Comprehensive Compliance Program at Cardiovascular Systems Inc.
Cardiovascular Systems (“CSI” or “[the] Company”) is a publicly traded medical device company that develops, manufactures, and markets atherectomy devices to treat vascular and coronary diseases. As a medical device manufacturer, CSI recognizes the importance of adhering to applicable standards and laws. Ethical business practices provide a critical foundation for success and also protects CSI’s reputation and mission in the industry and community. CSI is committed to the continuous development and improvement of its Comprehensive Compliance Program (“Compliance Program”) pursuant to California Health and Safety Code, Division 104, Part 15, Chapter 8, Sections 119400-119402 (“California Law”). Under the U.S. Department of Health and Human Services’ “OIG Compliance Program Guidance for Pharmaceutical Manufacturers,” the OIG also applies the compliance program elements and potential risk areas to manufacturers in the medical device industry.
CSI’s Compliance Program applies to all employees, officers, directors, and contractors (“Representatives”) at CSI. All Representatives of CSI are expected to uphold CSI’s Code of Ethics and Business Conduct (“Code”). Each Representative has an obligation to behave according to ethical standards that comply with the Code, CSI’s policies, and the letter and spirit of applicable laws, rules and regulations. Violations of the Code may lead to serious sanctions including discipline up to and including immediate termination, at the sole discretion of the Company. The Company may, in addition, seek civil recourse against Representative and/or refer alleged criminal misconduct to law enforcement agencies. CSI Representatives are also expected to review company policies and complete online and in-person Compliance training on an annual basis. CSI maintains an open-door policy and an anonymous telephone hotline or email for Representatives to raise concerns and to encourage the reporting of suspected violations of law or the Code without fear of retribution or retaliation. Reports of a known or suspected violation will be promptly and thoroughly investigated. If a violation has occurred, CSI will take appropriate actions to prevent similar future violations. Such actions may also include an assessment of current policies and/or procedures in place and a continuous improvement to current design or practices.
CSI hereby declares to the best of its knowledge that its Compliance Program meets the expectations set under California Law. CSI is aware that internal and external variables (i.e. company size, emerging areas of risk, etc.) may affect immediate and/or long-term compliance needs. Thus, CSI will continue its efforts toward the improvement of its Compliance Program to promptly and reasonably address those compliance needs.
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