A Medical Device Daily

Cyberonics (Houston) on Friday said that it submitted its response to a recent FDA warning letter regarding non-conformance with Current Good Manufacturing Practice (CGMP) requirements of the Quality System Regulation for medical devices (Medical Device Daily, Jan. 5, 2005), at a recent meeting with the Dallas District Office.

The letter followed an inspection of Cyberonics' Houston manufacturing operations from July 12-Sept. 15, 2004, the issuance of a number of inspectional observations, Cyberonics' submission of written responses dated Sept. 17, Oct. 7 and Dec. 8, 2004, and a meeting with the agency's Dallas District Office on Nov. 9, 2004. The warning stated that Cyberonics' initial responses were incomplete and did not satisfactorily address the observations and issues cited in the letter.

Skip Cummins, company chairman and CEO, said that the recent “detailed and comprehensive“ response “confirmed that the longevity and survivability of Cyberonics' products conforms to the labeling and that Cyberonics' product design, validation and verification testing, complaint handling and MDR reporting procedures comply with FDA regulations and industry standards.“

He said that the response identified both corrective actions already taken and those the company “will implement in the coming months.“

Cummins added: “Cyberonics continues to manufacture and sell the VNS Therapy System to improve the lives of people touched by epilepsy in the U.S. and the lives of people touched by epilepsy and depression in Europe and Canada. We are also working diligently with FDA's Center for Devices and Radiological Health (CDRH) to obtain CDRH's decision regarding the approvability of our treatment-resistant depression Expedited Review PMA-S by Jan. 31, 2005.“

Pamela Westbrook, vice president, finance and administration and CFO for the company, also said that Cyberonics will be in a “quiet period“ until it receives a notice concerning “depression approvability“ from CDRH.

“Cyberonics' PMA Supplement Amendment was submitted in late-September 2004,“ she said, with a decision possibly coming “any time from the 120-day average FDA PMA-review period that ends this month, through the expiration of the 180-day statutory review period in late March.“ She said the only exceptions to the quiet period will be “required communications,“ such as the third-quarter earnings release set for Feb. 9.

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

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