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FORMER MEDICAL COMPANY OFFICIAL SENTENCED TO 10 MONTHS

WASHINGTON, D.C. A former official of Micro Interventional Systems, Inc. (MIS), a now-defunct medical device manufacturer, was sentenced to 10 months in jail, the Justice Department announced today. Sentencing took place today in San Jose, California. On April 14, 2000, Anna Maria Carrillo, the ex-Director of Regulatory and Clinical Affairs and Quality Assurance at MIS, pleaded guilty to a one-count Information charging her with conspiracy to defraud the U.S. Food & Drug Administration (FDA).

The Sunnyvale, California-based company developed and manufactured catheters and other medical devices for coronary and neurological interventional radiology procedures. For example, MIS' catheters were used by doctors in angioplasty procedures and to repair dangerous brain aneurysms.

Ms. Carrillo was charged with conspiring to submit materially false and fraudulent documents to the FDA during the period December 1993 until approximately August 1996. Through these submissions, MIS sought to obtain the federal agency's clearance to market catheter medical devices. The documents, known as "510(k) submissions" because they are submitted pursuant to Section 510(k) of the Federal Food, Drug and Cosmetic Act, are a prerequisite to a company's marketing of certain medical devices, such as the catheters that were the subject of the Indictment.

Through the 510(k), a company seeks to demonstrate to the FDA that its device is "substantially equivalent" to a predicate device (one that is already on the market legally). A 510(k) submission typically contains documentation, including test protocols and results of testing on the actual device, reflecting the device's operating specifications and its ability to satisfy the specifications. With respect to catheters and other devices used in the body, biocompatibility testing typically is required to demonstrate that the device will not cause an adverse reaction within the body. In determining whether a new medical device is substantially equivalent to a predicate device, the FDA relies on the accuracy and truthfulness of the information provided by the manufacturer in the 510(k) submission for the new device.

As Director of Regulatory and Clinical Affairs and Quality Assurance at MIS, Ms. Carrillo prepared and submitted numerous fraudulent 510(k)s to the FDA seeking clearance for catheters and other related medical devices intended for cardiological and neurological use. The false information contained in the 510(k)s often related to biocompatibility and functional testing, which is designed to ensure that the device performs properly and without adverse effects to the patient's body.

Additionally, Ms. Carrillo falsely reported to the FDA that tests had been conducted on specific catheter medical devices; she concealed failing catheter test results from the FDA; and she concealed and covered up material facts from the FDA relative to the safety and effectiveness of catheter medical devices. The government is unaware of any patient deaths or injuries that directly resulted from the fraudulent information submitted in the subject 510(k)s.

The Indictment in this case followed an extensive investigation of MIS's 510(k) practices by the Office of Consumer Litigation of the Justice Department's Civil Division, the United States Attorney's Office for the Northern District of California, the FDA's Office of the Chief Counsel, the FDA's Office of Criminal Investigations and the FBI.

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