Clinical Need
450,000 patients are diagnosed each year with congestive heart failure in
the USA alone. Treatment options for this group include transplantation of
a donor heart or the implantation of a mechanical ventricular assist device
(VAD) which directly pumps the patient’s blood and supplements the output
of the diseased heart. Both these invasive procedures are costly, have associated
complications and are only suitable for patients under the age of 60. RANIER
has facilitated a consortium of clinicians, technologists, academics and medical
device developers that has prototyped a new concept in cardiac support designed
for:
independent ambulatory support to the diseased heart
implantation using minimally invasive techniques
non blood contact
significantly lower cost than alternative procedures
use earlier in the disease process
use in patients older than 65 who are denied current therapies
the basis for Combination Therapy, leading to reversal of the disease process
By supplementing the work to be done by the heart it is proposed that cardiac assist devices can support ailing hearts during drug therapy leading to a potential recovery of full heart function.
Current Development Status
The consortium has submitted the relevant patent applications and has developed
the device to prototype stage. The prototype has successfully demonstrated
proof of principle in-vitro. RANIER has assembled a complex benchtop aortic
model with variable flow, pressure and compliance characteristics that can
simulate the performance of the human circulatory system. By using the model
the effect of the Cardiac Assist Device and Intra Aortic Balloon (IAB) on
blood flows and pressures can be assessed and quantified. In vitro
and in vivo data has
indicated that the new Cardiac Assist Device has the potential to outperform
the IAB, providing superior assistance to the heart with a significantly lower
inflation volume.
Intellectual Property
A PCT Application (international application no. PCT/GB01/04250) was filed
in 2001.
Commercialisation
The
market size for the Cardiac Assist Device is prudently estimated at over £2bn
for the US and European markets.
