Great News for Aortic Valvers

[Marty]

Medtronic buys two heart-valve manufacturers.
The Wall Street Journal (2/24, B3, Kamp) reports that "Medtronic, Inc. agreed to pay at least $1.03 billion to buy two closely held makers of replacement heart valves that don't require major surgery, taking the medical-device maker into a nascent market and fueling a rivalry with Edwards Lifesciences Corp." The two purchases, "for CoreValve, Inc. and Ventor Technologies, Ltd., could help Medtronic offset sluggish conditions in its biggest business -- implantable heart defibrillators -- and competitive pressure elsewhere." The devices the companies manufacture "are replacements for the aortic valve, which sends blood from the heart's main pumping chamber. The aortic valve can become narrow to the point at which it impedes blood flow, in which case patients may need a replacement."

Minnesota's Star Tribune (2/24, Moore) notes that both companies "are developing new ways to replace heart valves in patients." Scott Ward, president of Medtronic's CardioVascular division, said, "Surgery to replace aortic valves is very successful; patients who have their valves replaced do quite well. ... But there are patients now who are not surgical candidates."

The AP (2/24) explains that Corevalve's "technology has been implanted in 2,600 patients worldwide, though it has not yet been cleared for use by the Food and Drug Administration. Rather than performing open-heart surgery, the company's system allows a surgeon to insert a replacement heart valve through a small incision in the leg artery." Meanwhile, "Ventor Technologies' products are especially designed for patients with heart valves that don't open completely, but who are too sick to undergo surgery. Medtronic estimated about 300,000 people worldwide have the condition." The Financial Times (2/24, Arnold), Bloomberg News (2/24, Nussbaum), the Memphis Business Journal (2/24, Vomhof), and Modern Healthcare (2/24, Blesch) also cover the story

 

[Braveheart]

Edwards, which sells its $30,000 Sapien valve in Europe, is the only company with a minimally invasive valve in human trials in the U.S. The company has said it expects U.S. Food and Drug Administration approval as soon as 2011.

http://www.bloomberg.com/apps/news?pid=20601087&sid=aZPbwO8ssXCk&refer=home

Now this makes things more confusing for me.Six months ago, my cardio said that I had about three years before I had to have an AVR. I, on the other hand, wanted to have the procedure earlier, while my heart was still in excellent condition. Looks like the timing is right. If I can hang out until 2011, it may make my life a lot easier to have the new valve procedure. Then again, I don't know if I want to have a procedure where there is not much longitudinal experience.

 

[Mary]

It sounds very promising for those with aortic valves that need replacing.

 

[Jkm7]

Any advances of this sort are very good news IMO

 

[spartangator]

Wow, cool stuff. Hope this makes the procedure one step closer to outpatient.

 

[epstns]

Yeah, but so far they are saying that their valve is for patients who are too sick to undergo conventional surgery. Do we think that this percutaneous valve implant will ever replace or be an option to conventional valve replacement for the rest of us who "could" undergo conventional surgery?

 

[Ross]

Yeah, but so far they are saying that their valve is for patients who are too sick to undergo conventional surgery. Do we think that this percutaneous valve implant will ever replace or be an option to conventional valve replacement for the rest of us who "could" undergo conventional surgery?

It's like predicting the future. Too early to tell, but from the things I've read, it looks promising.

 

[ChouDoufu]

Yeah, but so far they are saying that their valve is for patients who are too sick to undergo conventional surgery. Do we think that this percutaneous valve implant will ever replace or be an option to conventional valve replacement for the rest of us who "could" undergo conventional surgery?

eventually, yes. there is money to be made. much money. they can make
a perc valve for 10% the cost, but sell it at say 50% of standard cost. and
think of all the valves that could be replaced, but....

....patient is too anxious to undergo traditional surgery
....insurance says its not critical (yet), so won't pay
....patient has no insurance, govt says can wait
....cardio says no symptoms, can wait a little longer
....other reasons i haven't thought of yet....

 

[Lynlw]

Yeah, but so far they are saying that their valve is for patients who are too sick to undergo conventional surgery. Do we think that this percutaneous valve implant will ever replace or be an option to conventional valve replacement for the rest of us who "could" undergo conventional surgery?

Most of the surgeons (and they don't even do them usually) that I listened to on the AATS conference webcasts, expect it to. During the end of the day round table panel after all the sessions on different Percutaneous valves, they were discussing how resident programs are set up and hybrid labs ect since this will be more and more common, so were trying to figure out the best way to go about how training should be.
I think the reason the trials are set up now on older or sicker people, is it is hard to get approval to do trials when there already is a pretty good solution to the problem (OHS) so they offer it to pateints that probably couldn't survive OHS. Right now the Pulm trials don't have the same criteria,about unoperable, (probably because the people in the right age (older than 5) already had 1 or more surgeries?)