Healthcare Industry News: Patent Foramen Ovale
News Release - August 16, 2006
NMT Medical Voluntarily Withdraws CardioSEAL(R) PFO HDE and Receives FDA Approval for New STARFlex(R) PFO IDE StudyBOSTON, Aug. 16 (HSMN NewsFeed) -- NMT Medical, Inc. (Nasdaq: NMTI ), 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sources of migraine headaches, stroke and other potential brain attacks, announced today that it has voluntarily withdrawn the Humanitarian Device Exemption (HDE) granted by the U.S. Food and Drug Administration (FDA) on February 1, 2000 for its CardioSEAL® Septal Repair System for closure of Patent Foramen Ovale (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® will continue to be commercially available in the United States under the pre-market approval (PMA) indication for ventricular septal defects (VSD).
In conjunction with this decision, the Company also received FDA approval for a new PFO/stroke Investigational Device Exemption (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® implant technology. Patients previously covered by the HDE only had access to the Company's original CardioSEAL® 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 Chief Executive Officer 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 attack (TIA) 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® 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 interventional cardiologist with a broad range of cardiac septal repair implants delivered with nonsurgical catheter techniques. For more information about NMT Medical, please visit http://www.nmtmedical.com.
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements -- including statements regarding the CARS IDE and CLOSURE I study, the impact of the voluntary withdrawal of the Company's HDE on the Company's product revenue, the Company's financial and sales expectations, expansion of the Company's products in the United States and abroad, and expected commercial approvals -- involve known and unknown risks, uncertainties or other factors that may cause actual results, performance or achievements of the Company to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Factors that may cause such a difference include, but are not limited to, the Company's ability to develop and commercialize new products, a potential delay in the regulatory process with the U.S. Food and Drug Administration and foreign regulatory agencies, as well as risk factors discussed under the heading "Risk Factors" included in the Company's Annual Report on Form 10-K for the year ended December 31, 2005, Quarterly Report on Form 10-Q for the quarter ended June 30, 2006 and subsequent filings with the U.S. Securities and Exchange Commission.
Source: NMT Medical
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