FDA Approved in 2014 - CardioCel® : tissue regeneration of heart valves

[NewbieSlo]

I stumbled upon this news:

"February 09, 2014 09:05 PM Eastern Standard Time BRISBANE, Australia--(BUSINESS WIRE)--Admedus (ASX:AHZ) today announced it has received FDA clearance to market CardioCel[SUP]®[/SUP] in the US. CardioCel[SUP]®[/SUP] is the group’s lead regenerative tissue product to repair and treat a range of cardiovascular and vascular defects. The Company will now look to complement its existing product launch in Europe with preparation for initial sales in the US.

The intended use of CardioCel[SUP]®[/SUP] in the US is in pericardial closure and for the repair of cardiac and vascular defects in both adults and paediatrics.

“This is a significant milestone for the Company as we expand into global markets and further develop our range of regenerative tissue products for commercialisation and sale.” said Mr. Lee Rodne, CEO of Admedus Ltd.

“CardioCel[SUP]®[/SUP] is an important addition to the surgeon’s armoury in the treatment of congenital heart disease, as well as for the repair of heart valves and other cardiac defects” he said. "

For more info, please visit: http://www.businesswire.com/news/ho...Admeduss-CardioCel®-Cleared-Sale#.U-EYyXS2hMs

And also: http://www.biomelbourne.org/news_items/view/503

This sounds really exciting!

 

[pellicle]

it does! Curious date from your posted news item too.

 

[river-wear]

That sounds similar to: http://www.cormatrix.com/PatientInformation-26

I talked to a couple of surgeons about it - it looks like cool stuff. However, it isn't sturdy enough for leaflet repair - too much blood flow (movement) and pressure.

 

[Rebecca]

Last fall I visited CorMatrix lab in Roswell, GA. Their lab was awesome. At the time they had two infants in Europe with their heart valves. http://www.cormatrix.com/Newsroom-13
My husband is in this study. http://www.dicardiology.com/article...t-absorb-trials-united-states-japan-and-china

 

[NewbieSlo]

Hi Rebecca, river-wear,

thanks for posting additonal info. I was aware of the studies with bioresorbable vascular scaffold, but this (CardioCel) is the first time I read and article that speak directly about regeneration of heart valves and not vessels.

I know that it can not be a miracle solution to solve all valve related problem, but to me it does sound like a breakthrough: for some people it might change their life completely but it might serve also as a starting point for further developments/innovations.

 

[NewbieSlo]

Ohhh, Rebecca I only now saw the news on the link you posted, that CorMatrix also received patents for Heart valves. It is great to see, that things are developing and that perhaps we will not need to wait 10 or 20 years for some major breakthrough.

 

[NewbieSlo]

A went to re-read artcles about CardioCel. And yes, while it got FDA approval, it is to my understanding not (yet) for valve repair, since it is written only: The intended use of CardioCel[SUP]®[/SUP] in the US is in pericardial closure and for the repair of cardiac and vascular defects in both adults and paediatrics.


Regarding valve reapir I believe tat this could prove useful as well, but more studies will be needed before getting approval. It is written:

"About Allied Healthcare Group’s Heart Valve Reconstruction Study

The study, in a heart disease animal model, was designed to demonstrate the potential of the ADAPT® treated CardioCel® patch, versus the standard of care control, to surgically repair damaged or congenitally deformed heart valves. The model is recognised as being highly representative of the human condition associated with valvular abnormalities.

The CardioCel® patch was used during open heart surgery, as surgeons performed double valve leaflet reconstruction procedures. The CardioCel® patch material was successfully used to reconstruct the posterior leaflet of the mitral valve as well as one of the valve leaflets of the pulmonary valve. Treated autologous pericardium (native tissue) was used as the control for reconstruction of the mitral and pulmonary valves.

Eight months post-surgery, echocardiography was used to determine valve function and to detect the presence of valve calcification. Valves were retrieved and assessed for immune responses (cytotoxicity), remodeling and structural degeneration by means of microscopic evaluation of antibody markers, histological stains and molecular quantification of calcification levels.

The result highlights are:

• Endothelialisation (initial formation of an endothelial layer) of both valve surfaces, the developmental prerequisite for a normal physiological heart valve-blood interface.

• The generation of new valvular collagen on both sides of the valve reconstructions, which resembles typical native valve tissue and indicates progression to a repaired heart tissue.

