J&J’s NaviStar for atrial fibrillation gets FDA nod
POSTED February 9, 2009 - 11:57 | POSTED BY Jyoti Pal
Last edited by Shikha Patial on February 9, 2009 - 12:09
New Jersey, February 9: Johnson & Johnson unit Biosense Webster got a nod from the Food and Drug Administration (FDA) Friday to sell a device known as the ‘NaviStar Thermo Cool’ catheterdefine. The device is used in the treatment of the common heart-rhythm disorder ‘atrial fibrillation’.
With the approval in its kitty, Biosense Webster will compete with the likes of St. Jude Medical Inc., Medtronic Inc. and Boston Scientific Corp. and vie for a share in an already fast-growing cardiacdefine medical device market. Analysts claim that the heart-ablation market may reach $2 billion in annual sales by 2011.
As per the U.S. National Institutes of Health, atrial fibrillationdefine, a common rhythm disorder, affects more than two million Americans. Chances of strokes, heart failure and other complications in patients increase as the heart's upper chambers beat at a high-speed and in a disorderly manner.
Aaron Vaughn, an Edward Jones & Co. analyst in St. Louis opined that Ablation is "the hot, sexy area of cardiac medical devices right now. There’s a lot of potential, since there’s no pharmaceutical product out there right now that addresses a-fib particularly well."
Normally, drugs are the administered to a typical atrial fibrillation patient. If recurrently used, these drugs do not help. The Biosense Webster device use catheters that are introduced through a blood vessel and directed to the heart. These catheters vigilantly obliterate heart tissue connected to the problem.
Atrial fibrillation may be an unrelenting continual problem or it can assume an intermittent character. Biosense Webster’s NaviStar Thermo Cool device, which is outfitted with a navigational system to guide doctors through three-dimensional images of the heart, has been approved for "paroxysmal" atrial fibrillation.
In case of paroxysmal atrial fibrillation, the warning signs of the problem occur intermittently and the cure entails creation of a circular scar that blocks signals from the pulmonarydefine veins.
