NMT MEDICAL VOLUNTARILY WITHDRAWS CARDIOSEAL PFO HDE.NMT (Nordic Mobile Telephone) An analog cellular phone system deployed in more than 40 countries in Europe. Launched in the Scandinavian countries in 1979, NMT was the first analog cellphone system. Both 450 MHz and 900 MHz versions are available. See cellular generations. Medical, Inc. (NASDAQ NASDAQ
in full National Association of Securities Dealers Automated Quotations
U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :NMTI NMTI Northwest Medical Teams International (Tigard, OR, USA)
NMTI Node Management Terminal Interface , Boston, Mass. an advanced medical technology company that designs, develops, manufactures and markets proprietary implant technologies that allow interventional cardiologists to treat cardiac sources of migraine headaches, stroke and other potential brain attacks, has voluntarily withdrawn the Humanitarian Device Exemption (HDE) granted by the U.S. Food and Drug Administration (FDA FDA
Food and Drug Administration
n.pr See Food and Drug Administration.
n.pr the abbreviation for the Food and Drug Administration. ) on February 1, 2000 for its CardioSEAL(R) Septal septal /sep·tal/ (sep´tal) pertaining to a septum.
Of or relating to a septum or septa. Repair System for closure of patent foramen ovale patent foramen ovale PFO Cardiology An opening between the left and right atria which allows blood to bypass the lungs in utero; the FO normally closes shortly after birth, but remains open in up to 20%; a PFO is, in absence of other cardiac defects, is of no consequence (PFO) in patients with recurrent stroke. The withdrawal is effective October 31, 2006.
NMT was recently contacted by the FDA to review its existing HDE, which was approved more than six years ago. Since the HDE was approved, clinical conditions have significantly changed and the subset of patients who once qualified for consideration for PFO closure has increased beyond 4,000, the limit normally allowed under the HDE indication. The withdrawal does not reflect a device safety issue. CardioSEAL(R) will continue to be commercially available in the United States under the pre-market approval (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 ) indication for ventricular septal defects (VSD VSD
ventricular septal defect
ventricular septal defect.
VSD Ventricular septal defect, see there; also virtually safe dose ).
In conjunction with this decision, the company also received FDA approval for a new PFO/stroke Investigational Device Exemption An Investigational Device Exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to Food and (IDE), called CARS (Closure After Recurrent Stroke). The CARS IDE will supplement the company's ongoing CLOSURE I clinical trial to evaluate the connection between PFO and stroke. The company will provide eligible patients of both CARS and CLOSURE I with NMT's newer STARFlex(R) implant technology. Patients previously covered by the HDE only had access to the company's original CardioSEAL(R) device. The CARS IDE will provide continued PFO closure access to certain patients who previously were eligible for treatment under the HDE. However, while patients in the CLOSURE I trial receive the implant at no cost, those covered under the CARS IDE can be charged for the device.
Commenting on the FDA actions, John E. Ahern, president and 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. of NMT stated, "The FDA recently informed us that they commenced a formal HDE review process for all existing PFO closure devices. Because of the many clinical advances since its approval over six years ago, we were asked to consider voluntary withdrawal of our HDE. We expressed concern to the FDA that the company didn't want to put patients who were currently covered under the HDE at risk of losing access to PFO closure. The agency endorsed our support for those patients and as a result, quickly approved the CARS IDE. Approval of the CARS IDE, combined with our ongoing CLOSURE I trial, allows the company to maintain two sources for PFO closure in the United States."
"We remain focused on our stroke/transient 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 attack (TIA (1) (Telecommunications Industry Association, Arlington, VA, www.tiaonline.org) A membership organization founded in 1988 that sets telecommunications standards worldwide. It was originally an EIA working group that was spun off and merged with the U.S. ) objective to complete CLOSURE I and become the first company to gain PMA for these indications -- a potential market of 250,000 U.S. patients annually," added Ahern. "In addition, we continue to work with our investigators, the clinical community and the FDA to make changes to the CLOSURE I study design in order to accelerate patient enrollment. We anticipate a shift of some recurrent stroke patients with PFOs to the CARS IDE from the original HDE since patients will have access to the new STARFlex(R) technology. At this time it is difficult to determine the impact on product revenue in the U.S. as a result of the transition from paid-for HDE devices to the paid-for devices under CARS. We believe the CARS IDE is a significant competitive achievement for NMT and is necessary to accommodate the growing demand for more advanced PFO/stroke treatments."
About NMT Medical, Inc.
NMT Medical is an advanced medical technology company that designs, develops manufactures and markets proprietary implant technologies that allow interventional cardiologists to treat cardiac sources of migraine headaches, stroke and other potential brain attacks through minimally invasive, catheter-based procedures. NMT Medical is investigating the potential connection between a common cardiac defect called a PFO and brain attacks such as migraine headaches, stroke and TIAs. A PFO can allow venous blood, unfiltered and unmanaged by the lungs, to enter the arterial circulation of the brain, possibly triggering a cerebral event or brain attack. More than 21,000 PFOs have been closed globally with NMT's minimally invasive, catheter-based implant technology.
The prevalence of migraines in the United States is about 10%. Of the 28 million migraine sufferers in America, those who experience aura and have a PFO may represent a three million patient subset. Stroke is the third leading cause of death in the United States and the leading cause of disability in adults. Each year, 750,000 Americans suffer a new or recurrent stroke and 500,000 Americans experience a TIA.
The company also serves the pediatric pediatric /pe·di·at·ric/ (pe?de-at´rik) pertaining to the health of children.
Of or relating to pediatrics. interventional cardiologist with a broad range of cardiac septal repair implants delivered with nonsurgical catheter techniques.
For more information, visit http://www.nmtmedical.com or call 617/737-0930.