Aortic valve disease is the most common cardiac anomaly and is often associated with leaflet defects. Traditionally, aortic valves have been replaced with a bio-prosthetic or mechanical heart valve, even though these replacement methods were associated with suboptimal outcomes such as calcification resulting in re-operation.
While far from the optimal choice, the need to use bio-prosthetic valves rather than simply reconstructing the valve area, was due to the fact that tissues available until this point had failed, suffered rejection, calcified and were not able withstand such a maintained high pressured area within the heart. This has changed with the arrival of CardioCel®, Admedus’ lead bio-scaffold product.
CardioCel has been proven to have the high tensile strength to work in a pressured environment like the aortic valve, as well as having the added benefit of not calcifying or experiencing post-implantation rejection like other tissues and instead actively facilitates host tissue regeneration. This is a huge advantage for patients, as it means that if their valve is reconstructed using CardioCel, they can avoid the need to have repeat surgeries later in life.
While CardioCel was already approved for valve reconstruction in the US, we recently announced a label expansion in Europe, meaning CardioCel is now approved in that market for the repair of intracardiac defects including septal defects, and valve and annulus repair. You can read the full announcement from Admedus here. CardioCel is available for valve repairs in all countries it is sold in, for both adults and children, providing patients with access to a next generation tissue.
To date, we have collated extremely positive clinical and pre-clinical study results, as well as real patient evidence to give us confidence to say that reconstructing aortic valves with CardioCel offers superior outcomes when compared to replacing the valve with a bio-prosthetic.
Dr Domenico Mazzitelli and colleagues from the Berlin Heart Institute published their clinical results using CardioCel in complete aortic valve cusp replacement in three cases of severe pediatric aortic valve defects. You can read the full manuscript here. All patients achieved excellent early results and are being followed without complications (no mortality, no reoperations after 12 months). These procedures illustrate the application of CardioCel in heart valves, as well as highlighting its previously demonstrated utility in cardiovascular repairs and reconstructions. In addition to the manuscript, you can watch Dr Mazzitelli discuss his experience with CardioCel here.
Admedus has also recently completed further studies in aortic valve reconstruction in a sheep model, with successful outcomes. The results showed that CardioCel can offer improved haemodynamics, there were no signs of calcification and over time post-implant remodelling, establishing a native functioning heart valve. Please find the full announcement and results on our website here.
Please click on the infographic below to enlarge it.
Post-market approval study in aortic valve reconstruction
Following successful clinical cases, as well the recent completion of a pre-clinical study, Admedus is undertaking a post-market approval clinical study with leading heart centres to further bolster the clinical data available for CardioCel, to demonstrate the benefits to patients in whole valve reconstructions over bio-prosthetic valve replacement. The study will address aortic stenosis, or narrowing, which is the most common valvular heart disease in developed countries.
We are actively recruiting for our clinical study, with the aim of recruiting 80 patients across leading heart centres in Europe and the US. You can read our full release on the study here.
Challenging the TAVR market and approaches to heart valve repairs
We believe by enabling surgeons to intervene at an earlier stage of cardiovascular disease and reconstructing the aortic valve using CardioCel, we may be able to offer a true alternative to using a Transcatheter Aortic Valve Replacement (TAVR) later in life.
The TAVR procedure is currently undertaken in people who have been diagnosed with severe aortic stenosis and are considered either high-risk or too sick for open heart surgery and instead have the device delivered through an artery. Admedus is working with surgeons to use CardioCel as an earlier treatment for patients, so they are less likely to progress to the point where TAVR is necessary. In effect, reconstructing the heart valve when the patient is younger and providing that patient with a long term solution, rather than waiting for their condition to deteriorate further before treatment.
While a TAVR addresses the immediate issue of blood backflow in the heart, it doesn’t result in a natural function within the valve. CardioCel, on the other hand, is sewn in to reconstruct the leaflets and is eventually populated with cells to become part of the heart, enabling full movement of the valve. In addition to aortic valves, CardioCel has been shown to be useful in other valves such as mitral valve repairs. You can read more on this here.
We hope to see further support for the reconstruction of valves, compared to the current reliance on prosthetic alternatives and interventional cardiology management programs.
Dr Julian Chick
Chief Operating Officer