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Vascular medical device CRO with a strong capability for vascular clinical studies

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:

Vascular medical device can be defined as a device that is used during open surgery techniques. It encompasses the cardiovascular, neurovascular.
Vascular medical device can be defined as a device that is used during open surgery techniques. It encompasses the cardiovascular, neurovascular.
Vascular medical device can be defined as a device that is used during open surgery techniques. It encompasses the cardiovascular, neurovascular.
Vascular medical device can be defined as a device that is used during open surgery techniques. It encompasses the cardiovascular, neurovascular.
Vascular medical device can be defined as a device that is used during open surgery techniques. It encompasses the cardiovascular, neurovascular.
Vascular medical device can be defined as a device that is used during open surgery techniques. It encompasses the cardiovascular, neurovascular.

What is a vascular medical device?

A vascular medical device can be defined as a device that is used during open surgery techniques, as well as endovascular techniques to treat control, diagnose, monitor, or correct disease or injury. It encompasses the cardiovascular, peripheral vascular, and neurovascular anatomy. 

Meet our experienced Vascular team

The Vascular team specializes in implant, endovascular prothesis stents intended to be used in the arteries and veins for the diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease or injury, or in the investigation, replacement or modification of the anatomy in relation to the vasculature or the heart. 

We collaborate with our in-house clinicians and technical teams specialized in endovascular surgery and clinical investigation.  

ECLEVAR MEDTECH is a global medical device CRO, headquartered in Paris. We support medical device manufacturer in the MDR and IVDR transition.

FLORENCE LONGUEVILLE

Head of clinical operation

For nearly 25 years, global lead and international postmarked clinical follow-up (PMCF) projects within multicultural teams such us Terumo Aortic. Support of medical device companies on the challenges hold by clinical operations while implementation of the MDR 2017: 745.

ECLEVAR MEDTECH can support the manufacturer throughout the device life cycle. From premarket to post-market clinical follow-up activity under the EU MDR and UKCA services under the UK MDR for vascular medical device.

Examples of products we cover include: 

  • Cardiac electrophysiology and ablation catheters 
  • Catheters for intravascular and intracardiac imaging 
  • Devices for the treatment of Abdominal Aortic Aneurysms (AAA) 
  • Devices for the treatment of neurovascular diseases, including catheters, embolic coils, flow diverters, stents, and wires 
  • Devices for treatment or repair of structural heart defects or disease 
  • Drug-eluting stents, bare metal stents, and bioresorbable stents 
  • Embolic filters and IVC filters 
  • Guide catheters, balloon catheters, CVCs, introducers, filters, guidewires, PICCs, and related tools 
  • Renal artery denervation devices 
  • Transcatheter and surgical valves and related accessories 
  • Vascular closure devices 
  • Vascular grafts (textile and ePTFE) and stent-grafts 

Unrivalled Vascular Scientific Board for a better vascular clinical study

Vascular Data Safety and Monitoring Boards (DSMBs)

ECLEVAR MEDTECH will provide the following DSMB services:  

DSMB Setup Activities: 

  • Charter Development 
  • Adjudication Form Development 
  • Member Selection 
  • Contract Development & Negotiation

Per Meeting Activities: 

  • Clinical Document Retrieval 
  • Patient Dossier Development 
  • Identification of Adjudicable Events 
  • Planning & Coordination of DSMB Meetings 
  • Participation in DSMB Meetings 
  • Post-Meeting Review & Meeting Minutes 
  • Communicate DSMB Results to Sites 

Data Safety and Monitoring Boards (DSMBs), also called Data Monitoring Committees (DMCs), were introduced in first time in 1960s to ensure the safety of patient in clinical investigation. The main difference between DSMBs and other clinical oversight bodies is that a DSMB undertakes periodic risk-benefit evaluation during the medical device clinical investigation using the clinical data gathered during the study to oversight the emergence of serious or unexpected adverse outcomes.  

The DSMB shall request stopping a trial for evidence of harm.  For less serious adverse events, the DSMB may serve as a conduit for relevant information to the medical device sponsor that can trigger protocol amendments, changes in surveillance or further training of study investigators. 

Clinical Events Committee (CEC) Services

ECLEVAR MEDTECH prepares for, participates in, and works with the data management team to identify events requiring adjudication for each Clinical Events Committee (CEC) meeting. Specifically, ECLEVAR MEDTECH will provide the following CEC services: 

CEC Setup Activities: 

  • Charter Development 
  • Adjudication Form Development 
  • Member Selection 
  • Contract Development & Negotiation 

 

Per Meeting Activities: 

  • Clinical Document Retrieval 
  • Patient Dossier Development 
  • Identification of Adjudicable Events 
  • Planning & Coordination of CEC Meetings 
  • Participation in CEC Meetings 
  • Post-Meeting Review & Meeting Minutes 
  • Communicate CEC Results to Sites 
MDCG 2022-5 - Guidance on borderline medical devices and medicinal products under Regulation (EU) 2017/745

Cardiovascular CoreLab:

Cardiovascular medicine is increasingly dictated and regulated by evidence-based guidelines stemming from randomized trials and registries. The ECLEVAR MEDTECH Research Center for Advanced Imaging and Core laboratory provides cutting-edge imaging methods and decades of cardiovascular imaging expertise to assess the imaging component of these trials and registries to ensure they are reproducible and yield the best outcomes. 

