Histology

We provide the following routine histology services: Grossing, Tissue Processing to include dehydration, clearing, and infiltration into Paraffin and Plastic Embedding & Sectioning, and H&E Staining.  We also offer Frozen Sectioning including non-decalcified tissues and Cell Pellet Embedding & Sectioning.

In addition, we produce the following special stains which are utilized to identify the existence of certain amyloids, bacteria, chemicals, and minerals to aid in the diagnosis of diseased tissue.

· Alcian Blue
· Alizarin Red
· Congo Red
· Gram Stain
· Elastic van Geison
· Luxol Fast Blue
· Masson Trichrome
· Movat Pentachrome
· Miller’s trichrome
· Oil Red O
· Periodic Acid Schiff (PAS)
· Perl’s Prussian Blue
· Safranin O
· Sirius Red
· Sulphated Alcian Blue
· Toluidine Blue
· Von Kossa
· X-Gal

Diagnostic

Our CAP-accredited and CLIA-approved laboratory can help you meet your diagnostic and clinical research trial pathology needs. We offer diagnostic services for autopsy and surgical human specimens. Our analysis includes:

• Heart tissue: postmortem and explant gross & microscopic evaluation
• Endomyocardial: biopsy, myocardial tissue/resection (including tumors)
  Pericardial biopsy/resection, native/prosthetic heart valves
• Vascular specimens: aorta and its branches, coronary, temporal, carotid, etc.
  Full review of cardiovascular slides and blocks
• Cardiac devices: stents, stent-grafts, mechanical and bioprosthetic valves, prosthetic valve rings, pericardial devices, pacemakers, ventricular assist devices, and others
• Congenital heart disease devices: occluders, coils, glue, etc.

For more information regarding obtaining a pathology diagnostic consult, please send your request to info@cvpath.org to obtain a consultation request form.

Preclinical Trials

Through vast expertise in preclinical models and human disease, our research team offers study design consultation and small-scale device testing in vascular restenosis models from feasibility through GLP compliant regulatory submission. In-house preclinical models include small animals, such as rabbits and swine coronary & peripheral models, with acute and chronic study capabilities. Our services include biocompatibility and safety in addition to pharmacokinetic testing for the drug component. Whether your company is a startup or an established industry leader, CVPath is uniquely qualified to support the success of your device design.

Trial Design, Development, and Support

CVPath Institute partners with the medical technology industry on device design and evaluation. This partnership begins as early as the bench-level prototyping phase to preclinical research models with CVPath Institute addressing critical questions of feasibility, biocompatibility, and GLP safety.

Based on our deep expertise in human disease and superior scientific inquiry methods, we can assist our industry partners with developing preclinical research plans and regulatory consultation for investigational device 510K and IDE approvals. Our industry partners have embraced this consultation service given the current uncertain regulatory environment for medical device commercial approval.

In providing trial design, development, and support services, CVPath Institute manages study integrity, compliance, and oversees data integrity & final reports as part of our Quality Assurance (QA) program. Our QA program follows FDA Good Laboratory Practice (GLP) Regulations for Nonclinical Laboratory Studies.

Devices

CVPath Institute has experience with a broad range of medical devices in the clinical arena from cerebral to below-the-knee technologies, truly encompassing the entire anatomical cardiovascular territory.

Cerebral:

• Aneurysm repair and prevention devices such as coils, foams, hydrogels, and bioglues.
• Ischemic stroke intervention devices

Carotid:

• Nitinol stents
• Endarterectomy Samples

Aorta:

• Grafts
• Stent grafts

Heart:

• Valves:
  • Aortic: TAVI, prosthetic and mechanical, surgical valves
  • Mitral: artificial chordae, leaflet augmentation, various types of annuloplasty rings, leaflet resection, edge to edge repair, coronary sinus annuloplasty, annular modification, percutaneous mitral valve repair, chamber remodeling, ultrasound technologies, and mitral cerclage
• Myocardium: atrial septal defect (PFO occluders), atrial appendage occluders, right and left ventricular assist devices, cell therapy, pacing leads, balloon         ablation for atrial fibrillation
• Coronary arteries: stents (bare metal, drug-eluting, bioerodible scaffolds), drug-coated balloons

Renal

• Sympathetic nerve ablation

Non-vascular stents

• Liver
• Biliary

Iliac, SFA, below the knee

• Plaque excision
• Peripheral stents: nitinol, bioerodible scaffolds, stent grafts. drug-coated balloons
• Vascular access closure devices

Hemodialysis

• AV Shunt
• Stents

Clinical

Our CAP-accredited and CLIA-approved laboratory can help you meet the pathology requirements of your clinical trials. We offer diagnostic services for autopsy and surgical specimens associated with the cardiovasculature as well as other related organ systems. Our extensive experience with the interaction and impact of emerging interventional technologies on human tissues will ensure that your clinical research trial pathology needs are well supported.

CVPath provides pathology support for clinical trials involving:

• Cardiovascular toxicity
• Medical devices
• Stents: coronary, peripheral, carotid
• Grafts
• Valves: TAVI
• Heart failure
• Tissue examination and analysis
• Whole heart grossing
• Excised atherosclerotic plaque
• SilverHawk
• Carotid endarterectomy
• Thrombectomy material
• Distal filter material [embolic protection]
• Surgically resected aneurysms
• Endomyocardial biopsies

Imaging

The CVPath Insitute offers an established resource for ex-vivo and in-vivo intravascular imaging tools including intravascular ultrasound, optical coherence tomography, angioscopy, near-infrared spectroscopy, etc. and helps develop new or improve existing modalities by offering a wide range of coregistration services between histology and invasive/non-invasive imaging modalities.

