Advertisement

June 19, 2018

Vesalio Expands European Distribution of NeVa Neurothrombectomy System

June 20, 2018—Vesalio announced that it has executed multiple exclusive distribution agreements in Europe for the company's NeVa neurothrombectomy system. The NeVa platform was designed to achieve repeatable and superior clinical outcomes by providing physicians “first pass” success in effectively capturing and retaining a neurovascular clot inside the device.

Vesalio advised that it has market coverage in 25 countries for the NeVa system, and all distribution channel partners have been trained on the NeVa platform and technique. Vesalio conducted a controlled launch in the European Union, and the company is now rapidly expanding the distribution network internationally as it moves toward full commercialization.

According to the company, the design of NeVa is effective in capturing all clot types in the first pass and has demonstrated benefit in capturing organized or hard clot types. The system's Drop Zone technology, effectively integrated clot pockets, allows NeVa to secure clots within the device.

In a preclinical study published online ahead of print in The Journal of Neuroradiology, the NeVa system showed a high rate of optimal clot integration and effective clot removal. Specifically, for challenging large organized clots, NeVa was effective in 60% of attempts compared with 10 of the current market-leading stent retrievers that all failed to remove this clot type in the model, noted the company.

Advertisement


June 20, 2018

FDA Issues Draft Guidance on Performance Tests and Labeling for Guidewires

June 20, 2018

FDA Issues Draft Guidance on Performance Tests and Labeling for Guidewires


)