Earlier this month, NMT Medical, Inc. (Nasdaq: NMTI) has voluntarily withdrawn the humanitarian Device Exemption (HDE) granted by the USFDA on February 1, 2000 for its CardioSEAL® Septal Repair System for closure of patent foramen ovale (PFO) in patients with recurrent stroke.

NMT Medical, Inc 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.

The said withdrawal, which will be effective October 31, 2006, does not reflect a device safety issue and CardioSEAL® will continue to be commercially available in the United States under the pre-market approval (PMA) indication for ventricular septal defects (VSD).

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.

In conjunction of the company's decision to withdraw its HDE for CardioSEAL® Septal Repair System, it has also received USFDA 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.

Find more details at the press release.