|EmboTrap--Courtesy of Neuravi|
Ireland's Neuravi is the latest entrant into the accelerating market for stent retriever devices to treat stroke by physically removing blood clots in the brain. Following a limited launch, the company announced that it has ramped up the availability of its EmboTrap Revascularization Device throughout Europe.
Neuravi CEO Eamon Brady said in an interview that the company has an 8-person sales team with a direct presence in the Nordics, Germany and France, as well as distributorship agreements in southern Europe and the Netherlands.
Its CE marked device is distinct from those made by incumbents Medtronic and Stryker because one the blood clot is captured, it is fully enclosed within the device thanks to its outer cage. In addition, the clot is trapped within the cage by an inner stent. And the company says a three-dimensional protection zone at the distal end of the device is designed to minimize risk of embolization (or a fragment of the blood clot escaping and reentering the blood stream) during clot retrieval.
"With almost 400 clinical cases in Europe, we are finding that integrating embolic protection into the EmboTrap device is a powerful strategy in helping achieve TICI 2b-3 flow restoration in one or two passes," Brady said.
Medtronic appears to agree that embolic protection is important, as evidenced by its recent $100 million deal to buy stent retriever cover maker Lazarus Effect. The Lazarus Cover is designed to reduce the loss of clot particles during stent retrieval procedures, which is a problem in 5.6% of surgeries, according to data from the startup. Its device was created to be compatible with a number of stent retrievers, including Medtronic's (formerly Covidien's) Solitaire Stent, which appears set to gain exclusive access to the technology.
|Lazarus Cover--Courtesy of Lazarus Effect|
"The Lazarus acquisition, coming immediately after the Penumbra IPO, further highlights the transformation that is taking place in the stroke market in the aftermath of six positive trials in less than 12 months," Brady said.
The acquisition could offset one of the EmboTrap's main points of differentiation.
Regardless, Neuravi expects uptake of its device to increase due to the completion of its rollout phase. Brady said the market for stent retrievers is unique in each European country, and believes Neuravi has the chance to quickly become the market leader in Belgium, where the use of the thrombectomy procedure that deploys the devices is limited compared to other European countries like Germany.
Although the company didn't indicate that the device is currently available in the U.K., Brady said Stryker and Medtronic haven't established first-mover advantage there either, and expects adoption of the new treatment paradigm to rapidly accelerate in the country, lead by his own device of course, following an expected positive recommendation from the country's federal National Institute for Health and Care Excellence (NICE).
Demand for all thrombectomy devices is expected to increase everywhere, due to 5 large, randomized studies in the New England Journal of Medicine using Medtronic's Solitaire Stent and Stryker's TrevoProvue Retriever, which conclusively proved the benefit of using devices for to treat ischemic stroke, instead of just drugs. The benefits of the devices were so clear that some of the trials had to be stopped early for ethical reasons out of consideration for those randomized into the drug-only early group.
While Stryker and Medtronic have made inroads in the U.S. market, there is plenty of room for growth, with Medtronic estimating that only 13,000 of the 240,000-plus American eligible for a stent thrombectomy procedures actually received it last year. But that was before the groundbreaking studies that are likely to make the use of devices the standard of care in patients who have a large vessel occlusion due to an ischemic stroke.
"We are excited to announce our launch and pleased that, following the compelling clinical data published earlier this year, use of thrombectomy devices for endovascular stroke therapy is on the rise, which should save and improve the lives of many patients," Brady said in a statement.
Later this year, enrollment will commence in a clinical trial of patients in a clinical trial of patients in the U.S. and Europe that's designed to achieve 510(k) clearance from the FDA to sell the EmboTrap in the U.S.
- read the release
Editor's Note: At the request of Neruravi, the third paragraph was modified to more accurately and precisely reflect the device's mechanism of action.