FDA approval, SJM 'Regent' valve

[LUVMyBirman]

"Information' contained in the article is purely the opinion of the manufacturers and must be read and consumed as such".

St. Jude Medical Gains FDA Approval For Next-Generation Mechanical Heart Valve


ST. PAUL, Minn.--(BUSINESS WIRE)--March 5, 2002--St. Jude Medical, Inc. (NYSE:STJ) today announced it has received U.S. Food and Drug Administration (FDA) approval for the SJM Regent(TM)heart valve, the newest product in the Company's "gold standard" line of mechanical heart valves.

Maintaining the fundamental features found in St. Jude Medical's industry-leading mechanical heart valve products, the SJM Regent(TM) heart valve offers exceptional structural integrity, durability and low complication rates.

The SJM Regent(TM) aortic heart valve features subtle design modifications to the valve's pyrolytic carbon components, resulting in unprecedented hemodynamic performance. This translates into single-digit pressure gradients - even in valves as small as 19 mm.

"Our experience with the SJM Regent(TM) heart valve has demonstrated a new standard for hemodynamic performance," said Dr. Marc Sakwa, principal investigator at William Beaumont Hospital in Royal Oak, Michigan, the leading U.S. medical center for the SJM Regent(TM) heart valve clinical trials. "The outstanding hemodynamics resulted in a significant reduction of left ventricular (LV) mass in our patients. We believe this will contribute to better survival and improved long-term patient outcomes."

The SJM Regent(TM) heart valve has been marketed in Europe and Canada since 1999. Due to strong customer demand, this valve now makes up a significant percentage of St. Jude Medical's aortic valve sales mix in the international markets where it is available.

 

[Billy]

Let's be REALISTIC !!!!!

Let's be REALISTIC !!!!!

The above post is a recent marketing/publicity/press release from St. Jude Medical. Below is a similar type document from back in March 1998. I would urge those folks on this forum who are at the stage of making a decision on which valve to choose, to interpret all propaganda of this nature with a very open mind.

What is not widely publicised, is the clinical testing, or perhaps lack of clinical testing carried out on new St Jude products before they are released on to the market. It would appear from my investigations that more of a 'theoretical' testing is done prior to manufacture but many of the practical effects of these products are not fully realised until the valves are actually implanted, often into unsuspecting human guinea pigs.

Furthermore, possibly due to the fact that punitive damage claims are a luxury afforded to residents of USA, (and not to Europeans) these new products are sent to Europe, presumably for initial testing before being submitted to the FDA for approval. I'm not yet sure who approves them in Europe, but I intend to find out and work diligently to put a stop to such products being sent here for evaluation. It would appear that Canada is sometimes 'subjected' to these 'pre FDA approved' products also.

As the surviving spouse of one who was an early, unsuspecting guinea pig for a lethal St. Jude silzone coated valve, may I make a few comments which may prove prudent for others to consider.

All 'new' products should be thoroughly and impartially investigated with regard to all aspects of their proven effectiveness. In the past this has been difficult to achieve, but with the onset of the Internet, maybe this task will be easier to execute in the future.

Publicity propaganda like we read above should only be taken for what it is worth - i.e. a marketing exercise for a company with the prime objective of making a good financial return for both it's employees and it's shareholders.

And to St Jude.........

First I would urge you to consider that you are dealing with people's lives and the lives of your 'customers' loved ones - i.e. those who have to attend the funeral and who must try to carry on with life in a state of grief.

Secondly - when someone dies following implantation of one of your 'new' products and where there is any possibility that this product is in any way inefficient in it's work, at least carry out some investigations into why the death occurred. Don't just sit there and ignore it as if nothing had happened and then continue to implant thousands more in the hope that things will magically sort themselves out.

And thirdly, speaking as a European, unless you are prepared to afford all your customers, world-wide, an equal degree of responsibility, keep your crappy 'prototypes' in Minnesota and don't send them to us.

I attach the St Jude publicity for the 'silzone' valve which was published in March 1998. A product which eventually must rate as the biggest single disaster in it's field. Some recipients died, some needed second and even third surgeries and those who have so far remained unscathed, live every day with the fear of the distinct possibility of one or all of the above. This is reality, so lets keep all propaganda of this nature in it's proper perspective, and remember that even the FDA can get it wrong sometimes.

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St. Jude Medical Receives FDA Approval for the St. Jude Medical Mechanical Heart Valve SJM Masters Series With Silzone Coating
Issue: March 26, 1998

ST. PAUL, Minn., March 26 /PRNewswire/ -- St. Jude Medical, Inc. (NYSE: STJ) announced today it has received U.S. Food and Drug Administration (FDA) approval of the St. Jude Medical(R) mechanical heart valve SJM(R) Masters Series valve with Silzone(TM) coating. The St. Jude Medical trademark "Silzone" represents a proprietary metallic silver coating which is applied to the valve sewing cuff.

