We believe the people it affects deserve clear, direct answers. Here are the questions we hear most often about Mi-VAD.
Mi-VAD is an investigational ventricular assist device designed to provide long-term mechanical circulatory support while preserving native cardiac structure and physiology.
Mi-VAD is designed to avoid apical cannulation and ventricular coring by positioning the pump within the natural arterial flow path rather than bypassing the ventricle through a large inflow cannula.
Current durable LVADs save lives but remain associated with bleeding, infection, stroke, driveline complications, and lifestyle limitations. Mi-VAD seeks to reduce these burdens through a different architectural approach.
Mi-VAD is designed as a pulsatile, rhythm-synchronized support system rather than a fixed-speed continuous-flow bypass pump.
The pump is designed to coordinate support with the patient’s native cardiac cycle using ECG gating.
Pulsatile flow more closely resembles natural cardiovascular physiology and may help preserve vascular, valvular, and end-organ function.
Mi-VAD is designed to augment blood flow within the natural circulation pathway without requiring a large inflow cannula inserted deep into the left ventricle.
The platform is specifically designed to avoid apical coring and preserve ventricular structure and integrity.
The system is designed for placement within the ascending aorta for left-sided support and potentially within the pulmonary artery for right-sided support. It can also be placed in the descending aorta for left sided support.
Yes. The architecture is intended to support left-sided, right-sided, or potentially biventricular applications.
The platform is being developed for advanced heart failure and may ultimately have applications in restrictive cardiomyopathy, HFpEF, congenital heart disease, and earlier-stage heart failure.
No. Mi-VAD is an investigational device under development and has not been approved or cleared for commercial use.
Yes. Prototype systems have undergone acute ovine studies demonstrating proof of concept and pulsatile cardiac assist.
Prototype systems have demonstrated pulsatile support up to approximately 10 liters per minute in preclinical studies.
Current development targets include a pump diameter of approximately 18 mm or less.
The pump is expected to weigh approximately 12.7 grams.
Yes. The Mi-VAD pump system is intended to be a fully implantable system utilizing transcutaneous energy transfer to eliminate chronic external power cables.
Percutaneous drivelines remain a major source of infection and quality-of-life burden in current LVAD therapy.
The natural structure and shape of the left ventricle contribute to efficient cardiac mechanics, electrical conduction, and valve function. Mi-VAD is designed to preserve these relationships.
The platform seeks to maintain more physiologic ventricular and valvular interaction than traditional continuous-flow bypass systems.
Mi-VAD is designed around the concept that the native heart rhythm should lead therapy rather than be overridden by a fixed-speed pump.
The platform architecture will incorporate AI-assisted physiologic modeling and adaptive control systems.
Mi-VAD’s design philosophy emphasizes physician-governed, constraint-limited control rather than unrestricted “black box” autonomy.
MPC is an advanced control framework that continuously forecasts physiologic conditions and adjusts pump behavior within predefined safety constraints.
Mi-VAD’s pulsatile, synchronized architecture is structurally compatible with dynamic physiologic control strategies.
The elegance of the Mi-VAD vision that the design supports physiologic adaptation to changing metabolic and circulatory demands.
Potential inputs include ECG, seismocardiography, photoplethysmography, phonocardiography, activity data, and other implantable or wearable-derived signals.
Reducing thrombosis and hemocompatibility complications is a central design objective, although clinical outcomes remain to be established.
The platform seeks to improve physiologic flow characteristics that may ultimately reduce risks associated with current continuous-flow systems.
Elimination of the chronic driveline is intended to eliminate driveline-related infection risk.
Mi-VAD is being developed to support less invasive implantation approaches compared with conventional sternotomy-based LVAD implantation.
The platform is designed to preserve native cardiac structure and potentially support reverse remodeling and recovery-oriented strategies.
The preservation-focused architecture may permit explantability, although this remains investigational.
Unlike conventional LVADs, Mi-VAD is designed to augment native flow rather than fully bypass ventricular function.
Mi-VAD believes that many current LVAD complications are structurally linked to apical cannulation, ventricular coring, continuous flow, and driveline dependency.
Mi-VAD uses the term to describe a new design philosophy emphasizing physiologic integration, adaptive support, and preservation of cardiac structure.
Internal analyses suggest that the clinically eligible advanced heart failure population is substantially larger than the currently treated LVAD population.
Many patients and physicians remain hesitant due to surgical invasiveness, complication rates, lifestyle burden, and recurrent hospitalizations.
That is one of the long-term strategic goals of the platform.
No. The platform is being designed for bridge-to-transplant, destination therapy, and potentially earlier-stage intervention.
The platform architecture may offer future applications in certain congenital and Fontan-related circulatory conditions.
Mi-VAD’s non-cannular architecture may ultimately allow applications not well suited to current LVAD therapy, including selected HFpEF populations.
Most competing durable LVADs continue to follow the same apical cannulation paradigm established by earlier generations of devices.
Mi-VAD holds a substantial patent portfolio covering architectural, location, mechanical, and control-system concepts relating to the platform.
Mi-VAD believes the key differentiation lies not in a single component, but in the overall integration of pump placement, pulsatility, sensing, and adaptive control.
Yes. The broader platform vision includes remote patient and device monitoring capabilities.
Development collaborations and advisors include engineering, manufacturing, and clinical participants with experience in advanced heart failure and mechanical circulatory support.
Mi-VAD has completed proof-of-concept work and is pursuing optimization, bench testing, and both acute and chronic longer-duration preclinical validation studies in animals prior to investigational first-in-man studies.
A central objective of the platform is to reduce lifestyle burden by minimizing invasiveness, eliminating the driveline, and enabling more physiologic support.
Yes. The long-term vision of the platform is durable ambulatory support with fewer restrictions on daily activity and mobility.
Lower power requirements improve the feasibility of fully implantable systems and wireless energy transfer technologies.
Reducing complications such as infection, bleeding, thrombosis, and right-heart dysfunction is intended to decrease recurrent hospitalizations and long-term system costs.
No. Mi-VAD’s long-term philosophy is that future circulatory support systems should function as integrated physiologic therapy platforms rather than static mechanical bypass pumps.
The architecture is intended to support individualized control strategies based on patient-specific physiologic data and adaptive modeling.
Mi-VAD believes the future of durable support lies in smaller, smarter, less invasive, fully implantable systems that work with the native heart rather than mechanically overriding it.