Strong capability for vascular clinical studies with unique access to a world-renowned vascular lab and angiography core laboratory, a clinical research site active in over 30 cardiovascular trials, and EU MDR evidence designed the way Notified Bodies expect to read it.
Platinum Award 2026
Top prize in the xShare x European CRO Federation "EHDS & Clinical Research" Open Call, awarded to Eclevar MedTech and its Milo Health platform, presented at the EUCROF 2026 conference in Amsterdam.
Horizon Europe · Grant Agreement No. 101136734 · Amsterdam, 2 Feb 2026
Manufacturers choose Eclevar as their specialist CRO for vascular and endovascular programmes. Read all client success stories.
Dr Mark DaCosta is a cardiac surgeon and former TÜV SÜD Notified Body reviewer who has certified more than 400 cardiovascular devices in Europe. As COO and Head of the cardiovascular practice, he brings direct Notified Body insight to every vascular and endovascular assignment, so imaging endpoints, DSMB governance and PMCF design translate into approvals from the very first protocol version.
Eclevar MedTech is positioned with unique access to a world-renowned vascular lab and angiography core laboratory, and a clinical research site actively participating in over 30 cardiovascular trials. Our specialist team works with in-house clinicians in endovascular surgery and clinical investigation.
A vascular medical device is used during open surgery and endovascular techniques to control, diagnose, monitor or correct disease or injury. It encompasses cardiovascular, peripheral vascular and neurovascular anatomy.
Our team specialises in implants, endovascular prosthesis and stents intended for use in arteries and veins, collaborating with in-house clinicians specialised in endovascular surgery and clinical investigation.
Ensuring patient safety and data integrity through periodic risk-benefit evaluation and independent event adjudication.
Cardiovascular medicine is increasingly dictated by evidence-based guidelines. Our Center for Advanced Imaging assesses the imaging component of trials to ensure it is reproducible and yields the best outcomes, in collaboration with the CORRIB core lab.
Intended claims on safety and performance were not sufficiently supported by existing evidence. A comprehensive PMCF study was required under EU MDR Chapter VI and ISO 14155:2026.
Multicentre real world evidence study. 250 to 300 subjects evaluated across 8 sites, with data retrieved from medical charts from baseline to 3 years post-surgery.
Accepted by the Notified Body
Representative patient population
Validated long-term durability
Support clinical trials in the EU, UK, Australia and Japan with one partner.
Cutting-edge imaging technology in collaboration with the CORRIB core lab.
Clinical project managers specialised in complex vascular trials.
Dedicated registered nurses and technical specialists for research.
A successful track record in Data Safety Monitoring Board management.
Proprietary EDC, ePRO and e-consent technology for vascular data.
Whitepapers, client testimonials and publications produced by our teams and partners (BSI, TÜV SÜD, RegenLab).
Written with Notified Body BSI: a practical reading of the clinical evidence expectations under EU MDR 2017/745, relevant to any high risk device programme, vascular and endovascular devices included.
Eclevar manages RegenLab's PMCF programme on chronic wound devices. This is a randomized study of 160 patients across 14 sites in 5 EU countries, covering both diabetic foot ulcer (DFU) and venous leg ulcer (VLU) indications. The partnership combines Eclevar's ISO 14155 clinical expertise with the Milo Studio platform to deliver post-market clinical follow-up evidence that supports both Notified Body scrutiny and reimbursement endpoints, from protocol design through to final study report.
« Eclevar, with its tailor-made approach and advanced Milo Studio platform, represents a major strategic asset. »
A Notified Body perspective on the designation, evidence generation and conformity assessment of breakthrough devices under the EU MDR. Joint publication to come.
Dr Nikhil KhadabadiCMO · Eclevar MedTechA vascular medical device is used during open surgery and endovascular techniques to control, diagnose, monitor or correct disease or injury. It spans cardiovascular, peripheral vascular and neurovascular anatomy, and includes stents, grafts, catheters, closure devices and implants for arteries and veins.
Vascular programmes under EU MDR need imaging core lab capability, endovascular clinical expertise, robust DSMB and CEC governance and Notified Body insight. Eclevar combines access to a world-renowned angiography core lab with a clinical site active in over 30 cardiovascular trials and a former Notified Body reviewer on the leadership team.
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.
Yes. Eclevar sets up Data Safety Monitoring Boards (charter and adjudication forms, expert member selection, patient dossiers, meeting coordination) and Clinical Events Committees (event identification, clinical document retrieval, rigorous minutes and direct liaison with data management).
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.
Yes. Eclevar has delivered a multicentre real world evidence PMCF study for a Class III vascular patch, 250 to 300 subjects across 8 sites with data from baseline to 3 years post-surgery, accepted by the Notified Body under EU MDR Chapter VI and ISO 14155:2026.
Contact our vascular medical device experts to discuss your clinical trial needs and discover how Eclevar MedTech can support your regulatory success.
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