Learn More About 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 services to supplement clinical, pharmaceutical and device trials. Under the leadership of Shinjita Das, MD, of the Mass General Dermatology Department, we offer state of the art wound core lab services that implement validated and calibrated image analysis combined with clinical expertise in wound assessment. With a vast experience in many types of relevant trials including therapies for critical limb ischemia and non-healing ulcers, we are at the forefront of wound core services
  • 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

Country map

  • 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.

Meet our team

Some Clients We Have Worked With

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

480 Biomedical Intact Vascular
Abbott InterVene
Ablative Solutions Medinol
Alucent Biomedical Medrad
Bard Medtronic
Biotronik Mercator MedSystems, Inc.
Boston Scientific Microvention
Cardio Flow Otsuka
Cardiosonic Pervasis
CSI Proteon Therapeutics
Cardiva Medical, Inc. Reflow Medical
Cook Medical  Shockwave
Cordis Silk Road Medical
Covidien Spectranetics
CV Ingenuity Surmodics, Inc.
Flexible Stenting Solutions Terumo
Getinge Group TheraVasc
GORE Vascular Graft Solutions, Inc.
IDEV Veryan
Innovein Medical Vessix Vascular

Sample Publications

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

View publications list