• The transdifferentiation of some of the valvular interstitial cells into functional phenotypes such as new smooth muscle cells.

• Molecular examination of the extractable calcium showed 40% less in CardioCel® compared to the autologous control tissue.

• No echocardiographic evidence of calcification in the CardioCel® treatment arm

http://www.biomelbourne.org/news_items/view/503

So since this were pre-clinical studies on animals, they need to be followed by clinical. Perhaps they are already on-going, since this post above is from end 2012.

 

[NewbieSlo]

I did some further research on CardioCel and yes, things are moving forward. I found this information from July 2013:

CardioCel is a cardiovascular tissue product used to repair heart deformities including repairing and reconstructing heart valves, and Brisbane-based pediatric and adult heart surgeon, Dr Homayoun Jalali, has been granted approval to use it.

Dr Jalali is the sixth surgeon to obtain access to use CardioCel under early access schemes which allows Australian surgeons to apply to use the product prior to full marketing approval."This is a key step for Allied as it represents the first adult surgeon to gain access to use CardioCel under the Authorised Prescriber Scheme.
Ten years of preclinical and clinical studies have shown CardioCel patches have no evidence of cytotoxicity or calcification at the site of repair for four years post-surgery. CardioCel has also shown superior cell survival and regenerative properties when compared with existing gold standard patches implanted with stem cells.

See more at: http://www.biospectrumasia.com/bios...s-cardiocel-surgeons-nod#sthash.X4lQi0bW.dpuf


And than in October of 2013, this additional news:

There are now 14 surgeons in Australia that are authorized to use CardioCel for the repair of heart defects with over 60 patients having successfully received the tissue implant since the initial procedure was performed.

See more at: http://www.biospectrumasia.com/bios...s-surgeons-nod-australia#sthash.3pYoDgUR.dpuf


I'm still not usre though, if they use it for recounstruction of heart valves. Hmmmm.... I'll keep on surching I guess, if I come up with poszive information on that, I'll let you know

 

[NewbieSlo]

In Europe, CardioCel received CE mark approval, which allows for: for the repair and reconstruction of heart defects including treating congenital heart disease and repairing heart valves in both children and adults.

http://www.proactiveinvestors.com.a...diocel-regenerative-tissue-product-47148.html

Ok, that is enough from me on this topic (for today at least

 

[Rebecca]

I do think that this will be the future of valve replacement. CorMatrix has learned to turn off the cells in our bodies that cause scaring. I saw pictures of a hand with 3[SUP]rd[/SUP] degree burns and with CorMatrix product it healed quickly and had no scaring. Amazingly the hand again had finger prints.

http://www.mch.com/press/EN/389/TEC...HEART-DEFECTS---Miami-Childrens-Hospital.aspx

http://www.businesswire.com/news/ho...cular-Receives-U.S.-Patents-Biomaterial-Heart

 

[NewbieSlo]

It does seem indeed, that CorMatrix and CardioCel work similarly. I found one additional report on CorMatrix usage in mitral valve repair:


http://www.ncbi.nlm.nih.gov/pubmed/24332188

 

[NewbieSlo]

And another usage of CorMatrix in tricuspid valve repair: http://www.sciencedaily.com/releases/2014/01/140127093150.htm


And again on mitral valve repair with CorMatrix:

The first mitral valve reconstruction using CorMatrix occurred at St Francis Heart Center as well, in October of 2008. Large defects had been created in a patient’s valve by infection. The valve was restored to normal function using CorMatrix patches, avoiding a valve replacement.

“We have been able to make similar repairs for other patients since,” added Gerdisch.

http://cardiactissuerepair.net/DesktopDefault.aspx?tabid=123


I also like the idea of repair more than replace, hope it will become more widely practiced soon

 

[river-wear]

Did you see any references to aortic valve testing? That has the highest pressure, so maybe they're trying those less likely to fail first. Another cool option would be if they can use the material to create a scaffold for growing a replacement cell from native tissue (stem cells).

 

[NewbieSlo]

I did find this article on aortic valve repairs:

1.)

