Edwards’s Win Yields Therapy for Frail Heart Patients

[ks1490]

good news for tissue valvers....

Edwards’s Win Yields Therapy for Frail Heart Patients (Update2)2010-09-23 20:22:23.972 GMT
By David Olmos and Michelle Fay CortezSept. 23
(Bloomberg) -- Edwards Lifesciences Corp.’s Sapienheart valve may become the first life-saving treatment in theU.S. for frail, elderly patients with diseased valves after astudy found it slashed deaths in those with few medical options.Edwards rose $7.89, or 13 percent, to $67.59 at 4 p.m. inNew York Stock Exchange trading, in the biggest single-dayincrease since July 2002. The company’s shares have doubled inthe past 12 months as investors anticipated yesterday’s studyresults.

Edwards, based in Irvine, California, will use thisresearch and additional tests in healthier patients to seek FDAapproval of the $30,000 valve next year. If Sapien is safer andworks as well as alternatives in a broader group of patients,Edwards may double sales to $2.8 billion in five years, analystssurveyed by Bloomberg projected.“The overall data is stronger than we expected,” JasonMills, an analyst with Canaccord Adams Inc. in San Francisco,said in a telephone interview. “This moves the ball down thefield with respect to this technology.”

 

[NealR]

This is terrific news. As a EW valve reciepient, I have been watching this for a few months. My Cardiolist hinted that a major change was in the works for this type of valve replacement. He further advised, as a former proponent of mechanicals valves (for people under 60), says this is a significant game changer. The best news, he went to advise, is yet to come. The prospects of replacing valves (re-do's) via this method appear to be the direction the medical industry is headed.

Stupid me, when I had my surgery done last October, the stock was trading around $30 something a share!

 

[BAVD John]

I believe my surgeon may have been involved in the study. He told me before my surgery that he had done transcatheter valve replacement on older patients. He also stated that he thought my next replacement could possibly be done by transcatheter. It will be interesting to see how this market develops and if it will be only used on older patients or open as an option to all patients needing valve replacement.

 

[Lynlw]

I believe my surgeon may have been involved in the study. He told me before my surgery that he had done transcatheter valve replacement on older patients. He also stated that he thought my next replacement could possibly be done by transcatheter. It will be interesting to see how this market develops and if it will be only used on older patients or open as an option to all patients needing valve replacement.

Yes Northwestern is one of the locations taking part in the trials...Pretty much most of the bigger Centers are now http://clinicaltrials.gov/ct2/show/study/NCT00530894?term=sapien&rank=2&show_locs=Y#locn
I guess they all want to have experience when it is approved by the FDA. The HOPE is eventually for all patients who are candidates for it, but I don't know when that will happen.
The pulmonary one (Melody made by medtronic) was approved for general use a few months ago, but there are much fewer people who need pulmonary valves replaced..

 

[ks1490]

The key for us younger folks is the PARTNER II trial, which the FDA just approved and was a big part of the stock surge. The PARTNER II trial will determine if they can open up the transcatheter replacement to a broader universe of patients (i.e., young, otherwise healthy people).