Pulsar Vascular Gets CE Mark for Cerebral Aneurysm Treatment Device

San Jose, Calif.-based Pulsar Vascular, a held developer of neurovascular technology, received European CE mark approval for its lead product, the PulseRider. Pulsar Vascular is a start-up launched by San Mateo, Calif.-based biomedical investment firm Sanderling Ventures.

The PulseRider implant is used to bridge the neck of cerebral aneurysms previously not receptive to endovascular therapy. The device is implanted via standard, minimally invasive, endovascular techniques, which provides an alternative treatment option to open surgery.

With CE mark in hand, the company plans a full European launch.

Brain aneurysms occur when an artery weakens and bulges out like a balloon. If it ruptures it will cause bleeding in the brain. Ruptured aneurysms, which occur in 30,000 Americans each year, are fatal 40 percent of the time, according to the Brain Aneurysm Foundation. As estimated 6 million Americans have an un-ruptured brain aneurysm, according to the foundation.

Surgeons traditionally treated un-ruptured brain aneurysms by placing a clip over the aneurysm’s opening (its neck). In the 1990s, a number of companys developed less-invasive, catheter-based alternatives. In these procedures, a stent forms a bridge across the aneurysm neck, which allows interventional neuroradiologists to fill the aneurysm with coils. Clots then form over the coils, sealing off the aneurysm.

“This achievement signifies validation of our scientifically advanced platform technology, which has received an enthusiastic reception from physicians both in the U.S. and Europe,” said Rob Abrams, CEO of Pulsar Vascular (and a partner at Sanderling), calling it a “major milestone” for the company. “We look forward to making this pioneering technology available to European clinicians this year and beginning a small U.S. clinical study early in 2014 to provide further clinical evidence of the utility of our product.”  

Though they work well in simple cases, current treatment devices aren’t optimal when the aneurysm occurs at the junction of a main artery and a side branch—called a bifurcated artery. According to Abrams, about 65 percent of brain aneurysms occur at or near bifurcation.

Physicians’ options currently include deploying multiple stents, but complications are more common in these situations than they are when there is no bifurcation, according to the company. Pulsar’s system attempts to lower complication rates by enabling interventional neuroradiologists to use only one device. According to the company, the PulseRider system gives physicians the ability to stent both the right and left branch of the bifurcated vessel. The device is soft and flexible enough to be deployed across many types of anatomies seen in patients with bifurcated aneurysms. The system is designed to be “re-sheathable,” which means the physician can withdraw it and then re-deploy it if he or she doesn’t like the way it originally was positioned.

The U.S. clinical study will be a humanitarian device exemption tria done under an investigational device exemption granted by the U.S. Food and Drug Administration. It will be a multi-center clinical trial to support the U.S. Food and Drug Administration approval of the PulseRider.