PULVAD is implanted intrathoracicly and consists of:

a) a rigid spheroidal body made of polyurethane
b) a flexible membrane made of polyurethane and silicone;
d) a vascular graft (Dacron);
e) an air tube
f) 5 ECG leads.

Characteristics

• Small total volume (20 cc)
• Is implanted with 5 ECG leads

PULVAD’s safe manufacture is based on the biocompatible and medical materials used in its production. Moreover, it is ensured by the fact that its design does not allow air embolism in case of membrane rupture.

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

• Impressive pressure unloading leading to the effective support of the left ventricle and the 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).
• Relatively simple implantation and explantation surgery or deactivation (without explantation).
• The surgical implantation/explantation of PULVAD is performed via partial clamping of the ascending aorta to block the blood circulation unlike other similar LVADs which require extracorporeal circulation.
• The surgical implantation, explantation or deactivation of PULVAD leaves the heart intact.
• The surgical implantation, explantation or deactivation of PULVAD does not involve destruction or removal of part of the myocardium since the device is implanted in the ascending aorta.
• Pulsative flow which has been associated with higher rates of myocardial recovery.
• Low cost, wide availability and easy operation of the Arrow AutoCAT 2 console system (PULVAD’s external power unit). PULVAD has a relatively simple design (no complex electromecanical parts), low production and marketing cost. It is estimated that PULVAD’s cost would be higher than the cost of the IABP (~1.500€) and much lower in comparison of the currently available devices of short-term support of the circulation whose cost is between 5.000-10.000€ per unit. It must also be taken into consideration that the cost of devices used for long-term support of the circulation, exceeds the amount of 200.000€ (Τhoratec Corp). The wide availability of the Arrow AutoCAT 2 console PULVAD’s external power unit, makes it a cost-effective therapeutic solution that could be used immediately in all hospitals around the world that have organized cardiology and cardiac surgery units. PULVAD’s operation does not required specialized technical personnel. Any ΙΑΒP console savvy (even the patient after proper training) could handle it.
• Low rate of complications associated with its use. PULVAD operates in synchronization with the innate cardiac circle. Unlike the currently used devices which induce unloading, 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 cardiac circles. The absence of valves and complex electromechanical components significantly reduces the risk of hemolysis, thrombus formation and thromboembolic events.

Benefits: The PULVAD solution creates positive externalities for both patients, their quality of life and their families, as well as for the health system and medical staff.

Pulvad Prototype Device

“Odysseus” clinical trial

Clinical Trial “Admetus”

Entry criteria

1. Men and women ≥18 years old.
2. Patients in end-stage heart failure due to idiopathic dilated cardiomyopathy and Left Ventricular Efection Fraction (EF) ≤ 35% during the last 6 months from the screening visit evaluated by heart ultrasound, MRI or cardiac ventriculography.
3. Patients must be in either INTERMACS 2 or 3 profiles. Patients in INTERMACS 1 are also candidates provided that they are not stabilized with the support of the Intraortic Balloon Pump (IABP).
   As stabilization under the mechanical assistance with the IABP, we mean: the no further intravenous administration of inotropes/diuretics, the absence of malfunction indications of the peripheral organs, the patient’s tolerance of the medical treatment of heart failure in therapeutic doses (betablockers, ACE inhibitor), central venous pressure ≤ 10cmH2O, Heart Rate ≤ 85 beats, Mean Blood Pressure ≥ 70mmHg).
4. Signing an informed consent form for the patient’s participation in the study and being able to comply with its requirements

Contact Info
Evaggelismos General Hospital
Department of cardiac-thoracic-vascular surgery
Coordinator Director: Christos Charitos Cardiothoracic surgeon
Tel. 2132041593