Article preview from "The Gray Sheet"- May 17, 2010
St. Jude Medical has removed Epicor LP cardiac ablation system marketing materials from its website to address a recent FDA warning letter alleging off-label promotion of the device to treat atrial fibrillation.
Article preview from "The Gray Sheet"- May 17, 2010
St. Jude Medical has removed Epicor LP cardiac ablation system marketing materials from its website to address a recent FDA warning letter alleging off-label promotion of the device to treat atrial fibrillation.
While the device is 510(k) cleared for "ablation of cardiac tissue during cardiac surgery," St. Jude's website described how the system could create "box" lesions and "Maze" lesions, the April 23 warning letter states.
Such lesions are intended to treat atrial fibrillation, according to the agency. Therefore, FDA considers these claims on the firm's website to be promotion for AF treatment.
The warning letter similarly faults other Epicor promotional materials on AF treatment, such as PowerPoint slides for sales reps. The letter stemmed from a July 29, 2009, inspection of St. Jude's Sunnyvale, Calif., facilities and a review of the firm's website.
An AF indication for Epicor LP is being evaluated under an investigational device exemption, but has not yet been approved for marketing, FDA notes.
"The company is working diligently to address the points raised in the warning letter and to resolve FDA's concerns," the company states in a May 4 filing with the Securities and Exchange Commission.
The firm's response was due May 14, according to FDA.
St. Jude notes that the letter "is not expected to have any material impact on the company's business."
FDA Has A Good Point, Heart Rhythm Expert Says
Heart rhythm expert Douglas Zipes, M.D., a former president of the American College of Cardiology, said in a May 13 interview that while box lesions and Maze lesions could be considered generic terms and could conceivably be used to treat some ventricular arrhythmias, he would basically "agree with FDA that those terms and those procedures are for atrial fibrillation."
"You could create a box lesion, I guess, for anything, but Maze is really atrial fib," and any electrophysiologist hearing the term would make that connection, Zipes said.
The St. Jude warning letter suggests that FDA is interpreting clearances of 510(k) devices very narrowly in the current climate of intense congressional, Institute of Medicine and FDA scrutiny of the 510(k) process, according to attorney Arnold I. Friede (Arnold I. Friede & Associates).
Thus, FDA will likely find off-label promotion in cases that could conceivably be interpreted as off-label promotion, whether it is direct or implied, as in St. Jude's case, Friede suggested in a May 13 interview.
FDA "wants to send a strong message to industry that times have changed and [that they're] looking harder at this," Friede speculated. "They want to send that message not only to industry, but to Congress and the people that have been critical of their oversight in this area."
"I think what FDA seems to be saying is, 'We're going to be taking a narrow view of what you're cleared to say, and therefore, be careful,'" he added.
DOJ Also Looking Into Off-Label Promotion
St. Jude Medical is among several firms that previously have been targeted by an ongoing Justice Department investigation into off-label promotion of cardiac ablation devices for atrial fibrillation - including the Epicor device.
Other ablation device makers targeted in the DoJ investigation include Medtronic and Boston Scientific. Two additional firms - AtriCure and Endoscopic Technologies - have already announced settlements with the government without admitting any wrongdoing.
- Ingrid Mezo
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