There seems to be a new precedent. Instead of trying to have everyone use your new product, we have a company that is deciding who can use this already approved product. Is that because the product is harder to install that we think- or because the manufacturer is trying really hard to control any potential negative publicity?
Edwards Laboratories was started by Lowell (nee Miles) Edwards in 1958, with the first commercially available heart valve (Starr-Edwards mitral valve). It became part of American Hospital Supply Corporation 8 years later, and then became part of Baxter (now Baxter International) when AHSC was acquired in 1985, was spun off yet again as a separate public company (Edwards LifeSciences) in 2000. Now, its new valve, the Sapien (reported on this blog here in June 2011), 12 years in the making (and about $ 1 billion in development costs). does not require open-heart surgery for its installation. The goal is to treat 250K patients (14000 who die from aortic valve disease) annually.
Maybe this is why Edwards is not willing to “satisfy” the market demand, and is, instead, determining which physicians and hospitals meet its criteria to use the product. This requirement also includes a fair amount of investment on the part of the hospital. Which also explains why Edwards is taking a beating in the stock market- sales of Sapien were below market expectations so far, at about $ 17 million; they should reap some $250 million this year. (The corporate goal is to achieve some $ 2 billion in sales, with ½ derived from non-US sales.)
Since the device costs about $ 30K a pop, it means about 8000 units are projected to be sold this year (less than 1/30 the annual US requirements). But, the device is limited in application, right now, only to those patients too ill for open heart surgery, since there are significant potential risks to this device (stroke, among them). And, it seems that a new procedure, inserting the device via a small incision under the ribcage via catheter, may be a little tricky. Edwards hopes by perfecting the installation process and training the physicians, side-effects will be minimal and wide-spread use could ensue.
Which could also help its competitors- Medtronic, St. Jude, and Boston Scientific- who expect to have devices for sale in the US within two years (and sooner overseas). But, most of all, one hopes it helps the patients who will benefit from these valves- without open heart surgery.
I find this information very interesting because my father died of heart disease in 2010. He had open heart surgery in 2007 (5 blockages) and had a massive heart attack in August, 2010. He survived this heart attack but the doctors said that his heart valves were leaking and he was too sick to survive the surgery. So…he went back home and lived another 3 months taking lots of medication. I wish this product would have been available to my daddy….maybe other lives will be saved.
Janette Fuller recently posted..Handmade Baby With A Bunny Card
Janette- so sorry about your father. One can only hope that these valves will become widely available and affordable – soon!
I just watched a television show that informed me that people can move up organ transplant lists based on how much money they give the hospital and sometimes people who are rich or famous can move up even faster. So I have no doubt about who will get these precious new devices. And it has everything to do with money.
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Well, these devices ARE expensive, Ann. Maybe folks should have paid more attention to the clauses of PPACA, which would mean that insurance companies have no means to put a cap of treatments…
Roy