere passive magnetic forces by use of the gyro-effect. DESIGN CONCEPTS: An improved design of permanent maglev impeller pump has been developed. Passive magnetic (PM) bearings support the rotor radially; on its right side, an impeller is fixed and on its left side a motor magnets-assemble is mounted. Unlike a previous prototype design, in which the rotor magnets were driven by a motor via magnetic coupling, a motor coil is installed opposite to the motor magnets disc, producing a rotating magnetic field. At standstill or if the rotating speed is lower than 4000 rpm, the rotor has one axial point contact with the motor coil. The contact point is located at the centre of the rotor. As the rotating speed increases gradually to higher than 4000 rpm, the rotor will be drawn off from the contact point by the hydrodynamic force of the fluid. Then the rotor becomes fully suspended. KEY POINTS OF STABILIZATION: For radial and peripheral stabilization, a gyro-effect is important, which is realized by designing the motor magnets disc to have large diameter, short length and high rotating speed; for axial stability, an axial rehabilitating force is necessary, which is produced by PM bearings. RESULTS: The rotor demonstrated a full levitation by rotation over 4000 rpm. As a left ventricular assist device, the rotation of the pump has a speed range from 5000 to 8000 rpm. The relation between pressure head and flow rate indicates that there is neither mechanical friction nor hydrodynamic turbulence inside the pump; the former is due to the frictionless maglev and the latter is a result of the streamlined design of the impeller.     

An improved design of axially driven permanent maglev centrifugal pump with streamlined impeller

Background: In 1839, Earnshaw proved theoretically that it is impossible to achieve a stable equilibrium with a pure permanent maglev. Furthermore, in 1939, Braunbeck deduced that it is only possible to stabilize a super conductive or an electric maglev. In 2000, however, the present authors discovered that stable levitation is achievable by a combination of permanent magnetic and nonmagnetic forces, and its stability can be maintained even with mere passive magnetic forces by use of the gyro-effect.

Design concepts: An improved design of permanent maglev impeller pump has been developed. Passive magnetic (PM) bearings support the rotor radially; on its right side, an impeller is fixed and on its left side a motor magnets-assemble is mounted. Unlike a previous prototype design, in which the rotor magnets were driven by a motor via magnetic coupling, a motor coil is installed opposite to the motor magnets disc, producing a rotating magnetic field. At standstill or if the rotating speed is lower than 4000 rpm, the rotor has one axial point contact with the motor coil. The contact point is located at the centre of the rotor. As the rotating speed increases gradually to higher than 4000 rpm, the rotor will be drawn off from the contact point by the hydrodynamic force of the fluid. Then the rotor becomes fully suspended.

Key points of stabilization: For radial and peripheral stabilization, a gyro-effect is important, which is realized by designing the motor magnets disc to have large diameter, short length and high rotating speed; for axial stability, an axial rehabilitating force is necessary, which is produced by PM bearings.

Results: The rotor demonstrated a full levitation by rotation over 4000 rpm. As a left ventricular assist device, the rotation of the pump has a speed range from 5000 to 8000 rpm. The relation between pressure head and flow rate indicates that there is neither mechanical friction nor hydrodynamic turbulence inside the pump; the former is due to the frictionless maglev and the latter is a result of the streamlined design of the impeller.     

A new design for a compact centrifugal blood pump with a magnetically levitated rotor

A compact centrifugal blood pump has been developed using a radial magnetic bearing with a two-degree of freedom active control. The proposed magnetic bearing exhibits high stiffness, even in passively controlled directions, and low power consumption because a permanent magnet, incorporated with the rotor, suspends its weight. The rotor is driven by a Lorentz force type of built-in motor, avoiding mechanical friction and material wear. The built-in motor is designed to generate only rotational torque, without radial and axial attractive forces on the rotor, leading to low power consumption by the magnetic bearing. The fabricated centrifugal pump measured 65 mm in diameter and 45 mm in height and weighed 0.36 kg. In the closed loop circuit filled with water, the pump provided a flow rate of 4.5 L/min at 2,400 rpm against a pressure head of 100 mm Hg. Total power consumption at that point was 18 W, including 2 W required for magnetic levitation, with a total efficiency of 5.7%. The experimental results showed that the design of the compact magnetic bearing was feasible and effective for use in a centrifugal blood pump.     

