On December 31st 2018, the Woven EndoBridge (WEB) device by Microvention received FDA premarket approval (PMA), becoming the first and only device with PMA in the new ‘intrasaccular flow disruptors’ device category. With this novel device on the market, it could make an impact on existing aneurysm device markets such as coils and coil-assist devices in the treatment of wide-neck bifurcated aneurysms.
GlobalData estimates that the neurovascular embolization market and coil-assist device market are both growing at a Compound Annual Growth Rate (CAGR) of approximately 3%. While the overall management of aneurysms through endovascular treatment has been successfully established, wide-neck bifurcated aneurysms still present unique challenges.
Given the complicated location of the aneurysm in combination with a wide neck, surgical clipping has been shown to have the best immediate occlusion rate. However, the invasive nature of brain surgery leaves patients at higher risk of complications, morbidity, and mortality. On the endovascular side, techniques have been developed using multiple devices to overcome the challenging anatomy. Y-stenting involves the use of two coil-assist stents during coiling procedures, deployed to ensure that coils remain packed in the aneurysm. While the technique makes full use of devices with a history of proven results in aneurysm treatment, there is a risk of coil migration and other complications in wide-neck aneurysms, and the use of multiple devices also adds time and risk to the procedure.
The WEB device is a single-treatment saccular implant deployed directly in the aneurysm. The device was designed to pack the aneurysm and promote clot formation to further increase occlusion rates, while still maintaining its shape. The novel design addresses some of the limitations of surgical clipping and traditional endovascular techniques, namely, being a single-treatment minimally invasive device with high occlusion rates.
The device received CE approval in 2010 while still under Sequent Medical, and the company was acquired by Terumo Corporation (parent company of Microvention) in 2016. GlobalData believes that while usage has been scarce among European countries despite being commercially available for at least five years, the acquisition and entrance into the US market will potentially influence countries outside of the US.
This device has the potential to replace both coils and coil-assist devices, and the minimally invasive nature of this procedure could mean the replacement of surgical clipping as well. By entering the U.S. market, GlobalData expects a lot of focus to be placed on more clinical trials to prove the efficacy of this device. Should positive results be presented from multiple trials in the years ahead, the device would not only impact the US market but will make an impact on major European and Asia Pacific markets as well.