GAITHERSBURG, Md. -- An FDA advisory panel has unanimously recommended approval of the investigational Pipeline Embolization Device to wall off large intracranial aneurysms in patients who are unlikely to respond to currently available treatments.
The Neurological Devices Panel voted 9-0 that the benefits of the device -- made by Menlo Park, Calif.-based Chestnut Medical Technologies -- outweigh its risks. The company is seeking an indication for the Pipeline Embolization Device for the endovascular treatment of large or giant wide-necked intracranial aneurysms in the cavernous and paraclinoid regions of the internal carotid artery.
In the company's trial, the device was 74% effective at achieving complete aneurysm occlusion.
If the FDA follows the advice of its advisory panel and approves the Pipeline device, it would offer patients with very large, hard-to-treat aneurysms a way to rid themselves of symptoms such as severe headaches and vision disturbances, and greatly lessen the risk of aneurysm rupture.
About half of all people who experience an intracranial aneurysm rupture will die. Among those who live, one-third will be permanently disabled, according to information from Chestnut Medical Technologies.
The FDA does not have to follow the advice of its advisory panels, but it often does, particularly in cases where panels are unanimously supportive of the medical device.
Approval would be a very big deal, Peter Nelson, MD, chief of interventional radiology at New York University, told 鶹ý following Friday's meeting.
"This is a transforming event in cerebrovascular surgery," said Nelson, who has implanted the device in about 75 patients in the U.S.
Large aneurysms, which measure between 10 mm and 25 mm, and giant aneurysms, which are greater than 25 mm in size, are rare, with about 2,000 reported cases each year. There is a greater risk of rupture with giant aneurysms, and they are much more difficult to treat.
Smaller, uniformly shaped aneurysms with small necks attaching them to the artery can be treated by surgically clipping the base of the aneurysm, or by pushing platinum coils into the aneurysms to initiate a clotting reaction. But clipping the base of an large aneurysm is very difficult and extremely risky, and often coils won't fit into an oddly-shaped aneurysm, explained Nelson.
The flexible Pipeline, which resembles a mesh tube, is inserted into the artery from which the aneurysm has developed. It works by cutting off the blood supply to the aneurysm, which, over time, eliminates the aneurysm altogether.
The panel based its endorsement on company's multicenter, single-arm study that enrolled 104 patients with a total of 106 large or giant aneurysms who underwent a procedure with the Pipeline device. The device was effective in complete aneurysm occlusion without major parent vessel stenosis in 78 of 106 (74%) of the cases.
The committee voted 9-0 that the device is effective.
The study's primary safety endpoint of ipsilateral stroke and neurologic death was met. In total, 5.6% of cases met the predefined safety endpoint of serious safety events after surgery, including stroke, hemorrhage, and "possible neurologic death."
The panel also voted 9-0 that the Pipeline device is safe.
The panel heard stories from eight patients who received the device as part of the trial. All of them were stricken with debilitating headaches, sought medical treatment, and eventually learned through MRI that they had massive aneurysms.
All of the patients said the Pipeline device saved their lives, and urged FDA approval.