NMT MEDICAL VOLUNTARILY WITHDRAWS CARDIOSEAL PFO HDE.
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) 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(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 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(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 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.
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|Publication:||Biotech Equipment Update|
|Date:||Oct 1, 2006|
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