Magnetically suspended centrifugal blood pump with a self bearing motor

A magnetically suspended centrifugal blood pump with a self bearing motor has been developed for long-term ventricular assistance. A rotor of the self bearing motor is actively suspended and rotated by an electromagnetic field without mechanical bearings. Radial position of the rotor is controlled actively, and axial position of the rotor is passively stable within the thin rotor structure. An open impeller and a semiopened impeller were examined to determine the best impeller structure. The outer diameter and height of the impeller are 63 and 34 mm, respectively. Both the impellers indicated similar pump performance. Single volute and double volute structures were also tested to confirm the performance of the double volute. Power consumption for levitation and radial displacement of the impeller with a rotational speed of 1,500 rpm were 0.7 W and 0.04 mm in the double volute, while those in the single volute were 1.3 W and 0.07 mm, respectively. The stator of the self bearing motor was redesigned to avoid magnetic saturation and improve motor performance. Maximum flow rate and pressure head were 9 L/min and 250 mm Hg, respectively. The developed magnetically suspended centrifugal blood pump is a candidate for an implantable left ventricular assist device.     

体外循环用血泵研究进展

本文在阐述体外循环原理及临床意义的基础上,简单介绍了体外循环用血泵的原理、特点以及关键技术评价指标,重点分析了离心血泵的发展历史,及二代、三代离心血泵磁力驱动的工作原理和特点。第二代血泵采用圆盘形磁力耦合器驱动方式,其永磁体采用组合拉推式结构。第三代血泵是在第二代血泵的基础上增加了磁悬浮系统。最后展望了体外循环用离心血泵的发展趋势。     

Estimation of changes in dynamic hydraulic force in a magnetically suspended centrifugal blood pump with transient computational fluid dynamics analysis

The effect of the hydraulic force on magnetically levitated (maglev) pumps should be studied carefully to improve the suspension performance and the reliability of the pumps. A maglev centrifugal pump, developed at Ibaraki University, was modeled with 926 376 hexahedral elements for computational fluid dynamics (CFD) analyses. The pump has a fully open six-vane impeller with a diameter of 72.5 mm. A self-bearing motor suspends the impeller in the radial direction. The maximum pressure head and flow rate were 250 mmHg and 14 l/min, respectively. First, a steady-state analysis was performed using commercial code STAR-CD to confirm the model’s suitability by comparing the results with the real pump performance. Second, transient analysis was performed to estimate the hydraulic force on the levitated impeller. The impeller was rotated in steps of 1° using a sliding mesh. The force around the impeller was integrated at every step. The transient analysis revealed that the direction of the radial force changed dynamically as the vane’s position changed relative to the outlet port during one circulation, and the magnitude of this force was about 1 N. The current maglev pump has sufficient performance to counteract this hydraulic force. Transient CFD analysis is not only useful for observing dynamic flow conditions in a centrifugal pump but is also effective for obtaining information about the levitation dynamics of a maglev pump.     

The helical flow pump with a hydrodynamic levitation impeller

The helical flow pump (HFP) is a novel rotary blood pump invented for developing a total artificial heart (TAH). The HFP with a hydrodynamic levitation impeller, which consists of a multi-vane impeller involving rotor magnets, stator coils at the core position, and double helical-volute pump housing, was developed. Between the stator and impeller, a hydrodynamic bearing is formed. Since the helical volutes are formed at both sides of the impeller, blood flows with a helical flow pattern inside the pump. The developed HFP showed maximum output of 19?l/min against 100?mmHg of pressure head and 11?% maximum efficiency. The profile of the H?CQ (pressure head vs. flow) curve was similar to that of the undulation pump. Hydrodynamic levitation of the impeller was possible with higher than 1,000?rpm rotation speed. The normalized index of the hemolysis ratio of the HFP to centrifugal pump (BPX-80) was from 2.61 to 8.07 depending on the design of the bearing. The HFP was implanted in two goats with a left ventricular bypass method. After surgery, hemolysis occurred in both goats. The hemolysis ceased on postoperative days?14 and 9, respectively. In the first experiment, no thrombus was found in the pump after 203?days of pumping. In the second experiment, a white thrombus was found in the pump after 23?days of pumping. While further research and development are necessary, we are expecting to develop an excellent TAH with the HFP.     

