J&J’s "NaviStar ThermoCool" Gets a Nod from FDA

Washington, February 9: Johnson and Johnson (JNJ) has finally got a green signal from The Food and Drug Administration (FDA), to market a device that could be a potential cure for the common heart-rhythm disorder called atrial fibrillation. This is the first ever approval given by the FDA for a device of this kind.

The news is welcomed by the already booming device market. As per the estimations made by JPMorgan analyst, Michael Weinstein the atrial-fibrillation market reached $1.6 billion in 2008 after growing by about 16 percent.

Daniel J. Starks, St. Jude's chairman and chief executive, said at an investor conference on Friday, “Atrial fibrillation represents the best growth opportunity in medical devices here in the near term."

As an instant reaction to the approval, the shares of J&J, which is a Dow Jones Industrial Average component, recorded a rise of 40 cents to reach $58.51 on Friday.

The device will be marketed by J&J's Biosense Webster by the name “NaviStar ThermoCool” catheter and is expected to bring much relief for patients suffering from atrial fibrillation, who did not show a favorable response to treatment through drugs. Atrial fibrillation is a common rhythm disorder that presently affects about two million people in America.

People might suffer from an atrial fibrillation that occurs occasionally or the one that is persistent. Atrial fibrillation is a rhythm disorder that results into abnormally fast and disorderly beating in the heart's upper chambers. This ailment is known to enhance the risk of strokes, heart failure and may lead to other complications if not addressed in time.

The device developed by Biosense Webster is capable of treating "paroxysmal" atrial fibrillation, a variation of atrial fibrillation where symptoms occur occasionally. This requires a treatment which involves making tiny burns that result into circular scars that can block the signals from the pulmonary veins.

FDA’s approval is based on the results of a clinical study of 167 patients. The study revealed that the device is effective in eliminating recurrence of atrial fibrillation episodes for one year in approximately 63 percent of treated patients in comparison to 17 percent of the patients who received drug treatment.

Biosense Webster happens to be the first device of its kind to get the official approval where competitors include big names like St. Jude Medical Inc. (STJ), Medtronic Inc. ( MDT) and Boston Scientific Corp. (BSX).

Until date patients suffering from the malady were subjected to drug treatment which usually failed to produce the desired results. Biosense Webster’s “NaviStar ThermoCool”catheter uses catheters inserted through a blood vessel and guided to the heart, to carry a radio-frequency current to burn, or ablate heart tissues associated with the ailment.

Even though this device is the first ever catheter for atrial fibrillation to be approved by the FDA, there are already plenty of devices already being used for the purpose. These devices had earlier been approved for some other purpose. Doctors have been using them in spite of a threat of scrutiny from federal authorities.