Between August 2009 and April 2011, 26 patients (mean age 6.4 years, range 8 days–32 years) underwent congenital heart disease repair using an ECM patch, the CorMatrix ECM (CorMatrix Cardiovascular, Atlanta, GA, USA), for cardiac tissue repair and pericardial closure. In 27 circumstances, the ECM patch was used for cardiac tissue repair: in 10 for pulmonary artery patch arterioplasty, in nine for valve leaflet extension, in four for ascending aortic patch aortoplasty, in three for aortic arch reconstruction (one in hypoplastic left heart syndrome) and in one for right ventricular outflow tract reconstruction. In four patients, the patch was also used for pericardial reconstruction.

Results: Among patients treated for aortic valve disease, none had residual aortic regurgitation >1+, and in the subgroup with aortic valve stenosis (four patients) a peak residual gradient of 23±8 mmHg was observed.

http://icvts.oxfordjournals.org/content/13/6/569.full


2.) In this one: http://www.sciencedirect.com/science...2252231400525X

If I understand correct, they are not convinced in long term results: Conclusions

The present study has shown that postrepair left ventricular work did not increase despite a decrease in geometric orifice areas in the Hemashield and CorMatrix groups. The autologous porcine pericardium and St Jude Medical pericardial patch had the closest profile to normal AVs; therefore, either biomaterial might be best suited. Finally, the increased stresses found in the bovine pericardial patch, Hemashield, and CorMatrix groups might, after prolonged tensile exposure, be associated with late repair failure.


3.) Then there is another thing: if I do understand correct, CardioCel is saying, that their technology is likely to improve considerably the durability of tissue valves (so here we are not speaking of repair anaymore, but improving durability of replacement tissue valves is nother important step, since not all the valves can be repaired - at least not at this point in time). But they have not come yet to the market with their tissue valves, it is planned for 2016/2017:

What they claim is: Celxcel’s heart valve replacement tissue, CardioCel[SUP]®[/SUP],has the potential to greatly increase the lifespan of implanted bio-prosthetic tissue, either as part of a valvular reconstruction or ultimately to replace the faulty valve itself.
http://3dfieldinmotion.blogspot.com/...-analysis.html


I do think that in 10, 15 years time there will be important changes in the way they approach valve repair and replacement (not just in a couple of big center in the world, but in general approacj towards valve disease), the only problem is, that majorit yof us in this site would need that to hapen much sooner.

 

[NewbieSlo]

It's time to upadte this thread on uses of CardioCel in aortic valve repair:



Admedus Limited (ASX:AHZ) has started a clinical study into aortic tri-leaflet heart valve reconstructions using its cardiovascular bio-scaffold CardioCel following a successful pre-clinical study.

The study will address aortic stenosis, or narrowing, which is the most common valvular heart disease in developed countries.

It gives surgeons access to a bio-prosthetic tissue that can withstand this high pressured area within the heart, not calcify and facilitate host tissue regeneration.

The pre-clinical study was undertaken in conjunction with KU Leuven University in Belgium.

The study, which will further support the use of CardioCel in heart valve repair and reconstructions, will be undertaken in four leading heart centres in Europe and the U.S.

A total of 80 adult patients will be recruited with initial cases already enrolled.

The primary safety endpoint for the clinical study is to ensure same rates of in-hospital survival, while also looking for superior long-term benefits for patients, better haemodynamic outcomes, cell infiltration, regrowth of native tissue and long-term durability without calcification.

Admedus has already been very successful in its initial launch strategy of introducing CardioCel to leading congenital centres in the U.S. and Europe with over 95 centres now using it to treat congenital heart defects.

Lee Rodne, chief executive officer, commented:

“Off the back of a very successful pre-clinical study, we have now commenced a clinical study to provide further data to use CardioCel for complete aortic valve reconstructions.

“This is an important study in aortic valve reconstruction, which has never been done before with a bio-prosthetic tissue like CardioCel.

“We believe the results will highlight the patient benefits of completely reconstructing the aortic valve with CardioCel compared to the current industry need of replacing it multiple times throughout a patient’s life.”

http://www.proactiveinvestors.com.a...-starts-heart-valve-clinical-study-64695.html

 

[Nocturne]

My AS is "very mild" at this time -- JUST under the official threshold. I wonder if this could pan out in time for me. Sure would be nice to keep my original parts.

 

[ATHENS1964]

https://www.proactiveinvestors.com....ent-following-clinical-savr-trial-916643.html

 

[ATHENS1964]

https://admedus.com/about