A Medical Device Daily

Cyberonics (Houston) reported that it received a warning letter, its second in three years, from the Dallas District Office of the FDA regarding what it said were nonconformities with current good manufacturing practice (CGMP) requirements of the quality system regulation for medical devices.

The letter, dated Dec. 22, followed an inspection of Cyberonics' Houston manufacturing operations that occurred from July 20 through Sept. 15, 2004, the issuance of a number of Form-483 inspectional observations, Cyberonics' submission of written responses dated Sept. 17, Oct. 7 and Dec. 8, 2004, and a meeting with the Dallas District Office on Nov. 9.

The warning letter states that the company's responses are incomplete and do not satisfactorily address the specific Form-483 observations and issues identified in the letter. The warning letter is posted on the FDA's web site and the company has until Jan. 19 to respond.

According to Skip Cummins, Cyberonics' chairman and CEO, while the company is “disappointed“ by the warning letter, production of its sole product, the VNS Therapy System, will continue without interruption at the plant. He added that the company also received a warning letter from the FDA after the last inspection of its facilities in January 2001.

“Today, just as it was in 2001, Cyberonics is firmly committed not only to the design and manufacture of high quality products that satisfy our customers' needs, but also to compliance with all regulations,“ Cummins said in a statement. “To that end, we will work diligently with FDA, just as we did in 2001, to submit a complete response that satisfactorily addresses the issues raised in the warning letter, in this case by Jan. 19, 2005, as requested.“

Cummins also said that his company will continue to work with the FDA's Center for Devices and Radiological Health to obtain that agency's decision regarding the approvability of the company's treatment-resistant depression expedited review PMA-S by Jan. 31.

Cyberonics' VNS Therapy is a device surgically implanted in a patient that delivers mild electrical shocks to a nerve in the brain as a treatment for epileptic seizures. An FDA advisory committee supported the company's application in June to use VNS Therapy as a treatment for depression. But the FDA, in a rare move, overruled the panel and rejected the application in August (Medical Device Daily, Aug. 13, 2004).

Since the turndown, Cyberonics has been pursuing an informal appeal to get the FDA to reconsider. If that approach fails to work, Cyberonics said it would file a formal appeal. If the appeals are unsuccessful, the company must decide if it wants to conduct more clinical trials to aid its application for treating depression.

The VNS Therapy System was approved by the FDA in July 1997 for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents over 12 years of age with partial onset seizures that are refractory to antiepileptic medications. The system also is approved for sale as a treatment for epilepsy in all the member countries of the European Economic Area, Canada, Australia and other markets.

The system is approved for sale in the European Economic Area and in Canada as a treatment for depression in patients with treatment-resistant or treatment-intolerant major depressive episodes, including unipolar depression and bipolar disorder.

ACT launches engineering group

Advanced Cooling Technologies (ACT; Lancaster, Pennsylvania) has reported launch of its Engineering Services Group, providing thermal engineering services to medical equipment, electronics and energy systems markets. The scope of services includes heat pipe design, prototyping, testing and consulting. Scott Garner, vice president of engineering services and products at ACT, will head this group. Garner is a co-founder of ACT.

“ACT's entry to the thermal engineering service business is a timely response to the market demand,“ said Jon Zuo, president and chief technical officer of ACT.

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