Facilities include the following: 

  • Angiography Core Lab
  • Intravascular imaging core lab
  • Coronary physiology core lab
  • Comprehensive Combined Multi-modality Imaging and Simulation
  • Comprehensive statistical reporting specifically adapted for Imaging data
  • High Bleeding Risk Core Lab
  • Cardio-oncology core lab and cardiac Safety measurements
  • Conventional Echocardiography core lab
  • 4D echocardiography measurements of LV size and ejection fraction 
MDCG 2022-5 - Guidance on borderline medical devices and medicinal products under Regulation (EU) 2017/745

RWE solutions matching notified bodies expectations

Our approach allowed our clients to obtain the CE certificate under MDR.

Vascular medical device can be defined as a device that is used during open surgery techniques. It encompasses the cardiovascular, neurovascular.

Each step is handled by our team of experts (Biostatisticians, Data Analysts, Clinical Research Assistants, Clinical Project Managers) who rely on best clinical practices such as ISO14155:2020, advanced analysis techniques and a strong Quality Management System. 

A STRUCTURED Healthcare ECOSYSTEM designed for the medical device and IVD under EU MDR and UKCA regulation

Vascular medical device can be defined as a device that is used during open surgery techniques. It encompasses the cardiovascular, neurovascular.

With ECLEVAR MEDTECH, a feasibility study is conducted before engaging in RWE clinical study to ensure the quality and quantity of data. It is important to demonstrate that the data source is of sufficient quality and quantity for the intended use. The advantages of using RWD as a valid PMCF activity are of no relevance if the data source is of poor quality, as reliable decisions cannot be made based upon an unreliable data source. 

Case Studies:

The medical device:

vascular prostheses made of knitted polyester fabrics, in straight tubular shapes, impregnated with ultra-purified collagen of bovine origin, and are indicated for replacement or bypass of arteries damaged by an aneurysm or arterial occlusive disease.
 

Problem:

As shown by the Clinical Evaluation Report, intended claims on clinical safety and performance are not sufficiently supported by existing clinical evidence. To maintain a “
Vascular patch “in the European market, the sponsor has to conduct a PMCF study to generate sufficient clinical data in accordance with “Chapter VI – Clinical Evaluation and Clinical Investigations, specifically sections 62 – 82”. As well as ISO 14155:2020.  

Objectives 

  • Confirming safety and performance of the Vascular device throughout its expected lifetime and both anatomic locations: Carotid and femoral. 
  • Identifying and analysing emergent risks based on factual evidence. 
  • Ensuring the continued acceptability of the benefit-risk ratio referred to in EU MDR. 
  • Identifying possible systematic misuse or off-label use of device X to verify that the intended purpose is correct. 
Vascular medical device can be defined as a device that is used during open surgery techniques. It encompasses the cardiovascular, neurovascular.

Methodology  

A Sponsor conducted RWE multicentre study to collect clinical data for Vascular patch. The objective was to examine short and long-term outcomes of using the device when exposed to a larger and more varied population. 

All data were retrieved from medical charts for each patient from the time of surgery (considered as the baseline of study) until a maximum of 3 years after surgery. 

A minimum of 250 up to a maximum of 300 subjects were evaluated from 3 to 8 different sites. At least 100 subjects were evaluated in carotid location and at least 100 in femoral location. 

Hospital network involved: 

 

Our KOLs Involved in the study: 

  • Prof.Yann Goueffic  
  • Prof. Blandine Maurel-Desanlis 
  • Dr. Bahaa NASR 

Benefits 

  • Contribute to a larger body of evidence being developed: 
  • Representative population 
  • Accepted by the notified body. 

Applicable regulation and guideline: 

  • Article 61, Annex I and Annex XIV of the Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices (MDR), 
  • ISO 14155:2020-07 (section 6.3, Justification for the design of the clinical investigation) Clinical investigation of medical devices for human subjects — Good clinical practice. 
  • Regulation EU 722/2012: Regulation (EU) concerning particular requirements regarding the requirements laid down in Council Directives 90/385/EEC and 93/42/EEC concerning active implantable medical devices and medical devices manufactured utilizing tissues of animal origin. 
  • NF EN ISO 7198: 2017- Cardiovascular implants and extracorporeal systems. Vascular prostheses. Tubular vascular grafts and vascular patches. 

Reasons to work with ECLEVAR MEDTECH
for Vascular Medical Devices

Global market access

We are a global organization, trusted and recognized around the world. ECLEVAR MEDTECH can support clinical trials in EU, UK, Australia and Japan.

Vascular Corelab:

We are equipped with cutting-edge technology in the vascular area in collaboration with CORRIB Lab.

Experience and product expertise

The benefits of having experienced, professional and well-qualified technical specialists cannot be overstated in the complex and ever-changing medical device industry. Our Clinical project managers are specialized and experienced with Vascular clinical trials.

Vascular medical device can be defined as a device that is used during open surgery techniques. It encompasses the cardiovascular, neurovascular.

In-house registered
nurses and tech

Vascular DSMB

Vascular Expertise

As vascular medical device CRO, we have successfully conducted complex vascular projects. See clinical trial.gov below: -Vascular Stent -Endovascular protheses

In house cutting edge dedicated EDC and ePRO technology and e-consent.

PMCF SURVEYS - Eclevar MedTech
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