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 Boston Biomedical Associates, renowned leaders in quality oversight and assurance. BBA 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

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.

First Major Publication of Carotid Stent vs. Carotid Endarterectomy

Challenge

Carotid artery stenting comes on to the US scene, with the first multicenter high risk carotid stent protocol.

Solution

We develop a common duplex ultrasound protocol for this trial.

Result

First Major Publication of Carotid Stent vs Carotid Endarterectomy

Approval of Renal Artery Stent Based on Duplex Ultrasonography

Challenge

Renal artery duplex ultrasonography, one of the most challenging clinical examinations, is an ideal surveillance study for stents in clinical trials.

Solution

We run such a trial where duplex ultrasonography is the primary endpoint modality.

Result

Approval of Renal Artery Stent Based on Duplex Ultrasonography

The Accepted Definition of Stent Fracture Types

Challenge

Fractures of stents has become a significant concern for manufacturers, physicians, and regulatory groups.

Solution

We helped develop the appropriate methods to study and report stent fractures.

Result

The accepted definition of stent fracture types established

The First Positive Study of Drug Eluting Stents in the Superficial Femoral Arteries

Challenge

Drug eluting stents hold great potential for treatment of peripheral artery disease.

Solution

We developed and validated the process of ultrasound surveillance of endovascular stents in the superficial femoral artery.

Result

The First Positive Study of Drug Eluting Stents in the Superficial Femoral Arteries

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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.

Devices we’ve 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

Pharmaceutical studies in which we’ve participated:

  • Brachial artery reactivity
  • Novel methods of drug delivery
  • Carotid intima-media thickness

Vascular Beds in which we’ve been involved:

  • Carotid Artery
  • Aorta
  • Renal Artery
  • Iliac Artery
  • Superficial Femoral Artery
  • Popliteal Artery
  • Infrapopliteal Arteries
  • Superficial and deep venous systems

VasCore Collaborations:

  • Commercial medical technology companies
  • Researchers and physicians from around the world
  • National institutes of health

Countries where we work:

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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.

Lower extremity revascularization using directional atherectomy: 12-month prospective results of the DEFINITIVE LE study.

2014 Aug;7(8):923-33

JACC: Cardiovascular Interventions

McKinsey JF, Zeller T, Rocha-Singh KJ, Jaff MR, Garcia LA

Proper patient selection yields significant and sustained reduction in systolic blood pressure following renal artery stenting in patients with uncontrolled hypertension: long-term results from the HERCULES trial.

2014 Jul;16(7):497-503

The Journal of Clinical Hypertension

Chrysant GS, Bates MC, Sullivan TM, Bachinsky WB, Popma JJ, Peng L, Omran HL, Jaff MR

Application of human type I pancreatic elastase (PRT-201) to the venous anastomosis of arteriovenous grafts in patients with chronic kidney disease.

2014 May 3;0(0):0

The Journal of Vascular Access

Dwivedi AJ, Roy-Chaudhury P, Peden EK, Browne BJ, Ladenheim ED, Scavo VA, Gustafson PN, Wong MD, Magill M, Lindow F, Blair AT, Jaff MR, Franano FN, Burke SK

Nitinol stent implantation in the superficial femoral artery and proximal popliteal artery: twelve-month results from the complete SE multicenter trial.

2014 Apr;21(2):202-12

Journal of Endovascular Therapy

Laird JR, Jain A, Zeller T, Feldman R, Scheinert D, Popma JJ, Armstrong EJ, Jaff MR

Human type I pancreatic elastase treatment of arteriovenous fistulas in patients with chronic kidney disease.

2014 Aug;60(2):454-461.e1

Journal of Vascular Surgery

Hye RJ, Peden EK, O'Connor TP, Browne BJ, Dixon BS, Schanzer AS, Jensik SC, Dember LM, Jaff MR, Burke SK

Peripheral arterial calcification: prevalence, mechanism, detection, and clinical implications.

2014 May 1;83(6):E212-20

Catheterization and Cardiovascular Interventions

Rocha-Singh KJ, Zeller T, Jaff MR

Blood pressure response to renal artery stenting in 901 patients from five prospective multicenter FDA-approved trials.

2014 Mar 1;83(4):603-9

Catheterization and Cardiovascular Interventions

Weinberg I, Keyes MJ, Giri J, Rogers KR, Olin JW, White CJ, Jaff MR

Stenting and medical therapy for atherosclerotic renal-artery stenosis.

