Stryker Corp. has launched its Surpass Evolve flow diverter following an earlier U.S. FDA approval. According to the company, it is the first 64-wire cobalt chromium flow diverter in the U.S. designed to redirect blood flow and promote aneurysm healing.
An aneurysm occurs when part of a blood vessel becomes weak, causing it to bulge and fill with blood. While aneurysms can occur in any blood vessel in the body, those that occur in the brain are the most life-threatening. About 500,000 deaths occur each year as a result of a brain aneurysm, the company said, citing statistics from the Brain Aneurysm Foundation website.
Ajay Wakhloo, the first physician to complete a commercial case in the U.S., noted that the offering builds on Stryker’s Surpass Streamline. The Kalamazoo, Mich.-based company won the FDA’s nod for that product in the summer of 2018, which aimed to treat unruptured large and giant wide neck intracranial aneurysms. It was heralded as the second flow diverting stent to gain a green light in the U.S.
Now, the company has expanded on that victory. “By increasing the braid angle, the novel 64-wire device delivers excellent flow diversion and a highly flexible implant for enhanced vessel wall contact. The higher mesh density of Surpass Evolve vs. traditional 48-wire flow diverters may lead to faster aneurysm occlusion for patients," Wakhloo added.
Mark Paul, president of Stryker’s neurovascular division, told BioWorld that his company was the only manufacturer to offer two distinct flow diverters for the U.S. market. He also explained the importance of having 64 wires vs. the traditional 48, namely predictable device deployment and optimized flow diversion.
“First, every wire acts like a spring, helping open the device. With more springs, the Surpass Evolve has significantly higher opening force, which leads to a predictable deployment. Secondly, 64 wires offers consistently high mesh density. More wires lead to a finer mesh covering the neck of the aneurysm for optimized flow diversion. Higher mesh density could lead to faster aneurysm occlusion time for patients, as Dr. Wakhloo suggests, or reduce the need to layer multiple implants.”
He further noted that the initial U.S. rollout for the product is targeted, with Surpass Evolve specialist proctors providing support to ensure positive clinical outcomes. The rollout will go nationwide in the coming months.
The company also pointed out that since its European launch last year, Surpass Evolve has received approval in more than 45 countries. As a result, more than 1,500 patients have been treated with the technology.
During his company’s second-quarter earnings call July 30, Stryker CEO Kevin Lobo handled a question on pipeline delays by highlighting new approvals, to include Surpass Evolve, expressing confidence moving forward. “Our product pipelines continue to march ahead. And I think the makeup of our business being much on 510(k) gives us the ability to continue to launch products at a very healthy pace.”
The flow diverter area has been hot over the past couple of years. Just this month, Cerus Endovascular Ltd., of Fremont, Calif., and Düsseldorf, Germany-based AB Medica Deutschland Verwaltungs GmbH, a wholly owned subsidiary of Balt, reported a strategic distribution agreement providing the latter with the exclusive rights to market and sell the newly CE marked Contour Neurovascular System and the Neqstent Coil Assisted Flow Diverter devices in Germany. Terms of the agreement were not disclosed.
Montmorency, France-based Balt reported in July that it had received CE mark approval for its Silk Vista flow diverting stent for patients with unruptured intracranial aneurysms. Earlier this year, Microvention Inc., a subsidiary of Terumo Corp. based in Aliso Viejo, Calif., won a green light in the U.S. for its Flow Redirection Endoluminal Device for the treatment of brain aneurysms.
Meanwhile, early last year, Dublin-based Medtronic plc, which had a head start in the space, scored a U.S. FDA nod for an expanded indication for its Pipeline Flex embolization device, through which it could provide options for patients with small or medium, wide-necked brain aneurysms in the territory from the petrous to the terminus of the internal carotid artery.