Full article reprinted from "The Gray Sheet" - October 20, 2008
Johnson & Johnson's chances of becoming the first firm to market an ablation device in the U.S. labeled for treating atrial fibrillation will be clearer next month, when the company is scheduled to present PMA supplement data to an FDA advisory panel.
Full article reprinted from "The Gray Sheet" - October 20, 2008
J&J Gets Panel Date Seeking First A-Fib Ablation Catheter Indication
Johnson & Johnson's chances of becoming the first firm to market an ablation device in the U.S. labeled for treating atrial fibrillation will be clearer next month, when the company is scheduled to present PMA supplement data to an FDA advisory panel.
The agency announced in the Oct. 15 1Federal Register that its Circulatory System Devices Panel will convene Nov. 20 to discuss and vote on J&J's submission for the NaviStar ThermoCool irrigated radiofrequency ablation catheter, manufactured by the firm's Biosense Webster unit.
If the panel recommends approval of updated labeling and FDA follows the advice, the firm could gain an edge in what competitors estimate to be a $2 billion atrial fibrillation market opportunity.
AF Approval Would Support Ablation Trend
ThermoCool was first 2approved for electrophysiological mapping and atrial flutter treatment in 2004. Since then, the catheter has also gained approval for monomorphic ventricular tachycardia. But atrial fibrillation (AF) is one indication that eludes the product - and all other ablation catheters on the market.
About 2.2 million people in the U.S. have AF, an irregular heart rhythm that accounts for about 15% of strokes, according to the American Heart Association. Drugs designed to control heart rhythm have been shown ineffective in extending the life of AF patients in many cases, leading physicians to increasingly employ ablation for AF, even though no devices have received FDA go-ahead for this use (3"The Gray Sheet" June 23, 2008, p. 21).
Some expect AF-specific approvals will accelerate use of ablation in this population, and that the first companies to gain AF labeling may be able to best capitalize on the growing market; others question whether the label will make much of a difference (4"The Gray Sheet" Feb. 4, 2008, p. 8).
The Circulatory System Devices Panel will consider the PMA supplement for ThermoCool to "ablate cardiac tissue for the purposes of creating lines of block in the atria to eliminate conduction patterns that theoretically generate or allow propagation of paroxysmal atrial fibrillation," the FDA notice states.
If approved, ThermoCool will be the first ablation device with AF labeling. But this will not be the first time the circulatory panel has reviewed AF ablation.
In 2003, the committee voted 7-0 to recommend against approval of Cardima's Revelation Tx microcatheter NavAblator ablation system for AF based on a single-arm, unblinded pivotal trial. The recommendation was heeded by FDA and later held up by the agency's Medical Devices Dispute Resolution Panel (5"The Gray Sheet" April 23, 2007, p. 14).
The panel has on multiple other occasions pressed the need for randomized trials to support an AF indication, despite difficulties cited by manufacturers and electrophysiologists in randomizing patients to a control group when drugs are increasingly perceived as ineffective (6"The Gray Sheet" Oct. 1, 2007, p. 9).
J&J's submission includes data from a randomized trial of AF patients, comparing ablation to anti-arrhythmic drugs. According to 7ClinicalTrials.gov, the study was slated to enroll 230 patients; the firm has yet to release additional details or results.
A-Fib Competitors Line Up
Industry analysts have predicted that J&J would be the first to gain AF approval by mid-2009. But other major device players are not far behind. To expand in the AF field, Medtronic is set to close on its acquisition of the Canadian firm CryoCath by the end of the year, while Boston Scientific acquired San Diego-based CryoCor in May. Both of the purchased firms have completed enrollment in AF pivotal trials using cryoablation catheters (8"The Gray Sheet" Sept. 29, 2008, p. 17).
St. Jude Medical, CardioFocus and AtriCure are among other companies seeking an AF ablation indication for catheter or surgical systems.
Generally, Biosense Webster, which is J&J's electrophysiology business, is a growth driver for the company's struggling Cordis cardiac device unit. Although Cordis sales as a whole were down 10% in the third quarter from a year ago, the Biosense Webster segment saw double-digit growth in the period, according to results reported last week.
- David Filmore
Sign up for your 30-day, risk-free trial of "The Gray Sheet" today.
"The Gray Sheet" gives you 51 issues per year filled with useful articles that will help you meet your business and regulatory objectives
Comments