News
Pulsar Vascular Brain-Aneurysm Device Nears Market Approval In Europe
By Brian Gormley
29 March 2012
Pulsar Vascular Inc., a start-up launched by Sanderling Ventures, is nearing European regulatory approval for what may be the first medical device designed specifically for the most common type of brain aneurysm.
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% of the time, according to the Brain Aneurysm Foundation. Six million Americans have an un-ruptured brain aneurysm, according to the foundation.
Historically, surgeons treated un-ruptured brain aneurysms by placing a clip over the aneurysm's opening, or its neck. In the 1990s, companies such as Target Therapeutics Inc., MicroVention Inc. and Micrus Endovascular Corp. developed less-invasive, catheter-based alternatives.
In these procedures, a stent forms a bridge across the aneurysm neck. This enables the physician, an interventional neuroradiologist, to fill the aneurysm with coils. Clots then form over the coils, sealing off the aneurysm. Last decade, an analysis of data from the International Subarachnoid Aneurysm Trial showed that these "endovascular" procedures are generally better than the surgery.
The success of endovascular procedures led to returns for venture and public-market investors. Boston Scientific Corp. acquired publicly traded Target Therapeutics in 1997, Terumo Corp. bought venture-backed MicroVention in 2006, and Johnson & Johnson snapped up Micrus Endovascular, which went public in 2005, in 2010.
Recently, Sequent Medical Inc., whose founders include entrepreneurs who launched MicroVention, raised a $26 million Series C round, led by Delphi Ventures, a MicroVention investor. Sequent's system is designed to improve upon the coil technique.
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, according to Robert Abrams, a Sanderling operating partner and chief executive of Pulsar Vascular. About 65% of brain aneurysms occur at or near bifurcation, he said.
Physicians' options include deploying multiple stents, but complications are more common in these situations than they are when there is no bifurcation, according to Abrams. Pulsar aims to lower complication rates by enabling interventional neuroradiologists to use a single device. With the company's PulseRider system, invented in-house, physicians can 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 inherent design is versatile enough so that, with a few variations of shape and size, we can cover the multitude of anatomical variations," Abrams said. "We call it shape-appropriate reconstruction."
The San Jose-based company has designed the system to be "re-sheathable," which means the physician can withdraw it and then re-deploy it if he doesn't like the way it was positioned originally. This should improve safety and ease of use, according to Abrams, who was director of new business development for Target Therapeutics when it merged with Boston Scientific. Sanderling Managing Director Timothy Mills, Target's former chief scientific officer and corporate vice president of new business development, is Pulsar's chairman.
Pulsar has performed initial human clinical studies outside the U.S. and expects to earn marketing approval in Europe by year-end, said Abrams. Sanderling has funded the company with a undisclosed amount of Series A financing that has come in through multiple tranches. Pulsar now aims to raise up to $15 million in Series B financing to support European marketing clearance and a limited U.S. introduction through a Humanitarian Device Exemption. Pulsar also would use the round to prepare for clinical testing that would support wider use through a Premarket Approval, Abrams said.