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.
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.
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.
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.
A sponsor wants to design a clinical trial to result in approval of their iliac artery stent by the US Food and Drug Administration.
We designed the duplex ultrasound imaging protocol and trained the sites in the performance of this imaging protocol.
First Iliac Artery Stent Approved in the U.S.
Carotid artery stenting comes on to the US scene, with the first multicenter high risk carotid stent protocol.
We develop a common duplex ultrasound protocol for this trial.
First Major Publication of Carotid Stent vs Carotid Endarterectomy
Renal artery duplex ultrasonography, one of the most challenging clinical examinations, is an ideal surveillance study for stents in clinical trials.
We run such a trial where duplex ultrasonography is the primary endpoint modality.
Approval of Renal Artery Stent Based on Duplex Ultrasonography
Fractures of stents has become a significant concern for manufacturers, physicians, and regulatory groups.
We helped develop the appropriate methods to study and report stent fractures.
The accepted definition of stent fracture types established
Drug eluting stents hold great potential for treatment of peripheral artery disease.
We developed and validated the process of ultrasound surveillance of endovascular stents in the superficial femoral artery.
The First Positive Study of Drug Eluting Stents in the Superficial Femoral Arteries
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.
McKinsey JF, Zeller T, Rocha-Singh KJ, Jaff MR, Garcia LA
Chrysant GS, Bates MC, Sullivan TM, Bachinsky WB, Popma JJ, Peng L, Omran HL, Jaff MR
2014 May 3;0(0):0
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
Laird JR, Jain A, Zeller T, Feldman R, Scheinert D, Popma JJ, Armstrong EJ, Jaff MR
Hye RJ, Peden EK, O'Connor TP, Browne BJ, Dixon BS, Schanzer AS, Jensik SC, Dember LM, Jaff MR, Burke SK
2014 May 1;83(6):E212-20
Rocha-Singh KJ, Zeller T, Jaff MR
2014 Mar 1;83(4):603-9
Weinberg I, Keyes MJ, Giri J, Rogers KR, Olin JW, White CJ, Jaff MR
2014 Jan 2;370(1):13-22
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
Geraghty PJ, Mewissen MW, Jaff MR, Ansel GM
2013 Jun 18;61(24):2417-27
Dake MD, Ansel GM, Jaff MR, Ohki T, Saxon RR, Smouse HB, Snyder SA, O'Leary EE, Tepe G, Scheinert D, Zeller T
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
2012 Dec 25;60(25):2618-27
Rogers JH, Goldstein I, Kandzari DE, Köhler TS, Stinis CT, Wagner PJ, Popma JJ, Jaff MR, Rocha-Singh KJ
2012; Mar 15
Laird JR, Yeo KK, Rocha-Singh K, Das T, Joye J, Dippel E, Reddy B, Botti C, Jaff MR
Jaff MR, Bates M, Sullivan T, Popma JJ, Gao X, Zaugg M, Verta P
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.
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
2011; Dec 8: epub ahead of print
Burke MN, Hermiller J, Jaff MR
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
Jaff MR, Katzen BT
Safian RD, Jaff MR, Bresnahan JF, Foster M, Bacharach JM, Yadav J, Joye J, Myla S, Kassab E, Mass JT, Ansel GM
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
Hopkins LN, Myla S, Grube E, Eles G, Dave R, Jaff MR, Allocco D
Ansel G, Hopkins LN, Jaff MR, Rubino P, Bacharach JM, Scheinert D, Myla S, Das T, Cremonesi A
Rocha-Singh K, Jaff MR, Kelley LE
Jaff MR, Dake MD, Popma JJ, Ansel G, Yoder T
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
Jaff MR, Hadley G, Hermiller JB, Simonton C, Hinohara T, Cannon L, Reisman M, Braden G, Fletcher DR, Zapien M, Chou T, DiDonato K
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
Safian RD, Bresnahan JF, Jaff MR, Foster M, Bacharach JM, Maini B, Turco M, Myla S, Eles G, Ansel GM
Laird J, Jaff MR, Biamino G, McNamara T, Scheinert D, Zetterlund P, Moen E, Joye JD
2005 Sep 6;46(5):776-83
Rocha-Singh K, Jaff MR, Rosenfield K; ASPIRE-2 Trial Investigators
2004 Oct 7;351(15):1493-501
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.
Ponec D, Jaff MR, Swischuk J, Feiring A, Laird J, Mehran M, Popma JJ, Donohoe D, Firth B, Keim E, Snead D.