NEWS

NeVa CLEAR Study results presented at ESMINT: innovative thrombectomy de...

DALLAS, TEXAS- (September 21, 2023) – The NeVa CLEAR Study is a prospective, multicenter, open-label, single-arm, FDA-regulated IDE trial evaluating the safety and effectiveness of Vesalio’s technologically advanced NeVa device, renowned for its capacity to retrieve all clot types in large vessel occlusion (LVO) stroke. Primary results from the study were presented at the ESMINT annual meeting in Marseille, France (4-6 September 2023), where Vesalio also announced the fifth anniversary of NeVa’s international commercialization, making this milestone a dual celebration for the Vesalio team.

SENSOME and ASAHI INTECC forge partnership to develop next-generation sm...

PARIS, FRANCE - JUNE 21ST , 2023 – Pioneering smart medical device company, Sensome, and worldleading Japanese guidewire company, Asahi Intecc, are announcing today a collaboration to develop the next generation Clotild® Smart Guidewire, with Asahi Intecc taking on the manufacturing role for this groundbreaking device destined for the treatment of acute ischemic stroke.

Scientia Vascular Receives FDA Clearance for Aristotle Colossus, the Onl...

SALT LAKE CITY, UTAH – March 9, 2023  Scientia Vascular, a leader and pioneer in differentiated neurovascular access technology, announces FDA 510k clearance of the Aristotle Colossus macrowire. Like its predecessors the Aristotle 18 and Aristotle 24 that have expanded treatment options in thousands of procedures to date, Aristotle Colossus utilizes breakthrough microfabrication design technology. This advancement in manufacturing allows for a soft, atraumatic tip and is designed to support the tracking of large bore catheters to the treatment site and drive superior navigability of distal, tortuous anatomy. The combination of these benefits for patients and clinicians will impact a myriad of procedures in both ischemic and hemorrhagic stroke care. 

VESALIO Announces Initial Use of its Uniquely Designed and FDA-approved...

Nashville, Tennessee - (FEB 23, 2023) – VESALIO announces the successful initial use of its NeVa VS device in the United States for the treatment of post-aneurysmal subarachnoid hemorrhage (aSAH) cerebral vasospasm. Vasospasm is the most common complication of aSAH and is the main cause of delayed morbidity and mortality. NeVa VS is the only FDA-approved device for this indication and the only device on the market specifically designed to treat life-threatening vasospasm.

Phenox Inc. announces the presentation of the PROST Clinical Trial at th...

[Irvine, CA] - phenox Inc. a leading medical device company in the Neurovascular industry, announced the presentation of the primary results of The pRESET for Occlusive Stroke Treatment (PROST) Randomized Clinical Trial at the International Stroke Conference in Dallas, TX on February 8th at 9:30am CST. This highly anticipated event marks a significant milestone in the company's efforts to advance the treatment of occlusive stroke.

Phenox Inc. a Wallaby Medical Company, announces the FDA 510k Clearance...

Phenox Inc., a leading medical device company in the Neurovascular industry, announced today that its pRESET Thrombectomy Device has received FDA clearance for use to treat acute ischemic stroke. The pRESET product family, which has been available in Europe for over 10 years, is now cleared for use in the United States.

Vesalio appoints VP of U.S. Sales and announces recent publication on Ne...

Nashville, Tennessee - (NOV 29, 2022) – VESALIO is pleased to welcome Bob Bushok as Vice President of U.S. Sales overseeing commercial strategy and execution for the NeVa VSTM vasospasm launch and the expected 2023 introduction of NeVa™ thrombectomy platform into the U.S. market. Bob will be responsible for building the U.S. sales team and will play a pivotal role in continuing to grow the company through strategic initiatives.

Vesalio announces EU MDR Certification

Nashville, Tennessee - (OCT 13, 2022) – VESALIO announces the EU MDR certification of its product lines significantly ahead of the May 2023 deadline. This important milestone marks the third in a series of recent regulatory achievements along with the CE marking of NeVa NET™, VESALIO’s new, flagship neuro-thrombectomy device containing a unique integrated distal filter technology and the FDA HDE approval of NeVa VS™, indicated for the adjunctive treatment of aSAH-induced cerebral vasospasm. NeVa VS is the first medical device approved in the U.S. for this indication.

Vesalio announces FDA Approval of the NeVa VS™ to treat cerebral vasospa...

Nashville, Tennessee - (Sept 15, 2022) – Vesalio announces FDA HDE approval for commercialization of NeVa VS, indicated for the adjunct treatment of symptomatic cerebral vasospasm (CV) following aneurysmal subarachnoid hemorrhage (aSAH), the major cause of death and disability in this patient population.  This is the first intracranial technology approved for this indication in the U.S.

Wallaby / phenox announces global launch of the pEGASUS HPC Stent System...

Nice, France (September 7, 2022). Wallaby / phenox has announced the successful global launch of their novel pEGASUS HPC stent at the ESMINT 2022 congress in Nice, France. The introduction of the pEGASUS stent enables more patients to benefit from the HPC surface modification in stent-assisted coiling treatments as well as intracranial atherosclerotic diseases (ICAD) and dissections. The application of the surface modification to the stent results in enhanced safety by significantly reducing thrombogenic complications.