St. Jude EPIC VALVE ??

[Jims]

My Surgeon offered to allow me to participate in the FDA clinical trials for a valve called the St. Jude EPIC bioprosthetic valve.

This valve has been used in Europe for nearly 19 years. I was wondering 2 questions:
1. does anyone know anything about this valve
2. Is it a smart thing to particpate in a clinical trial like this.

I am now 57 so if I choose a tissue valve it will probably fail in 15-20 years. I will be 77 if it lasts 20. Ii I get a this EPIC and it last say 25, then I will be 83 when it needs replacement.

Surgery at 57 is going to be no fun, but is it worse to have surgery at 77 compared to 83 ?

Thanks,
Jim

 

[Rich]

Jim,
Valve selection is always a tough choice, and a very personal one also.
I was 58 when I had my AVR.
My surgeon told me I was too young for a tissue valve.
So I ended up with a St. Jude Mechanical.
It has been over eight years since then and the valve seems to be working great.
As far as Coumadin goes, yes it is a pain.
Monthly testing doesn't bother me, but having other invasive procedures is very difficult due to the Coumadin.
I was told this valve could or should last 30-35 years.
None of us know what the future holds when it comes to our health.
At age 77 things could be far different than today and another valve surgery could be very tough.
With all that in mind I understand the hard choice you are facing.
Rich

 

[KathyH]

Jim,
Here is some info from the St Jude's site.






News Release

St. Jude Medical Announces First North American Implant of the SJM Epic Supra Valve Following Canadian Regulatory Approval
ST. PAUL, Minn.--(BUSINESS WIRE)--July 19, 2004--St. Jude Medical, Inc. (NYSE:STJ) today announced the first North American implant and Canadian regulatory approval of its SJM Epic(TM) Supra valve. The implant was performed by Robert Cossette, M.D., Chief of Cardiac Surgery at Sacre-Coeur Hospital in Montreal, Quebec, Canada, on a 68-year-old man who was diagnosed with aortic valve stenosis (narrowing). The operation was successful and the patient is doing well.

The SJM Epic(TM) Supra valve is an aortic supra-annular stented porcine tissue valve. (A supra-annular valve is implanted above the annulus, which is a supporting structure around the aortic valve leaflets.) The valve design is based on the same platform as the SJM Epic(TM) valve, which began U.S. clinical trials in January 2003. Both the SJM Epic(TM) valve and SJM Epic(TM) Supra valve are based on the design of the SJM Biocor(TM) valve, which has a documented 20 years of clinical use and 15 years of proven durability. In addition, the SJM Epic(TM) valve and SJM Epic(TM) Supra valve feature the Company's proprietary Linx(TM) anticalcification technology.

The SJM Epic(TM) Supra valve was designed with an optimized stent to native annulus ratio to provide excellent hemodynamic performance. In addition, the sewing cuff and the low-profile stent are designed for ease of implant in the supra-annular position. The SJM Epic(TM) Supra is available in aortic sizes ranging from 19 mm to 23 mm.

Stented tissue valves are becoming an increasingly important part of the heart valve market, representing about 45 percent of the U.S. heart valve segment. The SJM Epic(TM) Supra expands St. Jude Medical's stented valve product offering, providing additional options for the Company's physician customers and their patients.

The SJM Epic(TM) Supra valve was commercialized in Europe in October 2003. Both the SJM Biocor(TM) and SJM Epic(TM) valves are currently available in Europe, Canada, Latin America and Asia.

"We're pleased to introduce the SJM Epic(TM) Supra valve to the Canadian market, underscoring our commitment to enhance our stented tissue valve portfolio," said Jane J. Song, President of St. Jude Medical's Cardiac Surgery business. "The SJM Epic(TM) Supra valve complements our SJM Epic(TM) and SJM Biocor(TM) stented valves, offering a supra-annular option to our physician customers."

Any statements made regarding the Company's anticipated future product launches, regulatory approvals, revenues, earnings, market shares, and potential clinical success are forward-looking statements which are subject to risks and uncertainties, such as those described in the Financial Section of the Company's Annual Report to Shareholders for the fiscal year ended December 31, 2003 (see pages 11-16). Actual results may differ materially from anticipated results.

St. Jude Medical, Inc. (www.sjm.com) is dedicated to the design, manufacture and distribution of innovative medical devices of the highest quality, offering physicians, patients and payers unmatched clinical performance and demonstrated economic value.


CONTACT: St. Jude Medical, Inc., St. Paul
Investor Relations:
Laura Merriam, 651-766-3029
or
Media Relations:
Peter Gove, 651-481-7790

SOURCE: St. Jude Medical, Inc.












© 2004 St. Jude Medical, Inc.

 

[Jims]

Thanks Kathy,

I think I have amde up my mind (somewhat!!). I think I will stay away for the St. Jude clinical study and I am leaning toward an edwards pericardial or the Magna.

Surgery is day after tomorrow (Sept 15th). Strangely through the help I have received on this site, don't feel as scared as I thought I would!

I am just waiting the improvement that I am hoping for.

Jim

 

[tobagotwo]

I am relieved to read that you are backing away from that study.

St. Jude describes their tissue valves as having a life of 5-15 years, and cites 15 years as a good life for a xenograft valve. They have added an anticalcification process to the valve. They don't seem to have any studies from their "20 years of experience" in Europe. I would think they'd be posting the numbers and bragging, if they were worth printing.

The old version of the CEP bovines was studied after 18 years, with 80% being still in use. Now, they add anticalcification, and low-pressure processing. If you want longevity in a tissue valve, the CEP models would seem to be the way to go.

While its configuration is slightly different, the CEP Magna is expected to last just as long, and offers even more advantages as far as hemodynamics (bloodflow). The goal for Edwards with all of these CEP-series valves is 25 years of life. They will likely average at least 20-22 years in patients over 45 (entirely my gut estimate, compensating for their marketing enthusiasm).

The Medtronics Mosaic is an excellent valve, with excellent hemodynamics. The "old" model went 15-18 years in the over-45 crowd. Now, they add anticalcification and Zero-G fixation processing, which avoids damaging the leaflets, a cause of calcification and failure. They are also looking for 25 years from their improvements to the valve. I suspect more like 20. Still very good.

For me, who received it at 51, 20 years means resurgery at a reasonable age. It's not always just how long the valve will last: sometimes it's a strategy thing.

Another thing to consider is that there will likely be improvements in the valves, and maybe also in the delivery during the next twenty years. While it is in its infancy, percutaneous implantation is already being tried.

Best wishes,