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FDA says VNS device lacks data

Posted by jrbecker on June 14, 2004, at 15:46:02

official meeting of the FDA panel on VNS meets tomorrow (6/17)/....


BX UPDATE 1-US FDA staff says Cyberonics` device lacks data

June 14, 2004 13:39:23 (ET)


http://biz.yahoo.com/prnews/040614/dem011_1.html

WASHINGTON, June 14 (Reuters) - Cyberonics' (CYBX,Trade) VNS Therapy lacks enough data to show it is safe and effective for use in chronically depressed patients, U.S. Food and Drug Administration staff reviewers said in a preliminary report released on Monday.

"FDA has identified several concerns regarding whether the clinical data ... provides reasonable assurance that VNS is effective," the reviewers said in a report posted on the agency Web site.

Shares of Houston, Texas-based Cyberonics were up $1.06, or 5.76 percent, to $19.48 in afternoon trade on Nasdaq after soaring about 20 percent immediately after the report.

On Tuesday, Cyberonics faces a FDA panel of outside experts who will discuss whether to recommend the company's pacemaker-like device, called VNS Therapy, for depression.

Approval of the new use for the device is key to the company's growth prospects, analysts say.

Despite the concerns, A.G. Edwards analysts Jan Wald said the reviewers' simply stated questions were "viewed as positive."

But "the questions are so fundamental that they might belie how complicated a task Cyberonics has in convincing the panel that they do have a trial that can withstand scrutiny," Wald added.

In their report, the FDA reviewers said a "lack of systematically collected safety data" in one study also made it difficult to determine "whether the clinical data ... provide reasonable assurance that the device is safe."

VNS Therapy, which is surgically implanted to deliver electrical pulses to the brain, is already cleared for epilepsy.

(Additional reporting by Bill Berkrot in New York)


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