Vesalio Announces NeVa™ Stroke Treatment Product CE Mark Certification
Vesalio announces the CE Mark certification of its first product line, the proprietary NeVa™ neurothrombectomy platform for the treatment of stroke.
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News
Positive Results in Early NeVa™ Human Thrombectomy Procedures
Vesalio announces it has completed European enrollment of the first twenty-five human cases in a post-market registry of the proprietary NeVa™ neurothrombectomy platform for the treatment of stroke.
Vesalio Reports Expansion of Commercial Distribution, Additional Published Data on the NeVa™ System
Vesalio announces it has executed multiple exclusive distribution agreements in Europe and now has market coverage in 25 countries for the NeVa Neurothrombectomy System.
Vesalio Initiates Full Commercial Launch of NeVa at the 10th Anniversary of ESMINT
Vesalio announces it has initiated the full commercial European launch of its NeVa neurothrombectomy platform at the 10th annual congress of the European Society of Minimally Invasive Neurological Therapy.
NeVa™ Drop Zone Effect – Initial Experience Presented at ABC Win
On January 18, 2019, Professor Serdar Geyik (Istanbul Istinye University) presented his early NeVa experience at the ABC-WIN Seminar in Val D’Isere, France.
NeVa™ First Clinical Experience Data Presented at the International Stroke Conference
From Val D’Isere, France to Honolulu, Vesalio’s early clinical experience data is being presented globally.
Expansion of International Distributor Network and Stroke Congress Exhibition Presence
Vesalio announces it has executed multiple exclusive distribution agreements in Europe, Latin America, Asia and the Middle East and now has market coverage in 39 countries for the NeVa™ Neuro-thrombectomy System.
Vesalio and Vassa Medical celebrate NeVa™ Launch in Mirano, Italy
On April 5th, the Vassa Medical national sales network convened to celebrate the Italy launch of NeVa at the company’s headquarters in Mirano near Venice. Dr. Massimo Sponza from Udine Hospital was present to train the team on acute ischemic stroke and thrombectomy.
Vesalio™ Secures $5 Million Investment Capital Funding
Vesalio announces it has recently raised $5 million in funding. The capital will support the continued global expansion of the NeVa™ Neurothrombectomy System, finance key clinical studies and launch new product introductions.
Vesalio Obtains Additional CE Approval for New Products, NeVa™ Clinical Data Published
Vesalio announces it has obtained its second CE Approval spanning multiple new NeVa™ product designs and technology. The new generation NeVa devices expand on the Drop Zone™ and Smart Marker™ technologies.
VESALIO Mood: Elated, Excited and Ready to Rock in 2020
As the end of 2019 approaches, we reflect with pride and gratitude on what we achieved: We saw the publication of our First in Man data and initiated our regulatory enabling studies, We received our 2nd CE mark on the expanded #NeVa platform, including designs with more Drop Zones, We organized 5 Vesalio Clot Interaction…
Another Successful Vesalio™ Clot Interaction Workshop in Barcelona
On January 22 and 23, a diverse group of physicians from 8 different countries trained on new approaches for clot retrieval with the NeVa™ Drop Zone Retrieval Technique at the Vesalio Clot Interaction Workshops that took place at the Vall d’Hebron Research Institute.
Initiates Virtual Training and Announces Pass Effect Rate Publication
Vesalio announces it has executed additional exclusive distribution agreements in Europe, Latin America, Asia, and the Middle East. With these new partnerships, the NeVa™ Thrombectomy System has gained market coverage in 53 countries.
Vesalio Reports 2,500 Patient Milestone
Vesalio reports it has surpassed 2,500 clinical cases with the NeVa™ neuro-thrombectomy platform. Physicians have evaluated the Neva Drop Zone™ technology with enthusiasm as it has shown a unique capability of removing the full spectrum of clot types in large vessel occlusion ischemic stroke.
Vesalio Receives Peripheral FDA 510k Clearance and Additional CE Approval
Vesalio reports it has obtained an FDA 510k clearance and its 4th CE approval. The FDA 510k indication is for the removal of thrombi in peripheral blood vessels.
Vesalio Attains Key FDA Clinical Study Milestone
Vesalio announces it has accomplished a key FDA IDE study milestone to support entry into the US neurovascular market. Enrollment in the VITAL 1 clinical trial, assessing the company’s NeVa VS™ technology in the treatment of symptomatic cerebral vasospasm following aneurysmal subarachnoid hemorrhage (aSAH), has been completed.