Recent progress in developing durable and permanent impeller pump

Since 1980s, the author's impeller pump has successively achieved the device implantability, blood compatibility and flow pulsatility. In order to realize a performance durability, the author has concentrated in past years on solving the bearing problems of the impeller pump. Recent progress has been obtained in developing durable and permanent impeller blood pumps. At first, a durable impeller pump with rolling bearing and purge system has been developed, in which the wear-less rollers made of super-high-molecular weight polythene make the pump to work for years without mechanical wear; and the purge system enables the bearing to work in saline and heparin, and no thrombus therefore could be formed. Secondly, a durable centrifugal pump with rolling bearing and axially reciprocating impeller has been developed, the axial reciprocation of rotating impeller makes the fresh blood in and out of the bearing and to wash the rollers once a circle; in such way, no thrombus could be formed and no fluid infusion is necessary, which may bring inconvenience and discomfort to the receptors. Finally, a permanent maglev impeller pump has been developed, its rotor is suspended and floating in the blood under the action of permanent magnetic force and nonmagnetic forces, without need for position measurement and feed-back control. In conclusion, an implantable, pulsatile, and blood compatible impeller pump with durability may have more extensive applications than ever before and could replace the donor heart for transplantation in the future.     

Magnetically suspended centrifugal blood pump with a radial magnetic driver

A new magnetic bearing has been designed to achieve a low electronic power requirement and high stiffness. The magnetic bearing consists of 1) radial passive forces between the permanent magnet ring mounted inside the impeller rotor and the electromagnet core materials in the pump casing and 2) radial active forces generated by the electromagnets using the two gap sensor signals. The magnetic bearing was assembled into a centrifugal rotary blood pump (CRBP) driven with a radial, magnetic coupled driver. The impeller vane shape was designed based upon the computational fluid dynamic simulation. The diameter and height of the CRBP were 75 mm and 50 mm, respectively. The magnetic bearing system required the power of 1.0-1.4 W. The radial impeller movement was controlled to within +/- 10 microm. High stiffness in the noncontrolled axes, Z, phi, and theta, was obtained by the passive magnetic forces. The pump flow of 5 L/min against 100 mm Hg head pressure was obtained at 1,800 rpm with the electrical to hydraulic efficiency being greater than 15%. The Normalized Index of Hemolysis (NIH) of the magnetic bearing CRBP was one fifth of the BioPump BP-80 and one half of the NIKKISO HPM-15 after 4 hours. The newly designed magnetic bearing with two degrees of freedom control in combination with optimized impeller vane was successful in achieving an excellent hemolytic performance in comparison with the clinical centrifugal blood pumps.     

Fault-tolerant strategies for an implantable centrifugal blood pump using a radially controlled magnetic bearing

In our laboratory, an implantable centrifugal blood pump (CBP) with a two degrees-of-freedom radially controlled magnetic bearing (MB) to support the impeller without contact has been developed to assist the pumping function of the weakened heart ventricle. In order to maintain the function of the CBP after damage to the electromagnets (EMs) of the MB, fault-tolerant strategies for the CBP are proposed in this study.Using a redundant MB design, magnetic levitation of the impeller was maintained with damage to up to two out of a total of four EMs of the MB; with damage to three EMs, contact-free support of the impeller was achieved using hydrodynamic and electromagnetic forces; and with damage to all four EMs, the pump operating point, of 5 l/min against 100 mmHg, was achieved using the motor for rotation of the impeller, with contact between the impeller and the stator.     

Design features, developmental status, and experimental results with the Heartmate III centrifugal left ventricular assist system with a magnetically levitated rotor

A long-term left ventricular assist system for permanent use in advanced heart failure is being developed on the basis of a compact centrifugal pump with a magnetically levitated rotor and single-fault-tolerant electronics. Key features include its "bearingless" (magnetic levitation) design, textured surfaces similar to the HeartMate XVE left ventricular assist device (LVAD) to reduce anticoagulation requirements and thromboembolism, a sensorless flow estimator, and an induced pulse mode for achieving an increased level of pulsatility with continuous flow assistance. In vitro design verification testing is underway. Preclinical testing has been performed in calves demonstrating good in vivo performance at an average flow rate of 6 L/min (maximum: >11 L/min) and normal end-organ function and host response. Induced pulse mode demonstrated the ability to produce a physiological pulse pressure in vivo. Thirteen LVADs have achieved between 16 to 40 months of long-term in vitro reliability testing and will be continued until failure. Both percutaneous and fully implanted systems are in development, with a modular connection for upgrading without replacing the LVAD.