Endovascular Implant Bridges Cerebral Aneurysms

A novel implant bridges the neck of cerebral aneurysms previously considered unsuitable for endovascular therapy, providing an alternative option to open surgery.

The PulseRider implant leverages classic arch design to treat aneurysms in conjunction with embolic coils and/or flow diversion. Using the device, physicians can stent both the right and left branches of the bifurcated vessel. The device is also soft and flexible enough to be deployed across many types of bifurcated aneurysm anatomies. Once in place, the interventional neuroradiologist can fill the aneurysm with coils. Blood clots then form over the coils, sealing off the aneurysm.

The system is implanted in a minimally invasive procedure and is also designed to be re-sheathable, allowing the physician to withdraw and then re-deploy the implant to the closest position originally selected. The PulseRider implant is a product of Pulsar Vascular (San Jose, CA, USA), and has received the European Community CE marking of approval. The US clinical study is intended to be a humanitarian device exemption done under a US Food and Drug administration (FDA) investigational device exemption (IDE).

“Existing brain-aneurysm treatments work well in relatively simple cases, but aren't optimal when the aneurysm occurs in a bifurcated artery, or the junction of a main artery and a side branch; about 65% of brain aneurysms occur at or near bifurcation,” said Rob Abrams, CEO of Pulsar Vascular. “The inherent design is versatile enough so that, with a few variations of shape and size, we can cover the multitude of anatomical variations. We call it shape-appropriate reconstruction.”

An intracranial brain aneurysm is a cerebrovascular disorder in which weakness in the wall of a cerebral artery or vein causes a localized dilation or ballooning of the blood vessel. If the aneurysm ruptures, blood leaks into the calvarium, resulting in a subarachnoid hemorrhage. Onset is usually sudden and classically presents as a thunderclap headache far worse than previous headaches.

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