Qu’est-ce qu’un dispositif médical vasculaire ?
Un dispositif médical vasculaire est utilisé lors d’une chirurgie ouverte ou de techniques endovasculaires afin de contrôler, diagnostiquer, surveiller ou traiter une maladie ou une lésion. It spans cardiovascular, peripheral vascular and neurovascular anatomy, and includes stents, grafts, catheters, closure devices and implants for arteries and veins.
Why choose a specialist vascular device CRO in Europe?
Vascular programs under EU MDR need imaging core lab capability, endovascular clinical expertise, robust DSMB and CEC governance and Notified Body insight. Eclevar combines access to an angiography core lab with a clinical site active in over 30 cardiovascular trials and a former Notified Body reviewer on the leadership team.
What core lab capabilities does Eclevar offer for vascular trials?
Angiography core lab, intravascular and echocardiography lab, coronary physiology core lab and 4D echocardiography for left ventricular size and ejection fraction, delivered so the imaging component of a trial is reproducible and yields the best outcomes.
Does Eclevar provide DSMB and Clinical Events Committee services?
Yes. Eclevar sets up Data Safety Monitoring Boards (charter and adjudication forms, expert member selection, participant dossiers, meeting coordination) and Clinical Events Committees (event identification, clinical document retrieval, rigorous minutes and direct liaison with data management).
Which vascular devices does Eclevar cover?
Cardiac ablation and intravascular imaging catheters, AAA treatment devices, neurovascular flow diverters, drug-eluting and bare metal stents, embolic and IVC filters, balloon catheters and guidewires, transcatheter and surgical valves, vascular closure devices, ePTFE grafts and textile stent-grafts.
Can Eclevar run a PMCF or real world evidence study for a Class III vascular device?
Yes. Eclevar has delivered a multicenter real world evidence Étude PMCF for a Patch vasculaire de classe III, 250 to 300 subjects across 8 sites with data from baseline to 3 years post-surgery, under EU MDR Chapter VI and ISO 14155:2026.
