Micrus Corp., a privately-held medical device firm, announced today that the company has received U.S. Food and Drug Administration approval to begin clinical studies of the company's ACT MicroCoil Delivery System under an Investigational Device Exemption ("IDE"). This new medical device will be used for the minimally invasive treatment of intracranial aneurysms.
Intracranial aneurysms are saclike widenings of cranial arteries, which can form due to atherosclerosis, hypertension, trauma or other factors. Rupture of such aneurysms results in subarachnoid hemorrhage and, if untreated, can lead to stroke and death. While surgery has been a common form of treatment, less invasive procedures are now being performed to decrease risk to the patient, and reduce the procedure time and ultimate cost of the treatment. The Micrus ACT MicroCoil Delivery System is one such non-surgical method of treating intracranial aneurysms. The company believes the ACT MicroCoil Delivery System is superior to other minimally invasive treatment devices, including first-generation coil systems.
The Micrus ACT MicroCoils are designed to be released into the aneurysm to isolate it from arterial flow, thereby decreasing the potential for rupture or re-rupture. The ACT MicroCoil Delivery System was designed, developed and patented by Micrus Corp. Aspects of the system were jointly developed with Lawrence Livermore National Laboratories under a licensing agreement between the two parties.
Micrus expects to begin enrolling study patients at sites within the U.S. and Europe within the next three months. The company believes the worldwide market potential for the ACT MicroCoil Delivery System to be in excess of $100 million annually.