Medical blog » NaviStar

J&J’s “NaviStar ThermoCool” Gets a Nod from FDA

admin — Fri, 06 Feb 2009 07:22:13 +0000

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.

Biosense wins FDA approval for Navistar Thermocool catheter

admin — Thu, 25 Dec 2008 07:12:20 +0000

The FDA approval is based on results from a multicenter study comparing catheter ablation to drug therapy for the treatment of atrial fibrillation (AFib). In this randomized clinical trial, catheter ablation was shown to significantly outperform anti-arrhythmic drug therapy for the treatment of drug refractory recurrent symptomatic paroxysmal AFib.
The approval by the FDA also includes the EZ Steer Thermocool navigational catheter, which is a bi-directional version of the catheter. These catheters are compatible with 3-D mapping systems which recognize the Carto system magnetic location sensors. These include the Carto, Carto XP, and Carto 3 EP Navigation Systems, the company said.
The Navistar Thermocool catheter is also approved in the US for the treatment of Type 1 atrial flutter, and recurrent drug/device refractory sustained monomorphic ventricular tachycardia due to prior myocardial infarction.
Marcia Yaross, vice president of clinical, regulatory and health policy at Biosense Webster, said: “This decision by the FDA recognizes the safety and effectiveness of Navistar Thermocool catheter ablation for the treatment of paroxysmal AFib and gives the medical community another treatment option for many patients whose often debilitating symptoms are not effectively managed through medical therapy.”

Biosense wins FDA approval for Navistar Thermocool catheter

admin — Wed, 13 Feb 2008 14:29:26 +0000

Feb 09, 2009 (Datamonitor via COMTEX) –
— Biosense Webster, a Johnson & Johnson company, has received marketing approval from the FDA for its Navistar Thermocool catheter for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with compatible three-dimensional electroanatomic mapping systems.
The FDA approval is based on results from a multicenter study comparing catheter ablation to drug therapy for the treatment of atrial fibrillation (AFib). In this randomized clinical trial, catheter ablation was shown to significantly outperform anti-arrhythmic drug therapy for the treatment of drug refractory recurrent symptomatic paroxysmal AFib.
The approval by the FDA also includes the EZ Steer Thermocool navigational catheter, which is a bi-directional version of the catheter. These catheters are compatible with 3-D mapping systems which recognize the Carto system magnetic location sensors. These include the Carto, Carto XP, and Carto 3 EP Navigation Systems, the company said.
The Navistar Thermocool catheter is also approved in the US for the treatment of Type 1 atrial flutter, and recurrent drug/device refractory sustained monomorphic ventricular tachycardia due to prior myocardial infarction.
Marcia Yaross, vice president of clinical, regulatory and health policy at Biosense Webster, said: “This decision by the FDA recognizes the safety and effectiveness of Navistar Thermocool catheter ablation for the treatment of paroxysmal AFib and gives the medical community another treatment option for many patients whose often debilitating symptoms are not effectively managed through medical therapy.”

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