FDA has granted Rapid Medical De Novo clearance to market its temporary coil embolization assist device for use in the treatment of aneurysms.
The device, called Comaneci, is designed to temporarily bridge the neck of an aneurysm during coil embolization, giving physicians a way to treat challenging cases without the use of stents or balloon remodeling.
The technology is CE-marked and has been used in about 3,000 procedures outside the U.S., according to the Yokneam, Israel-based company.
Patients with wide-necked aneurysms, particularly ruptured cerebral aneurysms, pose challenges to physicians. Although simpler cases can be treated with standard coiling, physicians must use adjunctive devices to address these more complex aneurysms.
Physicians have explored the use of stents in this context but the implants are associated with a risk of complications stemming from hemorrhages. That risk has led many physicians to opt for balloon remodeling but this comes with its own complications, notably the potential for patients to suffer injuries related to restricted blood flow.
Rapid Medical developed Comaneci to provide physicians with an alternative to these two methods. The device is designed to temporarily bridge the neck of an aneurysm during coil embolization, thereby supporting coil occlusion without affecting the blood flow in the artery.
“It should be a valuable alternative for ruptured and unruptured wide neck aneurysms, typically requiring balloon assistance for coil embolization, since it provides temporary protection of the parent artery during aneurysm coiling without arresting flow," Peter Kim Nelson, a professor at the New York University School of Medicine, said in a statement.
Physicians have published the results of some of the procedures completed outside of the U.S., linking the device to a 78% success rate. That study of 18 cases reported one clinically-relevant complication.
FDA’s clearance of the device comes weeks after Rapid Medical raised $20 million. The company said it will use the money to build out its U.S. commercial infrastructure.