2014 Jan 2;370(1):13-22

New England Journal of Medicine

Cooper CJ1, Murphy TP, Cutlip DE, Jamerson K, Henrich W, Reid DM, Cohen DJ, Matsumoto AH, Steffes M, Jaff MR, Prince MR, Lewis EF, Tuttle KR, Shapiro JI,Rundback JH, Massaro JM, D'Agostino RB Sr, Dworkin LD

Sustained safety and effectiveness of paclitaxel-eluting stents for femoropopliteal lesions: 2-year follow-up from the Zilver PTX randomized and single-arm clinical studies.

2013 Jun 18;61(24):2417-27

Journal of the American College of Cardiology

Dake MD, Ansel GM, Jaff MR, Ohki T, Saxon RR, Smouse HB, Snyder SA, O'Leary EE, Tepe G, Scheinert D, Zeller T

Rationale and design of the ATTRACT Study: a multicenter randomized trial to evaluate pharmacomechanical catheter-directed thrombolysis for the prevention of postthrombotic syndrome in patients with proximal deep vein thrombosis.

2013 Apr;165(4):523-530.e3

American Heart Journal

Vedantham S1, Goldhaber SZ, Kahn SR, Julian J, Magnuson E, Jaff MR, Murphy TP, Cohen DJ, Comerota AJ, Gornik HL, Razavi MK, Lewis L, Kearon C

Zotarolimus-eluting peripheral stents for the treatment of erectile dysfunction in subjects with suboptimal response to phosphodiesterase-5 inhibitors.

2012 Dec 25;60(25):2618-27

Journal of the American College of Cardiology

Rogers JH, Goldstein I, Kandzari DE, Köhler TS, Stinis CT, Wagner PJ, Popma JJ, Jaff MR, Rocha-Singh KJ

Excimer laser with adjunctive balloon angioplasty and heparin coated self expanding stent grafts for the treatment of femoropopliteal artery in-stent restenosis: twelve month results from the SALVAGE trial.

2012; Mar 15

Catheterization and Cardiovascular Interventions

Laird JR, Yeo KK, Rocha-Singh K, Das T, Joye J, Dippel E, Reddy B, Botti C, Jaff MR

Significant reduction in systolic blood pressure following renal artery stenting in patients with uncontrolled hypertension: results from the HERCULES trial.

2012

Catheterization and Cardiovascular Interventions

Jaff MR, Bates M, Sullivan T, Popma JJ, Gao X, Zaugg M, Verta P

Nitinol stent implantation vs balloon angioplasty for lesions in the superficial femoral and proximal popliteal arteries of patients with claudication: three year follow up of the randomized RESILIENT trial.

2012;19:1-9

Journal of Endovascular Therapy

Laird JR, Katzen BT, Scheinert D, Lammer J, Carpenter J, Buchbinder M, Dave R, Ansel G, Lansky A, Cristea E, Collins TJ, Goldstein J, Cao AY, Jaff MR.

Supervised exercise versus primary stenting for claudication resulting from aortoiliac peripheral artery disease: six-month outcomes from the Claudication: Exercise Versus Endoluminal Revascularization (CLEVER) Trial.

2012;125:130-9

Circulation: Cardiovascular Interventions

Murphy TP, Cutlip DE, Regensteiner JG, Mohler ER, Cohen DJ, Reynolds MR, Massaro JM, Lewis BA, Cerezo J, Oldenberg NC, Thum CC, Goldberg S, Jaff MR, Steffes MW, Comerota AJ, Ehrman J, Treat-Jacobson D, Walsh ME, Collins T, Badenhop DT, Bronas U, Hirsch AT

Paclitaxel-eluting stents show superiority to balloon angioplasty and bare metal stents in femoropopliteal disease: 12-month Zilver PTX randomized study results.

2011;4:495-504

Circulation: Cardiovascular Interventions

Dake MD, Ansel GM, Jaff MR, Ohki T, Saxon RR, Smouse HB, Machan LS, Zeller T, Roubin GS, Burket MW, Khatib Y, Snyder SA, Ragheb AO, White JK

Two-year clinical evaluation of the Zilver vascular stent for symptomatic iliac peripheral artery disease.

2010;21:1489-94

Journal of Vascular and Interventional Radiology

Jaff MR, Katzen BT

Protected carotid stenting in high risk patients: results of the Spider Rx arm of the carotid revascularization with eV3 arterial technology evolution trial.

