Join        Login             Stock Quote

Edwards Lifesciences (EW): All Eyes On FDA Panel

 June 12, 2012 04:26 PM

(By Mani) A FDA Advisory Committee will review Edwards Sciences Corp.'s (NYSE:EW) pre-market approval for the Sapien transcatheter heart valve (THV) for use in high risk surgical patients on June 13.

The FDA is expected to focus on the transapical approach, stroke rates, paravalvular leaks/aortic regurgitation (AR), durability, valve-in-valve, and the post-approval study.

The market already expects a favorable outcome and for ultimate approval of Sapien valve along with the transfemoral and transapical delivery systems.

"We too believe the valve will be approved along with the systems, but believe there could be some risk on the timing of the transapical," Deutsche Bank analyst Kristen Stewart wrote in a note to clients.

[Related -St. Jude Medical, Inc. (NYSE:STJ): A Stock With Potential To Outperform Peers]

Meanwhile, the indication and label will be important given the National Coverage Determination (NCD) The bar was reset higher for the US launch following the results of the first quarter despite the company lowering its guidance to reflect a later than expected push out, as well as the final NCD decision.

The Centers for Medicare & Medicaid Services (CMS) will reimburse transcatheter aortic valve replacement (TAVR) procedures for U.S. patients with symptomatic aortic stenosis under specified criteria.

"We believe there are still some risks to the roll-out and near/medium term sales due to the NCD and the registry requirement," Stewart added.

[Related -Medtronic, Inc. (MDT): Turning The Beat Around?]

In addition, there will be more competition in Europe in the coming year with St. Jude Medical's (NYSE:STJ) expected launch of Portico as well as Medtronic's (NYSE:MDT) next-generation Evolut valve. Boston Scientific is also planning to launch a transcatheter valve, though the system may be less competitive than alternatives based on the data seen so far.

iOnTheMarket Premium


Post Comment -- Login is required to post message
Alert for new comments:
Your email:
Your Website:

rss feed

Latest Stories

article imageChart Says This Retailer's Comeback Isn't Finished

One of the surprises, at least on the surface, of the market's recent swoon was the outperformance of read on...

article imageETF Performance Review: Major Asset Classes | 19 Dec 2014

It’s all about real estate investment trusts (REITs) these days when it comes to bullish performance among read on...

article imageOil and Global Stock Markets Rebounding Sharply

So far so good on our expectation of a 4 to 5% pullback and then a resumption of the bull read on...

article imageGrading the FOMC

Love its members or loathe them, you have to admire the gradual impact the policy-making committee has had read on...

Popular Articles

Daily Sector Scan
Partner Center

Related Articles:

Optimism Moving Back Into The Equation
More Articles on: Medical

Fundamental data is provided by Zacks Investment Research, and Commentary, news and Press Releases provided by YellowBrix and Quotemedia.
All information provided "as is" for informational purposes only, not intended for trading purposes or advice. iStockAnalyst.com is not an investment adviser and does not provide, endorse or review any information or data contained herein.
The blog articles are opinions by respective blogger. By using this site you are agreeing to terms and conditions posted on respective bloggers' website.
The postings/comments on the site may or may not be from reliable sources. Neither iStockAnalyst nor any of its independent providers is liable for any informational errors, incompleteness, or delays, or for any actions taken in reliance on information contained herein. You are solely responsible for the investment decisions made by you and the consequences resulting therefrom. By accessing the iStockAnalyst.com site, you agree not to redistribute the information found therein.
The sector scan is based on 15-30 minutes delayed data. The Pattern scan is based on EOD data.