Vascular Imaging Core Laboratory (VasCore)

About

The Vascular Imaging Core Laboratory (VasCore), a division of the Massachusetts General Hospital Physicians Organization, is committed to helping you navigate the process from the development of a vascular device through regulatory approval and post-market studies. Since 1997, VasCore has been a leader in strategic development of imaging protocols and the interpretation of ultrasound, radiographic and other imaging modalities as part of novel vascular device trials. The process can be overwhelming, and some of the services we offer include:

• Determining the type of trials needed to evaluate your product
• Analyzing its efficacy
• Recommendations for presenting to regulatory agencies
• Protocol and document development
• Data acquisition and analysis
• Site performance assessment
• Site and investigator training
• Data storage and archiving
• Collaboration on publications

At VasCore, we have the highest commitment to quality performance and improvement. We work closely with external quality assurance experts from Avania, renowned leaders in quality oversight and assurance. Avania conducts routine internal audits of our quality systems and standard operating procedures. We actively monitor our performance and make regular improvements to ensure that we continue to practice using industry leading quality processes.

Services

We offer a wide range of services for a smooth road to approval. For more than 20 years VasCore has been helping clients successfully navigate the evaluation process for novel vascular devices. From specifying what kind of trial is necessary in order to analyze a product, to examining its effectiveness, to presenting results to regulatory agencies in the U.S. and internationally, VasCore knows how to guide you through every step of the process.

Core Lab Services

• Ultrasound: VasCore has proven expertise in the use of duplex ultrasonography in all peripheral vascular beds and applications spanning over two decades. We have extensive experience across a wide variety of devices and applications. Examples of information that can be drawn from duplex ultrasonography includes (but is not limited to) luminal narrowing/stenosis/occlusion, presence of plaque and foreign bodies, device morphology, flow volume analysis, thrombus location and analysis, etc.

• Wound: The VasCore Wound Core Laboratory offers dedicated Wound Core services to supplement clinical, pharmaceutical and device trials, under the leadership of vascular surgeon, Anahita Dua, MD. MSC, who also serves as Medical Director of the Mass General Vascular Lab and Associate Director of the Mass General Wound Center. VasCore offers state-of-the-art wound core lab services that implement validated and calibrated image analysis combined with clinical expertise in wound assessment. VasCore boasts a vast experience in many types of relevant trials, including therapies for critical limb ischemia and non-healing ulcers. VasCore’s trial expertise, when coupled with its rich experience in domestic and international regulatory policies, generate value for VasCore’s clients at each stage of product study and development

• Intravascular Ultrasound & Angiography: The VasCore Intravascular ultrasound and angiography core lab offers imaging analysis services to supplement clinical, pharmaceutical and device trials. Under the leadership of Kei Yamada, MD of the Mass General Interventional Radiology Department, VascCore provides sophisticated vascular core lab services that implement validated and calibrated image analysis and combines it with clinical and technical expertise in vascular interventions. With vast experience in many types of relevant trials including therapies for venous compression and thromboembolic disease, VascCore is in the forefront of intravascular ultrasound and angiography core-laboratory services. VasCore’s trial expertise combined with its experience in domestic and international regulatory requirements, generate value for VasCore’s clients at each stage of product study and development

• X-ray: VasCore offers the analysis of stent and device fracture and migration through the use of X-ray analysis. Services include protocol development regarding X-ray acquisition as well as image analysis

Sample Devices We Have Evaluated

• Percutaneous transluminal angioplasty balloon catheters
• Drug-coated balloon catheters
• Bare metal stents
• Drug-eluting stents
• Fabric-coated stents
• Dialysis access grafts/fistulae
• Bioresorbable stents
• Atherectomy devices
• Thrombectomy devices
• Percutaneous venous valves
• Endoluminal aortic stent-grafts
• Endovascular brachytherapy catheters

VasCore Trial Types

• First in human trials
• Single center observational studies
• Multi-center prospective registries
• Multi-center prospective randomized trials
• Post-approval studies and registries
• Investigator Initiated Trials

Examples of Pharmaceutical Studies in Which We Have Participated

• Medical therapies for peripheral artery disease
• Brachial artery reactivity
• Novel methods of drug delivery
• Carotid intima-media thickness

Examples of Vascular Beds Which We Have Assessed

• Superficial and deep venous systems
• Carotid artery
• Aorta
• Renal artery
• Iliac artery
• Superficial femoral artery
• Popliteal artery
• Infrapopliteal arteries
• Dialysis access

VasCore Collaborations

• Commercial medical technology companies
• Researchers and physicians from around the world
• National Institutes of Health

Countries Where We Work

• Argentina
• Australia
• Canada
• Chile
• China
• Columbia
• Eastern and Western Europe
• India
• Israel
• Japan
• New Zealand
• South Korea
• United States

Our Team

Our team consists of fully certified physicians, technologists and nurses, along with quality officers with a vast knowledge of regulatory guidelines—all committed to navigating you to a successful approval. Our highly experienced and consistent team will ensure smooth, efficient and accurate evaluations.

Some Clients We Have Worked With

VasCore provides guidance from start to finish for clients from New England to New Zealand.

Sample Publications

Sample publications by our team, that resulted from VasCore collaborations.