2010;23:491-8

Journal of Vascular and Interventional Radiology

Safian RD, Jaff MR, Bresnahan JF, Foster M, Bacharach JM, Yadav J, Joye J, Myla S, Kassab E, Mass JT, Ansel GM

Nitinol stent implantation versus balloon angioplasty for lesions in the superficial femoral artery and proximal popliteal artery. Twelve-month results from the RESILIENT randomized trial.

2010;3:276-76

Circulation: Cardiovascular Interventions

Laird JR, Katzen BT, Scheinert D, Lammer J, Carpenter J, Buchbinder M, Dave R, Ansel G, Lansky A, Cristea E, Collins TJ, Goldstein J, Jaff MR

Carotid artery revascularization with the NexStent and Filterwire EX/EZ: 3-year results from the CABERNET trial

2010;5:917-24

Eurointervention

Hopkins LN, Myla S, Grube E, Eles G, Dave R, Jaff MR, Allocco D

Safety and effectiveness of the Invatec MoMa proximal cerebral protection device during carotid artery stenting: results of the pivotal ARMOUR trial

2010;76:1-8

Catheterization and Cardiovascular Interventions

Ansel G, Hopkins LN, Jaff MR, Rubino P, Bacharach JM, Scheinert D, Myla S, Das T, Cremonesi A

Renal artery stenting with non-invasive duplex follow up: 3-year results from the RENAISSANCE renal stent trial

2008;72:853-62

Catheterization and Cardiovascular Interventions

Rocha-Singh K, Jaff MR, Kelley LE

Standardized evaluation and reporting of stent fractures in clinical trials of non-coronary devices

2006;13:701-710

Journal of Endovascular Therapy

Jaff MR, Dake MD, Popma JJ, Ansel G, Yoder T

Drug-eluting and bare Nitinol stents for the treatment of atherosclerotic lesions in the superficial femoral artery: long-term results from the SIROCCO trial.

2006;13:701-710

Journal of Endovascular Therapy

Duda SH, Bosiers M, Lammer J, Scheinert D, Zeller T, Oliva V, Tielbeek A, Anderson J, Wiesinger B, Tepe G, Lansky A, Jaff MR, Mudde C, Tielemans H, Beregi JP

The safety and efficacy of the Starclose Vascular Closure System: the duplex ultrasound substudy of the CLIP study.

2006;68:684-689

Catheterization and Cardiovascular Interventions

Jaff MR, Hadley G, Hermiller JB, Simonton C, Hinohara T, Cannon L, Reisman M, Braden G, Fletcher DR, Zapien M, Chou T, DiDonato K

Stent revascularization for the prevention of cardiovascular and renal events among patients with renal artery stenosis and systolic hypertension: Rationale and design of the CORAL trial.

2006;152:59-66

American Heart Journal

Cooper CJ, Murphy TP, Matsumoto A, Steffes M, Cohen DJ, Jaff MR, Kuntz R, Jamerson K, Reid D, Rosenfield KA, Rundback JH, D’Agostino R, Henrich W, Dworkin L

Protected carotid stenting in high-risk patients with severe carotid artery stenosis.

2006;47:2384-9

Journal of the American College of Cardiology

Safian RD, Bresnahan JF, Jaff MR, Foster M, Bacharach JM, Maini B, Turco M, Myla S, Eles G, Ansel GM

Cryoplasty for the treatment of femoropopliteal arterial disease: results of a prospective multicenter registry.

2005;16:1067-1073

Journal of Vascular and Interventional Radiology

Laird J, Jaff MR, Biamino G, McNamara T, Scheinert D, Zetterlund P, Moen E, Joye JD

Evaluation of the safety and efficacy of renal artery stenting after unsuccessful balloon angioplasty: The ASPIRE-2 Study.

2005 Sep 6;46(5):776-83

Journal of the American College of Cardiology

Rocha-Singh K, Jaff MR, Rosenfield K; ASPIRE-2 Trial Investigators

Protected carotid artery stenting vs endarterectomy in high-risk patients

2004 Oct 7;351(15):1493-501

New England Journal of Medicine

Yadav JS, Wholey MH, Kuntz RE, Fayad P, Katzen BT, Mishkel GJ, Bajwa TK, Whitlow P, Strickman NE, Jaff MR, Popma JJ, Snead DB, Firth BG, Ouriel K.

The Nitinol SMART Stent vs. Wallstent for Suboptimal Iliac Artery Angioplasty: The CRISP-US Trial Results.

2004 Sep;15(9):911-8

Journal of Vascular and Interventional Radiology

Ponec D, Jaff MR, Swischuk J, Feiring A, Laird J, Mehran M, Popma JJ, Donohoe D, Firth B, Keim E, Snead D.

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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