Shares of Edwards Lifesciences Corp. (NYSE:EW) continued to slide on Wall Street for the second straight day, despite positive earnings and a favorable FDA panel vote that should clear the way for the company to launch the Sapien transcatheter heart valve in the U.S..
Edwards Lifesciences
Shares of Edwards Lifesciences drop despite positive FDA vote
Shares of Edwards Lifesciences Corp. (NYSE:EW) were off by nearly 4 percent on Wall Street, despite a favorable FDA panel vote that should clear the way for the company to launch the Sapien transcatheter heart valve in the U.S.
Our polite new world of rationing
“To ensure rational and responsible dissemination of this new
technology (transcatheter aortic valve replacement [TAVR]), government,
industry and medicine will need to work in harmony.”– David R. Holmes, Jr., MD, FACC
President, American College of Cardiology
FDA: Edwards LifeSciences’ Sapien valve “increases survival and improves patient function” despite increased stroke risk
Updated: 7/19/2011 12:15 p.m.
The Sapien transcatheter heart valve, made by Edwards Lifesciences Corp. (NYSE:EW), seems poised for a favorable vote from an FDA panel, despite study results that show patients receiving the device have an increased risk of stroke.
St. Jude’s Ilumien hybrid wins CE Mark | Regulatory Roundup
St. Jude Medical Inc. (NYSE:STJ) landed CE Mark approval in the European Union for what it bills as the first and only hybrid diagnostic imaging system to combine optical coherence tomography and fractional flow reserve technology into a single platform.
The latest round of patent spats for Medtronic and Edwards Lifesciences
First successful artificial lung use for a toddler staves off transplant for more than a year | Research roundup
Two-year-old Owen Stark became the first toddler successfully treated with an artificial lung, managing to avoid the need for a transplant more than a year later.
Owen arrived at St. Louis Children’s Hospital in the summer of 2010 near death from heart failure and dangerously high blood pressure in his lungs.
Edwards Lifesciences: U.S. Sapien launch could beat Europe
Edwards Lifesciences Corp. (NYSE:EW) is confident that its flagship Sapien transcatheter heart valve device will have a quicker uptake in the U.S. than it did in Europe.
Speaking at an investors conference in Boston, Edwards’ vice president of investor relations David Erickson said the company has several advantages in the U.S. market that it didn’t have when it launched the Sapien device in Europe four years ago.
Edwards LifeSciences: Sapien panel date set for July 20
Edwards Lifesciences Corp. (NYSE:EW) will get its much-anticipated date with the FDA for its flagship Sapien transcatheter heart valve device on July 20.
Court favors Edwards Lifesciences in 20 year consulting quarrel
Edwards Lifesciences Corp. (NYSE:EW) gained ground on a case involving a former cardiac consultant who claimed that the medical device giant owed more than $3 million for using the consultant’s name in marketing materials.
Medical device makers spend $620k on 2011-2012 election cycle
Medical device makers dropped at least $623,250 on the 2011-2012 election cycle, according to a MassDevice examination of a federal database that tracks corporate donations to legislators and political actions committees, known as PACs.
Abbott Laboratories (NYSE:ABT) alone accounted for more than 45 percent of the donations, spending a total of $282,000 — nearly $100,000 to individual members of Congress and the rest to various PACs, according to the Federal Election Commission’s online database.