We help you so you can help others.

It can be a long road from the invention of a vascular device to regulatory approval.

Whether it’s determining the type of trials needed to evaluate your product, to accurately analyzing its efficacy, to knowing the best way to present it to regulatory agencies, the process can be overwhelming. That’s why VasCore is committed to helping clients worldwide navigate the process, every step of the way. For more than a decade, VasCore has been considered the leader in the strategic development of imaging protocols and the interpretation of ultrasound and radiographic images as part of novel vascular device trials. Every day, we help turn the challenges of approval into successes for effective vascular products.

About

Meet our dedicated team of experts.

Having a full-time, highly-experienced and consistent staff who aren’t constantly shifting roles allows us to ensure smooth, efficient and accurate evaluations. 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.

Quality/Consistency/Reliability
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.

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Expertise

An industry leader. And your leader through the approval process.

Few core labs offer the high level of expertise and thorough, friendly customer service as does VasCore. Maybe that’s why we’re considered the leader in everything from the development of multicenter vascular device imaging protocols, to the analysis of ultrasound and radiographic images, to the reporting of data to sponsors and regulatory groups across the globe.

The VasCore Innovation Strategies

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First Iliac Artery Stent Approved in the U.S.

Challenge

A sponsor wants to design a clinical trial to result in approval of their iliac artery stent by the US Food and Drug Administration.

Solution

We designed the duplex ultrasound imaging protocol and trained the sites in the performance of this imaging protocol.

Result

First Iliac Artery Stent Approved in the U.S.

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Services

We offer a wide range of services, for a smooth road to approval.

For more than 15 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.

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Clients

Guidance from start to finish for clients from New England to New Zealand.

480 Biomedical Abbot: A Promise for Life BARD Biotronik Boston Scientific Cardiosonic CSI Cardiva Medical, Inc Cook Medical Cordis: a Johnson + Johnson company Covidien CVIngenuity Flexible Stenting Solutions Getinge Group IDEV Intact Vascular Medrad Medtronic Otsuka Pervasis Proteon Silkroad Medical Spectranetics Terumo Theravasc Vessix Vascular
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Publications

Read about our work.

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IN.PACT AV Access Investigators. Drug-Coated Balloons for Dysfunctional Dialysis Arteriovenous Fistulas

2020 Aug 20;383(8):733-742

The New England Journal of Medicine

Lookstein RA, Haruguchi H, Ouriel K, Weinberg I, Lei L, Cihlar S, Holden A.

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Contact

Turn the challenges of approval into successes.

Location

One Bowdoin Square
10th Floor
Boston, MA 02114

Map

Phone
& Fax

P / 617.726.5552 F / 617.726.1977