Vesalio Secures CE Mark for Neurovascular Devices Targeting Cerebral Vasospasm and Stroke Treatment
核心洞察
Vesalio (搜索) received CE Mark certification for NeVa VS (搜索), a device treating cerebral vasospasm (搜索) following aneurysmal subarachnoid hemorrhage (搜索), offering a safer alternative to balloon angioplasty with 93.2% of treated vessels requiring no further intervention.
The company also obtained CE Mark for NeVa 3.0 mm Thrombectomy System (搜索), extending its proprietary Drop Zone technology to smaller, more tortuous arteries for broader stroke (搜索) treatment applications.
Additional FDA 510(k) clearance expanded indications for Vesalio (搜索)'s aspiration catheters to include distal access with microcatheter delivery, enhancing versatility across neurovascular and peripheral interventions.
Vesalio (搜索) announced CE Mark certification and European commercial launch of two neurovascular devices designed to address critical unmet needs in cerebral vasospasm (搜索) and stroke (搜索) treatment. The company also received expanded FDA 510(k) clearance for its aspiration catheters, marking significant regulatory progress for the Texas-based vascular intervention specialist.
NeVa VS Addresses Critical Vasospasm Treatment Gap
The NeVa VS (搜索) device targets cerebral vasospasm (搜索) following aneurysmal subarachnoid hemorrhage (搜索) (aSAH), a serious and potentially life-threatening condition associated with delayed cerebral ischemia (搜索) and neurological decline. Already FDA approved under a Humanitarian Device Exemption (HDE), the device now gains European market access through CE Mark certification.
Clinical data from the VITAL study demonstrate strong performance in refractory vasospasm, with 93.2% of treated vessels requiring no further intervention. This positions NeVa VS (搜索) as a potential definitive therapeutic option, offering a safer alternative to balloon angioplasty while preserving distal blood flow during treatment of critically narrowed vessels.
"I use NeVa VS (搜索) regularly—it's safe, more controlled, and preserves flow where traditional angioplasty cannot," said Dr. Ameer Hassan from Harlingen, Texas. "We've seen exceptional clinical outcomes with no recurrence of vasospasm in some very critical cases."
Expanded Stroke Treatment Portfolio
The NeVa 3.0 mm Thrombectomy System (搜索) extends Vesalio (搜索)'s proprietary Drop Zone technology to smaller, more tortuous arteries, broadening the company's stroke (搜索) treatment capabilities. This expansion increases the number of patients who may be eligible for mechanical thrombectomy using the NeVa platform, delivering proven all-clot capability and high first-pass success to a broader patient population.
"3.0 mm NeVa is a welcome addition to the Vesalio (搜索) stroke (搜索) portfolio," said Dr. Roland Schwab, Interventional Neuroradiologist from Magdeburg, Germany. "I look forward to evaluating its impact in cases where NeVa was previously not an option."
Enhanced Catheter Versatility
Vesalio (搜索)'s additional FDA 510(k) clearance expands labeled indications for its neurovascular and peripheral aspiration catheters to include distal access with microcatheter delivery. This regulatory milestone enhances the versatility of the company's catheter portfolio across neurovascular and peripheral interventions.
Strategic Commercial Positioning
"These approvals mark our seventh CE certification and reflect the continued growth and strategic refinement of Vesalio (搜索)'s neurovascular portfolio on a global scale," said Diane Demet Tangun, Vice President of Market Development at Vesalio. "They reinforce our commitment to delivering specialized solutions for complex vascular conditions and to supporting physicians with technologies designed for real-world clinical challenges."
The regulatory achievements position Vesalio (搜索) for expanded global reach, building on its track record of treating more than 15,000 patients across over 60 countries. Founded in 2017, the privately held medical device company focuses on advancing patient care in thromboembolic vascular disease (搜索) through its proprietary NeVa, enVast, and pVasc platforms designed to remove all types of clots and restore vital blood flow to compromised ischemic tissue in the brain, heart, and peripheral anatomy.
"These milestones reflect Vesalio (搜索)'s continued drive to expand access to our technologies globally," stated Steve Rybka, Chief Executive Officer of Vesalio. "They highlight the breadth and adaptability of our portfolio as well as position Vesalio to advance to the next phase of our commercial growth following the regulatory clearances achieved late last year."