ValveXchange: Lifetime Tissue Valve Platform

[Jennie]

Very interesting future technology!

http://phx.corporate-ir.net/phoenix.zhtml?c=80253&p=RssLanding&cat=news&id=1582987

Quote:
Steven G. Anderson, Chairman, President and Chief Executive Officer of CryoLife, said, "We believe that the ValveXchange technology is an extremely compelling next generation heart valve approach. Its unique replaceable bioprosthetic leaflet design has the potential to eliminate repeat open heart surgeries from the long-term wear complications associated with current biological valves. We believe that the system may resolve the long standing compromises between conventional mechanical and biological heart valves, potentially making this platform applicable to patients of all ages...."

 

[ElectLive]

Very interesting indeed, thanks for posting. Nice disclaimer paragraph, but that goes with the territory. Maybe none of us will ever see it, but the same was said in the past about some of the commonly used valve technology of today. So, the long, long, long wait begins...

 

[ottagal]

Thanks for sharing this very interesting article!

 

[luvsgod]

Broken Sternal Wires

Broken Sternal Wires

Jennie,
I am curious - why did you have sternal wire removed 4/24/03? I have had xrays, etc. that show I have broken sternal wires but no doctor seems concerned so I guess it's in the norm. Thanks!

 

[neil]

interesting stuff

 

[normofthenorth]

Fascinating! In hindsight, the idea of an intentionally "serviceable" bioprosthetic heart valve makes total sense -- as in, "It's so obvious, why didn't we all think of it?"

 

[Jennie]

Hi luvsgod (I like the name!!),

I had gone back to Mayo Clinic for my one-year follow-up exam with my surgeon. I was planning to ask him about my wires, as I knew some people had had them removed. I could feel one of them through my skin, as it was bumped out a bit, and I could actually move it back and forth a bit. It would knock against my guitar when I played. But before I could ask the surgeon, he took one look and asked ME if they bothered me, that he could take them out. Since my insurance would cover it, I went ahead with it. It was supposed to be an outpatient surgery, but they took me up to the floor afterwards, and refused to let me go until the surgeon came in and gave them approval, after he finished all his surgeries that day. So while I was sitting around, I learned from the nurses that most "sternal wire removal" patients were NOT outpatients, and that they are usually in seriously bad shape when they come in. Apparently, for reasons that I don't know, the wires/sternum can get infected, and they have to remove the sternum, and you can imagine what that would do to a person's structure. So while I had been a bit unsure went I went in for the surgery (was this really necessary??), these nurses assured me that I had done the right thing.

Anyway, I hope this helps. I don't know what the implications are when sternal wires are broken. I would at least think it is something to keep an eye one?

 

[ElectLive]

Fascinating! In hindsight, the idea of an intentionally "serviceable" bioprosthetic heart valve makes total sense -- as in, "It's so obvious, why didn't we all think of it?"

Agreed. Of course, from a patient perspective, why didn't they think of it sooner!

 

[ElectLive]

I meant to post an update to this thread a few weeks ago:

http://www.valvexchange.com/news/documents/ValveXchange_First_In_Man_Press_Release_10-5-11.pdf

"DENVER (October 5, 2011) – ValveXchange, Inc. has performed successful First In Man (FIM) surgeries demonstrating the practicality and advantages of its novel Vitality™ two-part heart valve system.

The surgeries were performed by two highly renowned US cardiac surgeons, Lars Svensson, MD, PhD of The Cleveland Clinic and W. Randolph Chitwood, MD of The East Carolina Heart Institute, working with Adrian Ebner, MD at his facilities in Asuncion, Paraguay. The surgeries took place Sept. 26 and 27, 2011. Three men aged 49, 62 and 72 received the Vitality™ heart valves. All have been discharged and are recovering normally.

The ValveXchange® concept is a two-part valve with a permanently implanted base and an easily replaceable leaflet set. The leaflet set is designed to be replaced transapically (through the apex of the heart), accessed by a small incision between the ribs and not requiring any future open-heart surgeries. ValveXchange® is currently developing the tool set for the transapical leaflet replacement procedure. Leaflets can also be replaced using standard and minimally invasive surgical techniques that are faster and simpler than traditional valve replacement surgeries.

Of the FIM surgeries Dr. Chitwood said, “These cases went extremely well. We think we’ve got an excellent valve concept. You can look below the valve before you put the leaflet set in and see exactly how the valve is seated. The patients have come off bypass without any difficulty, excellent gradients, good cardiac outputs and good ventricular function.” Dr. Svensson added, “With other valves if you break a suture you’re basically committed to taking the valve off and out. Here there are no leaflets, so it’s very easy to see and put in extra sutures.”

ValveXchange® will now be pursuing clinical trials in Europe, which allows the most straightforward and predictable regulatory approval pathway. Clinical trials are expected to begin in early 2012 with European regulatory approval expected in late 2012 or 2013.

All ValveXchange® heart valves are designed for long durability and leaflet exchangeability. The Vitality™ model, which has just been implanted in the FIM studies, is intended for the broad adult aortic valve marketplace. ValveXchange® also is developing the Vanguard™ series of transcatheter valves (for transapical and transfemoral implant) that are being designed to incorporate the same durability as surgical valves and the same leaflet replacement feature as the Vitality™, but for the aged, non-surgical patient population."


I found it interesting to learn that there are plans to merge with the transcatheter approach. Oh, and by the way, if you follow the full link, bear in mind that it is a marketing material. I can imagine many of our mechanical valve folks will be more than a little offended by the "sedentary lifestyle" comment...

 

[camgough]

Very interesting stuff!

 

[JLant]

I believe this is a technological break-through and it has a potential to change the competition in the heart valve industry. I've been following this company for a while. Their website is http://www.valvexchange.com.

From Dr. Ivan Vesely, the founder's March 2012 e-newsletter,

--------

Dear Colleague,

The year 2012 is when we perform full scale clinical testing of our products in the EU. The year 2013 is when we plan to start selling the Vitality™.

A lot of things have to come together to make this happen. Resources in terms of manpower, funding and facilities on the ValveXchange side, and partnerships in terms of Clinical Sites and Clinical Trials management in Europe. Many of these things involve new people who have joined the company. Getting to First-in-Man was a huge milestone for us, but following that single site episode with 8 potential Clinical Sites in 4 countries, and developing three additional valve sizes, is something far more grand.

As a company, we are now fully vertically integrated with a certified Class 10,000 Clean Room with a capacity to produce 2,000 valves per year, per each 8 hour shift. We are thus ready and able to support a market launch immediately after CE Mark is awarded, hopefully early in 2013.

It is a lot of work, and we won't get to as many trade shows this year as we have in the past. But I still hope to see many of you at this year's key clinical conferences.

-----------

So, it looks like the future is near.

 

[ElectLive]

JLant - Thanks for the update. There is a pretty fascinating and thorough overview on their website (http://www.valvexchange.com/physicians/index.html) of the various pursuits (past and current) for a true replacement heart valve "game-changer" (such as a tissue valve to last a lifetime, a mechanical valve that doesn't require anticoagulation, or an anticoagulant without side effects) in the context of their own technology. It's still easy to be skeptical, of course, but I think the good news for heart valve patients is that all of these options are being pursued and advanced, and no matter what option might ever come out on top, patients will only benefit in the end.

So here's wishing continued good progress to ValveXchange, as well as On-X, Edwards, etc...

 

[ElectLive]

Just a quick update: http://www.valvexchange.com/news/documents/ValveXchange_November_2012.pdf.

The first trial (very small patient group though) is now underway in Germany.