Why is Cardious developing an Aortic Valve Bypass Graft?

Short answer – we don’t think it is prudent to throw the baby out with the bathwater.

Now the longer answer.

Prior to starting Cardious, my partner Kem Schankereli and I were consulting for a stent valve start-up company.  After given the basic concept by the physician founder, our job was to design and build a working prototype of a catheter delivered expandable aortic heart valve.  With my background in interventional catheters and Kem’s in heart valves, we were well suited to the task.  After initial animal studies, it became apparent to us that a stent valve was a high potential concept, but packaged in a myriad of significant development challenges.  In our experience, we have come to understand the “zen” of a successful implantable medical device.  That is, the key to an implant product’s success is to leverage knowledge and experience to make the implant simple.

Stent valves and the related implant procedure are not simple.

While explaining the stent valve concept to my long time friend and prototype machinist Jack, he said “Why doesn’t a guy just bypass the plugged valve by creating a second pathway out of the heart?”  After a few simple sketches on his workshop table, the basic “simple solution” became apparent – use already proven, commercially available implant technologies in a different configuration and add a disposable cutting tool to create an “off pump” solution using “on the shelf” implant components!

After the initial euphoria common to inventors wore off, I did a Google search and found out there was already substantial clinical precedence for the procedure!  It is known to cardiac surgeons as an apico aortic conduit. I discovered a limited number of surgeons around the world already perform this life saving technique – except it is typically done “on pump”. Surgeons assemble grafts, a connector, and a valve together just prior to surgery. There are no approved products available.

Kem and I realized prior human use only adds to the “zen” of our product concept.  The basic physiology of an apico-aortic bypass graft has already been shown to be feasible. We can focus on “engineering” the “on pump” procedure into a safe and reliable “off pump” procedure.

Unlike stent valves, we will offer the cardiac surgeon an “off pump” solution that can use any one of multiple  commercially available prosthetic heart valves already proven to be safe and reliable based on decades of serious study.

That is the story behind why we are developing an Aortic Valve Bypass Graft.

We want to provide the cardiac surgeon the implant and tool required to provide the patient an “off pump” implant procedure while still using the the world’s safest, most trusted artificial heart valves.

Why throw the baby out with the bathwater?

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