Vesalio Initiates FDA IDE Stroke Study
Vesalio announces another key milestone to support entry into the US neurovascular thrombectomy market. Enrollment has commenced in the Vesalio CLEAR acute ischemic stroke FDA IDE clinical trial utilizing the NeVaTM thrombectomy technology platform.
Vesalio Secures Class A Funding
Vesalio announces it has successfully secured a Class A financing round. The proceeds will be utilized to support the ongoing US IDE stroke study, establish US infrastructure, expand its innovative product portfolio, and scale international business.
Vesalio Initiates Clinical Study Evaluating Innovative Thrombectomy Technique for Patients with STEMI
Vesalio announced the start of enrollment in its NATURE study using enVast™, the company’s first thrombectomy system for patients presenting with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention.
Vesalio Announces Appointment of Mike Kujak as its New Independent Board Chairman
As an independent board chairman, Mike Kujak will bring expert knowledge and know-how from his years of leadership in the medical device start-up space.
Vesalio Announces Earl Slee as New Board Observer and Senior Advisor to the Company
As a board observer and senior advisor to the company, Earl Slee brings extensive medical device innovation and business development expertise.
Vesalio Announces Completion of Enrollment in its FDA Enabling Stroke Study
Vesalio announces the completion of enrollment in its FDA IDE clinical study for acute ischemic stroke.
Vesalio announces oversubscribed Class A financing
Vesalio, an emerging leader in improving outcomes in patients with vascular occlusion, is proud to announce it has oversubscribed its Class A financing round.
NeVa: More & More are Training to #DoTheDropZone
A growing number of European & Middle Eastern doctors and stroke teams are training to #DoTheDropZone with NeVa, a revolutionary thrombectomy device with high first pass rates.
Vesalio announces CE Approval for new NeVa NET™
The first integrated clot micro-filtration technology for stroke thrombectomy patients.
Vesalio announces FDA Approval of the NeVa VS™
NeVa VS is a patented retrievable nitinol stent specifically designed to treat cerebral vasospasm after aneurysmal rupture.
Vesalio announces EU MDR Certification
MDR certification confirms the company’s commitment of ensuring that their innovative new products meet or exceed these rigorous new standards.
Vesalio appoints VP of U.S. Sales and announces recent publication on NeVa showing impressive first pass rates
Vesalio hires Bob Bushok as VP of U.S. Sales and announces high first-pass rates and favorable safety profile in a 145-stroke patient data set for the NeVa™ thrombectomy device with findings published in the journal Interventional Neuroradiology.
Vesalio Announces Initial Use of its Uniquely Designed and FDA-approved NeVa VS Device
Vesalio Introduces pVasc™ U.S. Clinical Study to capture real-world data and optimize results for patients suffering from peripheral vascular disease.
NeVa CLEAR Study results presented at ESMINT: innovative thrombectomy device achieves notable first-pass success and patient outcomes
Primary results from the CLEAR Study were presented at the ESMINT annual meeting in Marseille, France (4-6 September 2023), where Vesalio also announced the fifth anniversary of the international commercialization of the NeVa™ device.
Vesalio appoints CFO and announces company headquarters in Dallas, Texas
Introducing pVasc™ mechanical thrombectomy system for the safe and effective non-surgical removal of occlusions from the peripheral vasculature
VESALIO Introduces NeVa NET 4.0 mm Following International Success of NeVa NET 5.5 mm
Vesalio hires Bob Bushok as VP of U.S. Sales and announces high first-pass rates and favorable safety profile in a 145-stroke patient data set for the NeVa™ thrombectomy device with findings published in the journal Interventional Neuroradiology.
Vesalio launches pVasc Thrombectomy System in the U.S. for peripheral occlusions
Introducing pVasc™ mechanical thrombectomy system for the safe and effective non-surgical removal of occlusions from the peripheral vasculature
Vesalio Announces Launch of pVasc Study in the U.S. While Featuring the pVasc Thrombectomy System at VIVA, VEITH, and TCT
Vesalio Introduces pVasc™ U.S. Clinical Study to capture real-world data and optimize results for patients suffering from peripheral vascular disease.
