Advanced Neuromodulation Systems Receives CE Mark Approval for Its Totally Implantable Pulse Generator; Initial Patient Implants Completed in Europe.Business Editors & Health/Medical Writers DALLAS--(BUSINESS WIRE)--Dec. 20, 2000 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 it has received CE Mark approval for its Genesis(TM) Totally Implantable Pulse Generator implantable pulse generator Cardiac pacing A pacemaker used for permanent pacing, which is placed inside a pocket under the skin; the leads are positioned in or on the heart (IPG IPG Implantable pulse generator, see there ) Spinal Cord Stimulator Spinal Cord Stimulator (SCS) or Dorsal Column Stimulator (DCS) is an implantable medical device used to treat chronic pain of neurologic origin. An electric impulse generated by the device near the dorsal surface of the spinal cord provides a paresthesia ("tingling") for pain relief, and that it has completed initial patient implants of its IPG in Europe. The CE Mark is the symbol used to indicate that a particular product complies with the relevant European regulatory requirements and has achieved a satisfactory level of safety, and thus may be marketed freely throughout the European Community. Chris Chavez, chief executive officer of ANS, explained that two types of implantable spinal cord stimulation (SCS) devices currently are used to treat patients with chronic pain: Radio Frequency (RF) and IPG systems. "According to the clinical literature, the major categories of chronic pain treated in Europe with both RF and IPG systems include back pain, angina, regional pain syndrome, ischemic Ischemic An inadequate supply of blood to a part of the body, caused by partial or total blockage of an artery. Mentioned in: Antiangiogenic Therapy, Subarachnoid Hemorrhage, Ventricular Fibrillation ischemic pain associated with peripheral vascular disease Peripheral Vascular Disease Definition Peripheral vascular disease is a narrowing of blood vessels that restricts blood flow. It mostly occurs in the legs, but is sometimes seen in the arms. , and unilateral limb pain," said Chavez. "RF-SCS systems are generally used to treat patients with complex chronic pain problems because RF systems can drive up to 16 electrodes with more power and substantially more programming flexibility than IPG systems. The RF market is estimated to exceed $50 million worldwide, as is growing 10-15 percent annually. ANS is the technology leader in the RF segment with a 50 percent market share," he said. The CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. continued, "IPG devices currently account for 80 percent of total SCS implants worldwide and are ideally suited for clinical applications with lower power and programming requirements. This market, which currently is dominated by Medtronic (NYSE NYSE See: New York Stock Exchange :MDT), now exceeds $150 million and is growing 30 percent annually. "CE Mark approval is an important development for ANS that positions us to begin competing in this exciting growth market, initially in Europe. Physicians that implant RF systems also implant IPG systems. Based on ANS's success in the smaller RF segment, we are confident that we will also successfully commercialize our Genesis IPG." Chavez added, "ANS has submitted constructive comments to the FDA in an effort to accelerate a final decision on the reclassification of its IPG-SCS to treat chronic pain from a Class III to a CLASS II device. The final comment review period ended on Nov. 3, 2000, and we expect the reclassification decision immediately after all comments have been reviewed." About Advanced Neuromodulation Systems Inc. Advanced Neuromodulation Systems designs, develops, manufactures and markets implantable systems used to manage chronic intractable pain and other disorders of the central nervous system. The following is a "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 successful reclassification of the IPG by the FDA; 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. |
|
||||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion