Advanced Neuromodulation Systems Provides Update of Its Discussions With the FDA Regarding the Approval Process for Its IPG.Business Editors/Health & Medical Writers DALLAS--(BUSINESS WIRE)--April 4, 2001 Advanced Neuromodulation Systems Inc. (ANS (ANS Communications, Inc, Purchase, NY) An ISP, Internet backbone and provider of private data network services, founded in 1990 as Advanced Network & Services, Inc., by IBM, MCI and Merit (consortium of Michigan universities). ) (Nasdaq:ANSI (American National Standards Institute, New York, www.ansi.org) A membership organization founded in 1918 that coordinates the development of U.S. voluntary national standards in both the private and public sectors. It is the U.S. member body to ISO and IEC. ) today announced that ANS and the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. have agreed on an approach to accelerate submission and review of a premarket approval premarket approval Medical devices A scientific and regulatory review by the FDA to ensure the safety and effectiveness of a Class III device, before its approval for marketing. See Advisory panel, Medical device. (PMA PMA (papillary-marginal-attached), n a system of epidemiologic scoring of periodontal disease devised by Schour and Massler in which the symbols denote the areas involved in gingival inflammation. PMA Progressive muscular atrophy ) application for ANS' Totally Implanted Pulse Generator Pulse generator An electronic circuit capable of producing a waveform that rises abruptly, maintains a relatively flat top for an extremely short interval, and then rapidly falls to zero. (IPG IPG Implantable pulse generator, see there ) Spinal Cord spinal cord, the part of the nervous system occupying the hollow interior (vertebral canal) of the series of vertebrae that form the spinal column, technically known as the vertebral column. Stimulation for relief of chronic pain of the trunk and/or limbs. Chris Chavez, president and chief executive officer of ANS, said: "ANS and the FDA have cooperated to identify and meet PMA requirements which ANS believes can result in approval on an accelerated basis. Although we were disappointed to learn of the FDA denial of our petition for reclassification Reclassification The process of changing the class of mutual funds once certain requirements have been met. These requirements are generally placed on load mutual funds. Reclassification is not considered to be a taxable event. , we were encouraged by advice offered by FDA representatives to address their broader reclassification concerns through the PMA review process. "After the reclassification denial, ANS promptly engaged in dialogue and correspondence with the FDA to discuss PMA requirements. To our great delight, the FDA has been responsive within time periods established by agreement, and our continuing dialogue has been positively constructive. As a result of our continuing experience, we are confident that as we do our part, the FDA will do its part to confirm our desire to make the ANS IPG available to U.S. practitioners within the time period required by law." In a written response to ANS dated March 27, 2001, the FDA said, "We believe that the approach that you have proposed to demonstrate the safety and effectiveness of your implantable IPG is a reasonable one." Consistent with this acceptance of its approach, ANS has commenced the formal submission of a PMA application. ANS will submit its comprehensive PMA application later this month. Upon submission, by law, the FDA will have up to 180 days to review and respond to the PMA filing. Chavez stated further, "We are confident based on our experience with the FDA during the last four weeks that the direction provided by Dr. Bernard Statland, director of the FDA Office of Device Evaluation, will result in a timely and mutually beneficial outcome." On a parallel track, Chavez said that ANS has submitted an official letter to the FDA in response to the FDA's Feb. 23, 2001, reclassification petition denial letter as a prelude to ANS' continuing effort to appeal the denial of its reclassification petition. About Advanced Neuromodulation Systems Advanced Neuromodulation Systems designs, develops, manufactures and markets implantable systems used to manage chronic intractable pain and other disorders of the central nervous system. Additional information is available at www.ansmedical.com. "Safe harbor" statement under the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995: Statements contained in this document that are not based on historical facts are "forward-looking statements." Terms such as "plan," "should," "would," "anticipate," "believe," "intend," "estimate," "expect," "predict," "scheduled," "new market," "potential market applications" and similar expressions are intended to identify forward-looking statements. Such statements are by nature subject to uncertainties and risks, including but not limited to: completion of research and development projects in an efficient and timely manner; obtaining regulatory approvals on a timely and cost-efficient basis to permit the introduction of new products; the satisfactory completion of clinical trials and/or market tests prior to the introduction of new products; the adequacy, acceptability and timeliness of component supply; the approval of new products by reimbursement agencies like insurance companies, HMOs, Medicare and Medicaid Medicare and Medicaid U.S. government programs in effect since 1966. Medicare covers most people 65 or older and those with long-term disabilities. Part A, a hospital insurance plan, also pays for home health visits and hospice care. ; the efficacy of the company's products for new applications; and other risks detailed from time to time in the company's SEC filings. Consequently, if such management assumptions prove to be incorrect or such risks or uncertainties materialize, anticipated results could differ materially from those forecast in forward-looking statements. |
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