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Therapeutic Areas Neurovascular

Neurovascular

Innovation in neurovascular medicine saves lives, restores function, and redefines recovery for patients worldwide. Yet, the path to market for these technologies demands exceptional precision, both in the device and in its development.

Connect with Our Neurovascular Experts

Magnetic resonance angiography

Advancing Neurovascular MedTech

Avania is a MedTech-focused CRO with deep neurovascular expertise and an established global network of leading surgeons, interventional radiologists, and stroke centers. With more than 50 neurovascular trials conducted to date — including 30+ in acute ischemic stroke — our teams understand the urgency, complexity, and scrutiny of this field.

From Pre-CE and First-in-Human (EFS) through pivotal and post-market studies, Avania delivers integrated solutions that minimize risk, accelerate timelines, and maintain the highest standards of quality and compliance.

Medical Hospital Research Lab

Navigating the Unique Challenges of

Neurovascular Device Development

Every neurovascular device study requires a balance of technical precision, patient safety, and rapid response. Avania’s dedicated teams bring the experience and infrastructure to manage these intricate studies end-to-end.

  • Complex Procedures: Neurovascular interventions demand flawless execution and coordination across multidisciplinary teams.
  • Imaging-Intensive Studies: Our workflows integrate core lab partnerships and neuro-specific data management for high-fidelity imaging analysis.
  • Rigorous Regulatory Oversight: IDE, PMA, and EU MDR pathways for neurovascular devices are among the most demanding in MedTech. Avania helps sponsors navigate them with clarity and confidence.
  • Extended Follow-up: Our teams are adept at managing long-term neurological tracking, capturing safety events and functional outcomes over time.
  • MedTech Focus: Unlike pharma-first CROs, Avania’s processes, technology, and people are built entirely around the nuances of device innovation, ensuring efficiency where it matters most.

Unparalleled Expertise:

Meet Our Neurovascular MedTech Veterans

silvia casellas

Director of Project Management, EU

Silvia Casellas, MS

  • 25+ years in MedTech clinical research and full-scope international trial oversight across 25+ countries
Michelle Michela

Principal Consultant (US)

Michelle Michela, MS

  • 30+ years in clinical trial design, safety oversight, and FDA submissions
  • 15+ successful PMAs
Bonnie Weiner

Medical Director (US)

Dr. Bonnie Weiner, MD

  • 30+ years experience in clinical oversight and imaging-based workflow development
  • Cardiologist in Worcester, MA, affiliated with St. Vincent Hospital
  • Supports safety oversight at Avania and manages core imaging laboratory operations
sujith shetty

VP Cardiovascular & Neurovascular Franchise Head (US)

Dr. Sujith Shetty, MBBS

  • 20+ years of experience leading pre-market and pivotal studies through FDA approval
  • Previously served as a research fellow at USC Keck School of Medicine
  • Led initiatives within the FDA’s EFS, EAP, and Payor Communication programs
neus rolden

Senior Project Manager, Neurovascular

Neus Roldan

  • 20+ years of experience leading global neurovascular programs

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The Avania Team Advantage

Avania’s neurovascular programs are guided by veteran physicians, regulatory strategists, and clinical operations leaders who have worked across every phase of device development. Each project team provides direct access to subject matter experts and senior leadership, ensuring transparent collaboration and consistent, high-quality execution.

Project manager and teammates smiling cheerfully at team meeting in boardroom

Deep Therapeutic & Industry Insight

Our specialists bring firsthand experience from device companies, research hospitals, and regulatory agencies, combining clinical understanding with commercial acumen. They are steeped in neurovascular indications including ischemic stroke, aneurysm, AVM, and carotid disease, allowing them to anticipate challenges and align studies with regulatory expectations.

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Consistent, Dedicated & Flexible Teams

With low staff turnover and a culture of accountability, Avania ensures continuity from startup through closeout. Our clients view us as an extension of their internal team, valuing our responsiveness, adaptability, and shared commitment to study success.

Touching base with the medical team

Integrated Solutions for Neurovascular Innovation

Avania delivers full lifecycle support for neurovascular technologies—combining regulatory, clinical, and commercial insight to streamline the path from concept to market success.

