The company MicroMed Cardiovascular Inc. has been developing the HeartAssist 5® for some time, an LVAD that combines the technology of the HeartMate II® from Thoratec and that of the HVAD from the company HeartWare in a new generation LVAD.
The US FDA has authorized MicroMed to conduct research into the effectiveness of the HeartAssist 5® compared to Thoratec's Heartmate II®. Such permission is not easily granted, it requires years of intensive research and the provision of convincing evidence that this pump is good enough to be tested on humans.
On June 14, 2012, MicroMed issued a press release announcing the exciting news that the FDA has issued an “Investigational Device Exemption (IDE)” for the HeartAssist 5® . An IDE is the official permission to conduct research in this case into the effectiveness of the HeartAssist 5® compared to the Heartware II®.
Read the Dutch translation of this press release here.
What's so special about this LVAD?
MicroMed has tried as much as possible to trace the disadvantages and side effects of the LVADs used so far and to find solutions for them.
The HeartAssist 5® is for the time being with its 92 grams and 71 x 38 mm. the smallest LVAD and virtually silent. The pump can pump 2 to 10 liters of blood per minute, so it is strong enough for very large adults, but can also be used with children from 18 kg!
MicroMed has permission in both America and Europe to implant the HeartAssist 5® in children and to investigate whether the LVAD is also suitable for this group. Due to its size and capacity, the HeartAssist 5® could already be used on children from 4 to 6 years old.
Because the HeartAssist 5® is so small, it can be placed above the diaphragm in the pericardium. The big advantage of this is that the operation itself is less large, after all, it only takes place in and around the heart and does not need to be extended to the abdominal cavity, which is still the case with the Heartmate II®. In addition, with a pump placed in the abdominal cavity, openings are made in the diaphragm, which is therefore not necessary with this implant.
dr. Michael Debakey, in collaboration with NASA, has developed a strong motor that can pump the blood around in such a way that as little damage as possible is administered to the platelets.
In the development of this pump, tests were carried out with a swimming pool full of balloons filled with water that were pumped around without the balloons breaking!
The HeartAssist 5® has a special function in which the check on the functioning of the pump and the amount of blood that is pumped is much more accurate than was the case until now. Thanks to a measuring device that is inserted into the tube that goes to the aorta, the 'Direct Measurement Flow Probe', the exact amount of blood passing through it is measured. With current LVADs, this measurement is estimated by calculation and is not nearly as accurate.
This information is useful if the patient is stable, but can be decisive when complications arise.
Thanks to a monitoring system, the patient connects the HeartAssist 5® controller to the HeartAttendant at night, which then sends all the data of that day about the blood flow and any other data to the hospital. In the event of (starting) calamities, action can be taken at short notice. On the other hand, this can also save unnecessary trips to the hospital.
MicroMed also has a brochure published where this monitoring can be read in detail.
For more information, please visit the website of MicroMed.