To date, more than 2500 SJM(R) Masters Series valves with Silzone(TM) coating have been implanted worldwide. In Europe, sales of the SJM(R) Masters Series valves with Silzone(TM) coating now represent almost one quarter of the Company's mechanical heart sales. In Canada, acceptance of the new product has been particularly rapid, with SJM(R) Masters Series valve with Silzone(TM) coating now constituting approximately 70% of the Company's mechanical valve sales.

The Silzone(TM) coating has been shown in laboratory tests to reduce attachment and colonization of microorganisms commonly associated with prosthetic valve endocarditis, a serious infection that can occur in a small percentage of patients following heart valve surgery. While the results of the laboratory tests are encouraging, clinical studies have not been performed to evaluate the effect of Silzone(TM) coating on reducing the incidence of prosthetic valve endocarditis.

Commenting on the FDA approval of the SJM(R) Masters Series valve with Silzone(TM) coating, Terry L. Shepherd, President of St. Jude Medical Heart Valve Division, said, "This FDA approval is another milestone in the commercialization of this important product. The acceptance of the St. Jude Medical(R) mechanical heart valve with Silzone(TM) coating has been very positive in international markets. We are pleased that we are now able to offer this innovative technology to our U.S. customers. It is part of St. Jude Medical's mission to offer the best solutions for heart valve disease to our customers and their patients."

St. Jude Medical, Inc. ( www.sjm.com ) develops, manufactures and distributes medical devices for the global cardiovascular market. The Company serves patients and its health care customers worldwide with the highest quality products and services including heart valves, cardiac rhythm management systems, specialty catheters and other cardiovascular devices.

 

[Nancy]

Just wanted to say that Joe has a Bjork-Shiley valve. This manufacturer also had a major disaster when the welds on some of their mechanical valves gave out, causing instant death. Several years ago, Joe and I were watching 60 Minutes, and we heard the story. We were petrified. Joe had lost the model number of his valve, and the records were not available. He had to go to Lahey Clinic to have a very powerful xray to determine the configuration of the valve, so they could put a model number to it. It wasn't in the defective group and he still has it. But it was a very anxiety producing thing to hear about.

This manufacturer is no longer doing business here in the States, I don't know about other places though.

Then when the story came out about the St. Jude valve, I had to do some research on his mitral valve. But we did have the model number and it is not a silzone.

Very sorry about your wife, Billy. What a tragedy. God be with her and with you.

 

[LUVMyBirman]

100% Agreement. I posted this thread just for informational purposes. Just because we have an FDA approval on something....DOES NOT mean it is safe for the consumer. There is another tissue valve that has been under the microscope recently. That's a story I am sure most of us are aware of.

It is very unfortunate that something of this magnitude is not tested more thoroughly. And, furthermore uneducated patients going in for first time valve replacement are not being made aware that these are 'new technologies'. And very contreversial.

Will fully admit....that I was one of them. Did minimal research prior to my MVR. If I only knew then.....what I know now. Theoretically, if I were not in a 'Medtronic' research hospital at the time of my surgery. I am fully convinced that I too would have been a Silzone recipient. From what I have read, the mitral valves were the most susceptible to failure.

My heart goes out to those whom have been effected by this tragedy. May you find peace and justice.

 

[Billy]

Thank you.........

Thank you.........

Thank you Nancy and Gina for your replies.

I fully realise that the original post on this thread was posted here purely for information purposes and was probably done with the best intentions. If we look at the situation realistically we will surely realise that this is not 'information' as such, purely a speculative press release giving a totally biased assessment of the qualities of the valve mentioned.

As such it is dangerous to peddle so-called information of this nature as its very appearance here on a 'help' forum appears to give creedence to the product's capabilities. If a similar situation had arisen in 1998 and such 'information' had been used in someone's decision-making process as to what valve to have, I'm sure they would not be too happy about the eventual outcome of their decision.

I think therefore that it might be wise to preface any propaganda of this nature with a warning that the 'information' contained in the article is purely the opinion of the manufacturers and must be read and consumed as such.

It might also be best to leave out the final 'peaches and cream' paragraph from the St Jude Publicity department that St. Jude Medical, Inc. (www.sjm.com) is dedicated to the design, manufacture and distribution of medical devices of the highest quality, offering physicians, patients and payers unmatched clinical performance and demonstrated economic value.

At this stage I am not questioning their dedication in this respect. What I am questioning and will continue to question for a long time to come are, first of all their methods of testing, and secondly the distinct difference in their very efficient 'marketing' approach compared to their distinct lack of after-sales service and resulting denial of responsibility.

Seems like they are only interested in their success stories and their financial figures at the end of the year. Sad, but I suppose sometimes it just happens that way.

