Vesalio’s NeVa Net 4-mm Stroke Thrombectomy Device Introduced in Europe and International Markets

July 10, 2024—Vesalio announced the launch in Europe and other international markets of the NeVa Net 4-mm device for the treatment of acute ischemic strokes caused by large vessel occlusions.

According to Vesalio, the NeVa Net 4-mm device is designed to improve first-pass rates and reduce distal embolization. The company previously introduced the NeVa Net 5.5-mm device internationally.

The company’s NeVa and NeVa Net devices have received European CE Mark approval; they are not cleared in the United States, advised the company.

Both the newly launched 4-mm and the 5.5-mm sizes incorporate the Neva Net integrated microfilter, which is intended to prevent the escape of clot particles into new or distal territories. Distal net filtration complements the NeVa device’s “all-clots” capability, enhancing clot retention capabilities, stated Vesalio.

In the Neva Net devices, distal embolic filtration and Vesalio’s Drop Zone technologies work together to enhance clot capture and retention, providing effective recanalization in ischemic stroke thrombectomy, noted the company.

Paul Bhogal, MD, consultant interventional and diagnostic neuroradiologist at the NHS Royal London Hospital in London, United Kingdom, commented on the launch of Vesalio’s new Neva Net device in the company’s press release.

“We are excited to be among the first centers using NeVa Net,” stated Dr. Bhogal. “Our team has been eagerly anticipating the release of the 4-mm size. Our experience with NeVa has been excellent and in our cases, we are seeing very high first-pass effect (expanded thrombolysis in cerebral infarction score ≥ 2c).”

Dr. Bhogal continued, “The new NeVa Net holds much promise and the fact the 4-mm version can be used with 0.021-inch microcatheters is wonderful. I believe that this new device will, in conjunction with other technologies such as large-bore aspiration catheters and balloon guide catheters, offer the best chances of complete recanalization on first-pass and better reperfusion for the brain. My initial experience has indeed been very good, and this is effectively my go-to device for M1 and internal carotid artery occlusions.”

According to the company, the following published studies have provided promising findings for the device:

• Preclinical safety and efficacy data of the NeVa Net were published by Vania Anagnostakou, MD, et al in Journal of Vascular and Interventional Neurology (2022;14:1-16).
• An in vitro evaluation of the impact of the device’s tip design on distal embolization in mechanical thrombectomy was published online in May 2023 by Jiahui Li, PhD, et al online in the Journal of NeuroInterventional Surgery supplement for ESMINT 2023, the 15th Congress of the European Society of Minimally Invasive Neurological Therapy that was held September 4-6, 2023, in Marseilles, France.

In September 2022, Vesalio announced CE Mark approval of the first NeVa Net thrombectomy device. In October 2022, the company announced that its product line received the new European Union Medical Device Regulation certification.