Tag: Vesalio

Vesalio announces presentation of positive CLEAR study results at ESMINT 2023

Vesalio has announced the recent presentation of key findings from the CLEAR study—a prospective, multicentre, open-label, single-arm, US Food and Drug Administration (FDA)-regulated investigational...

Vesalio announces successful initial use of NeVa VS device in USA

Vesalio has announced the successful initial use of its NeVa VS device in the USA for the treatment of post-aneurysmal subarachnoid haemorrhage (aSAH) cerebral...
vesalio

Vesalio appoints VP of US sales, announces publication of “impressive” first-pass...

Vesalio has today announced the appointment of a new vice president (VP) of US sales, Bob Bushok, who will oversee commercial strategy and execution...
vesalio

Vesalio announces EU MDR certification of neurovascular product lines

Vesalio has announced EU Medical Device Regulation (MDR) certification of its product lines—achieving this “significantly ahead” of its May 2023 deadline, according to a...

Vesalio announces US FDA approval of NeVa VS to treat cerebral...

Vesalio has announced US Food and Drug Administration (FDA) humanitarian device exemption (HDE) approval for commercialisation of its NeVa VS device, which is indicated...

Vesalio gains CE-mark approval for new “one-of-a-kind” NeVa NET thrombectomy device

Vesalio has today announced receipt of CE-mark approval for commercialisation of its new NeVa NET, which the company claims is the “first and only”...

Vesalio announces oversubscribed Class A financing

Vesalio recently announced that it has oversubscribed its Class A financing round. Solas BioVentures led the investment with participation by new and existing investors,...
vesalio

Vesalio announces completion of enrolment in acute ischaemic stroke IDE study

Vesalio has announced the completion of patient enrolment for the CLEAR US Food and Drug Administration (FDA) investigational device exemption (IDE) study utilising the NeVa...
vesalio

Earl Slee joins Vesalio as new board observer and senior advisor...

Vesalio has announced the addition of Earl Slee as a board observer and senior advisor to the company, effective immediately. According to a company...

Vesalio initiates clinical study evaluating enVast thrombectomy system in patients with...

Vesalio recently announced the start of enrolment in its NATURE study using enVast, the company’s first thrombectomy system for patients presenting with ST-segment elevation...
funding

Vesalio secures Class A funding to bolster stroke treatment portfolio

Vesalio has successfully secured a Class A financing round. The company claims this funding will be utilised to support its ongoing US Investigational Device...
vesalio

Vesalio initiates new FDA stroke study following “milestone” VITAL trial enrolment

US medical device company Vesalio has announced the start of enrolment in the Vesalio CLEAR study—an acute ischaemic stroke FDA investigational device exemption (IDE)...

Vesalio receives peripheral FDA clearance and CE mark 

Vesalio has announced in a company press release that it has received 510(k) clearance from the US Food and Drug Administration (FDA) and its...

Vesalio expands distribution network, broadens virtual physician training and announces high...

Vesalio has announced it has expanded the distribution of the NeVa Thrombectomy System, gaining market coverage in 53 countries in Europe, Latin America,...

Vesalio secures US$5 million investment capital funding

Vesalio announces it has recently raised US$5 million in funding. The capital will support the continued global expansion of the NeVa Neurothrombectomy System, finance...

Vesalio reports expansion of international distributor network and Stroke Congress Exhibition...

Vesalio has announced that it has executed multiple exclusive distribution agreements in Europe, Latin America, Asia and the Middle East and now has market...

Vesalio initiates full commercial launch of NeVa

  NeVa next-generation neurothrombectomy system Vesalio has announced that it has initiated the full commercial European launch of its NeVa neurothrombectomy platform at the 10th annual...

Vesalio reports expansion of commercial distribution and additional published data on...

Vesalio has executed multiple exclusive distribution agreements in Europe and now has market coverage in 25 countries for the NeVa Neurothrombectomy System, it has...

Vesalio reports positive results in early NeVa human thrombectomy procedures and...

Vesalio has announced that it has completed European enrolment of the first twenty-five human cases in a post-market registry of the proprietary NeVa neurothrombectomy...