 

[LUVMyBirman]

Billy, I agree with your statements

"information' contained in the article is purely the opinion of the manufacturers and must be read and consumed as such".

Actually, I feel we should have a disclaimer of this sort attatched to the site, and or each post.

We all give a lot of informative personal advice here on the site. Though, it places our minds at ease........it should not replace physician consultation.

Hank, what do you think?

 

[DickV]

Gina, I agree with you. Some of the information I read, given as advice amounts to scary and people should read and accept it as people's individual opinions not medical advice, especially in the choice of valves.

Any new product has its problems and these are rarely mentioned by the manufacturer. For example, when some bi-leaflet valves came out in the 1970's, there were many deaths associated with these but none related to the function of the valves. The valves funtioned as designedd. Clotting was the culprit and it took much trial and error to figure out to manage same via anti-coagulants. I read that at first, some were just given asprin and many of these had complications and some of them died. Moral of the story is that many mechanical valves have no records of defects but the mortality rate is higher in the beginning because of other unknowns. I expect this is the case with most new valves. I played the adds which is why I went with a known valve and known complication issues. Both have to be considered.

 

[Hank]

I agree with Billy

I agree with Billy

I agree with you Billy. In fact, I have edited Gina's original post to reflect the changes you spoke of.

When we do a cut and paste of information that we feel would be helpful to others, we should all try to remember to note it as "informational" only.

Thank you to all of you my friends for making this a learning experience for all of us.

 

[Billy]

Thank you to all of you for your responses. Each of us have interpreted the subject of this thread in a slightly different way, which is interesting and 'healthy.'

We are all individuals and as such are often inclined to believe that we are right and that everyone else should concur with our views. That is dangerous and 'unhealthy.'

I am not 'informed' in Internet law. In fact I imagine that new legislation is being quickly implemented every day as it becomes necessary. However, in order to be ahead of the posse, and in an effort to safeguard the interests of VR.com members in general and Moderator Hank in particular, I feel that a disclaimer is important for a variety of both legal and individual reasons.

I have given some thought to this and my proposal below is simply written by a lay-man. Perhaps Dick, in his 'legal' role would be good enough to give it some consideration and suggest any necessary changes or additions.

Hope y'all agree that this is worth the effort. I'm a great believer in protecting the posterior at all times.

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DISCLAIMER - VALVEREPLACEMENT.COM

All information, advice and views expressed on this forum are the opinions of the individual writer and may or may not be shared by the Moderator and staff of Valvereplacement.com. Product suitability and medical advice given, should in all cases be checked and confirmed by a competent, suitably qualified member of the medical profession.
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[hensylee]

I vote. Know I have posted some stuff that might not be right, but it was my opinion at the time. Probably the rest of the members have done this, as well. A CYA statement is in order. God bless

 

[Marty]

To Janie

To Janie

Hi Janie, How is your valve doing? Does it still have that little leak you told me about a year or so ago. I know we were hoping it might not increase or even better close up.

 

[DickV]

Good start Billy,

I recommend the following:

All information, advice and views expressed on this forum, including but not limited to medical advice and product suitability, are the opinion of the writer and should not be interpreted or construed as legitimate medical advice. In all cases, information contained on this board should be checked and confirmed by competent, suitably qualified members of the medical profession. As such, Valvereplacement.com nor its members are responsible for the accuracy of the information, advice and views contained on this board.

 

[Perrster]

Good thinkin' Boys!

Good thinkin' Boys!

Dick,

How ya doin', man?

Excellent suggestion. FYI: The Mended Hearts (20,000+ members) REQUIRES a training course that specifically addresses such a topic and states that members are not allowed to give any such advice, in person or via their Internet Visitation programs. I took such training and never really got to use it in person, only via the Internet. I quit MH and chose to convert their (my) annual dues to vr.com.

I kind of thought vr.com was loosey-goosey on this, but hey, it's the Internet and it's free! I agree that we should tighten the reins and be more conscious of the who, what, when, where and how in what we say.

Cheers!

 

[Billy]

Thanks Dick.........

Thanks Dick.........

Hi Dick

Thanks for putting the 'flesh' on the 'bones' of my attempt at the disclaimer. As I said, mine was simply a lay-man's attempt to get the necessary points across.

Dunno what the situation is in the States but here we get these things checked and signed by a practising Solicitor just to be on the safe side. Then if something goes wrong we sue him and he has the necessary insurance to cover any claims for damages.

In this particular situation I think it could be argued that we have at least gone through the motions of taking precautions and have exercised reasonable skill and care in protecting the members of the forum.

I'm done on the subject now - It's up to the powers that be whether it is taken any further.

Whatcha think Hank?

 

[Hank]

Sounds wise

Sounds wise

It all sounds wise Billy - I'll get something put in place.

Thanks