Strategic Consulting & Regulatory Pathways

Early strategic planning is critical in this high-stakes field. Avania’s regulatory team provides expert guidance for IDE, PMA, EU MDR, and indication expansion submissions, with a track record of hundreds of successful FDA and international interactions.

Our consultants help sponsors anticipate challenges, structure effective evidence packages, and accelerate agency feedback cycles.

Clinical Development & Execution

Neurovascular studies require orchestration across sites, imaging partners, and safety committees. Avania’s operational teams bring deep experience managing these complex ecosystems:

  • Proven success executing multicenter, imaging-intensive neurovascular trials.
  • Coordination of site management, data monitoring, imaging workflows, CEC and DMC oversight.
  • Global relationships with 80+ neurovascular centers and stroke teams.
  • Focus on data integrity, patient safety, and regulatory compliance.
  • Real-time data visualization and reporting tools to maintain oversight and transparency.

Our Track Record

Demonstrated Success in Neurovascular

Avania’s neurovascular experience reflects both scale and specialization, spanning more than 50 trials across ischemic and hemorrhagic stroke, aneurysm, AVM, and carotid disease. Our programs have guided clients through early feasibility, pivotal studies, and PMCF requirements under EU MDR.

Technologies Supported

  • Balloon and delivery catheters
  • Clot retrievers and embolic protection devices
  • Flow diverters, microcatheters, and guidewires
  • Neurovascular stents and atherectomy catheters
  • Imaging-enabled diagnostic and navigation systems

Clinical Scope

  • Pre-market (Pre-CE, FIH/EFS, pivotal) through post-approval and indication expansion IDEs
  • Custom workflows for patient selection committees, imaging core labs, CEC/DMC oversight, and regulatory review
  • Seamless integration of imaging and procedural data into secure, compliant EDC systems

Representative Indications

  • Acute ischemic stroke and mechanical thrombectomy
  • Cerebral aneurysm repair and embolization
  • Arteriovenous malformations (AVM)
  • Carotid revascularization and neuroprotection
  • Intracranial atherosclerosis and vessel remodeling

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Client

Successes

Our clients consistently highlight our ability to “understand the unique demands of interventional studies” and to “navigate the operational and regulatory complexity of neurovascular trials with precision and care.”

With over 900 MedTech projects, 500+ regulatory submissions, and 25+ Breakthrough Device designations supported globally, Avania gives sponsors the confidence to bring transformative neurovascular innovations to market faster, and with less risk.

“Working with Avania has been a consistently positive experience. As both a principal investigator and a consultant, I’ve seen firsthand how their partnership-driven approach translates into smooth, well-executed trials. Their team is collaborative, responsive, and deeply knowledgeable — especially in the neurovascular space where precision and coordination are critical. Avania doesn’t just manage studies; they build relationships and deliver results with professionalism and attention to detail.”

Dr. Tudor Jovin, MD
Chairman and Chief of Neurology and Medical Director of the Cooper Neurological Institute
cooper university healthcare logo

Case Study

Advancing cSDH Treatment Through Expert-Led First-in-Human Success

Device:

Liquid embolic material for treatment of chronic subdural hematoma (cSDH)

Solution:

Strong site engagement, physician education support, and close collaboration with neurointerventional thought leaders throughout the enrollment and follow-up of patients in Australia

Problem:

Complex enrollment and study procedure requiring local field clinical support and expertise of neurointerventional specialists

Outcome:

Successfully completed feasibility and safety in first-in-human use and initiated the multicenter expansion based on positive early data. Received ethics and regulatory approvals in Australia within 3 months

Case Study

Achieving Global Approvals Through Sustained Neurovascular Trial Engagement

Device:

Flow diverter stent to treat unruptured large and giant wide neck intracranial aneurysms

Solution:

Strategic monitoring visit schedule through long-term follow-up to keep sites engaged. Detailed instructions for data collection and regular re-trainings

Problem:

Long-term follow-up with risk of patient fall-out and complex data collection with variation across sites

Outcome:

PMA approval and panel ‘Yes’ vote, successful long-term follow-up data collection that supported a PMDA Japan approval as well

Partner with Avania’s

Neurovascular Experts Today

Neurovascular innovation demands precision, partnership, and deep therapeutic understanding. Avania’s MedTech focus, veteran teams, and proven processes make us the trusted choice for device and diagnostic development across every stage of the journey.

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