Recently, I was asked why I thought our aortic valve bypass graft product is competitive compared to transcatheter products that are already in human studies. After some thought, below are the fundamental reasons why we think we have a good chance for success.
We believe a successful aortic valve surgery business should revolve around experienced surgeons [...]
Is data emanating from human transcatheter aortic valve trials showing clinical strength or weakness? Here is an example – you be the judge.
At the recent TCT conference in San Francisco, the midterm results of the PARTNER EU transcatheter valve study were presented. This study followed 120 patients implanted with the Edwards Sapien Valve.
Heartwire [...]
At Cardious, our goal is to move the aortic valve bypass graft procedure from a procedure performed only by
surgeons willing and able to source needed components (off label) and build the implant on the back table, to a predictable, easy to perform procedure using an approved device and tool. We will be successful when all [...]
I just added a new section to our website called Reference Materials. I have posted a few of the hundreds of references I have collected over the past few years on AVBG.
Dr. Gammie and group at the University of Maryland have a good paper summarizing the current state of the art.
Dr. Kerut and his colleagues [...]
In my last post, I argued that 40% of patients over age 70 presenting for AVR surgery with a stenotic aortic valve will have a bicuspid shaped valve and therefore will not be eligible for a transcatheter device. What about the 60% that have a tricuspid valve? Are all of these candidates for a transcatheter [...]
In my last post, I said that 40% of patients over age 70 presenting for stenotic
AVR (Aortic Valve Replacement) have a bicuspid shaped valve and that a bicuspid shaped aortic valve is a major contraindication to transcatheter valve implantation (reference PARTNER Trial and European Guidelines). Rationale for this contraindication can be found in a paper [...]
The answer is yes.
Our device can be viewed as both complementary and directly competitive to the new class of transcatheter valves being developed by Edwards, Medtronic, and others.
It is complementary because it can be implanted in patients that present with a bicuspid shaped valve – a condition strictly contraindicated for transcatheter valve devices. Even [...]
In an earlier post, I mentioned that a few years back my design consulting firm was involved in the development of a transcatheter valve device. Like my cartoon friend to the left, when I started the project I asked my client what were the design guidelines. Basically, the answer I received, which I think [...]
Last week we explanted the AVBG device we installed in a pig in October – approximately 120 day implant duration. The valve (25 mm Hancock II) inserted into the housing looked fully functional. We got some terrific echo data. A quick look at the internal housing via a boroscope indicated a normal pannus response. We did not open it. [...]
I am always asked – Why do you think the AvA Bypass Graft is a superior off-pump aortic valve procedure compared to stent valve procedures being developed by Edwards LifeScience , CoreValve, and probably a dozen smaller companies?
My short answer:
Superior risk management profile
Now for the longer answer.
LifeScience Alley, Minnestota’s medical device trade association, held its annual conference in Minneapolis on Dec. 10. We were fortunate to be selected as one of three New Technology Showcase Award Winners to present our story to the 1.500 attendees. Here’s the PDF of our 10-page PowerPoint presentation given by our Chief Technology Officer Kem Schankereli.
With the help of Master communications group, we recently produced an animation of the implant procedure. Click play to watch this 1 minute, 20 second animation, or download the Flash animation file.
Any questions or comments – please contact me. Remember, even though this general procedure has been performed in humans many times, our particular procedure [...]
On October 23, 2008, we successfully implanted our AvA™ Bypass Graft into a 100 kg pig. The graft was implanted by Dr. Lyle Joyce at the University of Minnesota, ESS animal research facility. Without any cardiopulmonary support, the device was installed through the 6th intercostal space into the left ventricle of a [...]
As I have mentioned, aortic valve bypass procedures are currently being performed by cardiac surgeons around the world. Using generally “on pump” techniques, surgeons employ components off label to create an integrated implant at the time of surgery.
A good example of the procedure basics is shown in a video recently posted on the CTSNet web [...]
Dr. James Gammie, a cardiac surgeon at the University of Maryland, has performed many AVBG (Aortic Valve Bypass Graft) procedures over the past few years.
Recently, Shelly Wood, a reporter for heartwire, did a story on his work in this area. The article is titled Aortic-valve bypass: A time-tested, minimally invasive alternative to valve-replacement surgery. I [...]
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 [...]
Welcome to the Cardious website… and this Cardious blog. My name is Jim Pokorney, and I am a founder and president of the company.
Within this site you will find a description of Cardious Inc., an emerging medical device company located in St. Paul, MN. Cardious is focused on the development of a less invasive aortic [...]