Greek Innovation – PUVLAD

The PULVAD is a unique Pressure Unloading Left Ventricular Assist Device that reduces the heart’s workload and allows it to recover normal function over an implant period of up to 6-9 months. This curative therapy is elegantly simple: the PULVAD reduces the pressure that the heart pumps against. Unlike Left Ventricular Assist Devices (LVADs) in current use, the PULVAD does not completely usurp the heart’s pumping function, causing it to atrophy and eliminating all potential for recovery. Existing LVADs save lives, but to do so they must literally sacrifice the patient’s heart.     

Like existing devices, the PULVAD can also be used as a bridge to other treatments, such as cardiac transplantation or permanent LVAD implantation. Unlike existing LVADs, our device is inexpensive to manufacture (about 5% of the cost of manufacturing the HeartMate 3, the most frequently implanted LVAD) and its simple implant procedure does not require a cardiothoracic surgeon or a hospital with sophisticated cardiac surgery capabilities. Thus, it will greatly widen the market for mechanical cardiac support to patients in developing and developed countries without sufficient affluence or access to heart surgery hospitals.

PULVAD operates on the basis of the counterpulsation technique and is capable of achieving a great reduction of the workload of the heart (~ 50%), enabling it to achieve recovery within 6-9 months (anatomical and functional reconstruction of the heart). The patient, after the termination of PULVAD’s operation, will have little or no symptoms of heart failure. Otherwise, a heart transplant or LVAD may be needed as a permanent treatment for heart failure.

The PULVAD, as a device aiming at myocardial recovery, presents significant advantages over the other currently available LVADs

1. Impressive pressure unloading leading to effective support of the left ventricle and intrinsic cardiac muscle function by increasing its pulse volume (other currently used LVADs suppress the functionality of the left ventricle by reducing its pulse volume).
2. Relatively simple implantation and explantation surgery or deactivation (without explantation). The surgical implantation/explantation of the PULVAD is performed via partial clamping of the ascending aorta, unlike other similar LVADs which require cardiopulmonary bypass.
3. The surgical implantation, explantation or deactivation of the PULVAD leaves the heart intact  since it is implanted on the ascending aorta and does not involve destruction or removal of part of  the myocardium, which is required for insertion of other LVADs
4. Pulsatile flow which is associated with higher rates of myocardial recovery.
5. Low cost, wide availability and easy operation. The PULVAD has a relatively simple design (no  complex electromechanical parts) and low production cost ($1,7K), much lower in comparison of the  currently available devices (short-term support devices $10K-25K, long-term support devices > $200K).  The PULVAD’s operation does not required specialized technical personnel. Anyone with ΙΑΒP console  training (even the patient) could handle it.

Low rate of complications associated with its use. The PULVAD operates in synchronization with  the innate cardiac circle. Unlike the current used devices which induce unloading, the PULVAD does  not cause right heart failure or dysfunction of the right ventricle. To the contrary, it contributes to the unloading and recovery of the right ventricle because it does not interfere with the interaction of the  two ventricles. The absence of valves and complex electromechanical components significantly  reduces the risk of hemolysis, thrombus formation and thromboembolic events.