Optical Coherence Tomography Analysis – We offer our clients expert guidance on intravascular image acquisition using OCT and OFDI technology and provide state-of-the-art imaging analysis including comprehensive OCT core laboratory analysis.

Micro-CT – nondestructive micron-level 3D imaging for clinical samples, tissue, and devices

Our custom-built Nikon XT H 225ST Microfocus Computed Tomography scanner, paired with the powerful rendering suite VGStudio MAX 3.0 and expert imaging staff, allows us to examine clinical samples, tissue, and devices with never before seen precision and clarity for nondestructive imaging.

With the ability to scan objects from under 1 cubic millimeter to over 50 centimeters, the Micro-CT stands alone as the best method for imaging delicate samples without destroying them. Voxel-based measurement and analysis through VGStudio mean that not only can we produce visually stunning images, but we can make measurements in any plane of any device and perform volumetric measurements on calcification. Images can be produced in a variety of formats, including but not limited to: 3D virtual dissection movies, 3D STL files, 2D virtual histology, 2D image slice movies, and DICOM sets. The Micro-CT also serves as a powerful addition to any study involving analysis of histologic sections by providing technicians with the exact locations of regions of interest so that only the best data is put forth in the slides we produce.

Aloke Finn, MD

Other Affiliations:

Associate Clinical Professor of Medicine
University of Maryland at Baltimore

I am a physician-scientist whose focus is on the pathology of cardiovascular disease and its treatment.  I serve as the Medical Director and Chief Scientific Officer for CVPath Institute where I am involved in overseeing device development research and run a molecular lab with focus on the molecular understanding of vascular wall injury and healing, genetics of sudden cardiac death and molecular basis of coronary artery disease.  When not running CVPath, I perform interventional cardiology procedures at University of Maryland weekly.

Awards and Honors:

DeSanctis Clinical Scholar, Harvard Medical School, 2003-2004; Thomas Linnemeier Young Investigator Award Finalist, Columbia University/ Cardiovascular Research Foundation, 2006; Outstanding Scientific Citation (Basic Research-Early Career), Emory Department of Medicine, 2010; Finalist Irvine H. Page Award, American Heart; Member Emory Millipub Club (paper authorship with >1000 citations), 2013; Basic Science Publication of the Year University of Maryland Department of Medicine, 2018

Renu Virmani, MD FACC

Dr. Virmani is an internationally renowned cardiovascular pathologist. She is recognized as a leading researcher in the field of cardiovascular disease treatments.

Dr. Virmani serves as the President of CVPath Institute, which she founded in 2005. Dr. Virmani lectures at scientific meetings, both nationally and internationally, and has delivered more than 800 presentations globally. She is responsible for multiple research grants in the field of cardiovascular pathology and has authored or co-authored over 600 publications in peer-reviewed journals in the field of atherosclerosis, vulnerable plaque, stents, and other cardiovascular diseases. She has edited 7 books and written over 100 book chapters. Dr. Virmani is also reviews manuscripts for many scientific journals.

Dr. Virmani was presented with the 2012 TCT Career Achievement Award by the Cardiovascular Research Foundation. She has been recognized by the Council on Clinical Cardiology of the American Heart Association and also delivered the Laennec Clinician Educator Lecture in 2010. She was awarded an honorary degree from the University of Antwerp, Belgium in 2008 and has also received honorary awards from European Society of Cardiology (2008) and EuroPCR (2006).

Dr. Virmani served as Chairperson at the Department of Cardiovascular Pathology of the Armed Forces Institute of Pathology from 1984 until 2004. Dr. Virmani is a member of the American Heart Association, the U.S. and Canadian Academy of Pathology, and is a Fellow of the American College of Cardiology

Awards and Honors:

Joint Service Commendation Medal for Outstanding Meritorious Service as Chief, Division of Cardiovascular Research, Armed Forces Institute of Pathology, Washington, D.C. for the period of 5 July 1979 through 4 August 1981

Gold Medal for Best Scientific Exhibit at the American Society of Clinical Pathologists, Las Vegas, Nevada, October 1981

Silver Medal for Second Best Scientific Exhibit at the American Society of Clinical Pathologists, Las Vegas, Nevada, October 1985

Edward Rhodes Stitt Lecture Award, Association of Military Surgeons of the United States, San Antonio, Texas, November 1988

Member Cardiology Advisory Committee, national Heart, Lung, and Blood Institute, National Institute of Health, Bethesda, Maryland, October 1988 to March 1992

Member AIDS Advisory Committee, National Heart, Lung, and Blood Institute, National Institutes of Health, October 1989 to Sept 1993.

Member judging panel for the 1996 Young Investigators Awards Competition in the Physiology, Pharmacology & Pathology Category. 45th Annual Scientific Session of the College of Cardiology, Orlando, Florida.

2006 – Ethica Award, EuroPCR, Paris, France, May 2006.

2007 – Society for Cardiovascular Pathology Distinguished Achievement Award,  March 25, 2007.

2008 – Doctor Honoris Causa, Universiteit Antwerpen, Hoogleraar Cardiovaculaire Pathologie aan de George Washington Universiteit, Washington, DC, Antwerpen, Belgium, May 6, 2008.

2010 – Laennec Clinician/Educator Lecture Award from the American Heart Association, November 15, 2010.

2011 – BAS Hugh Sinclair Lecture, British Atherosclerosis Society

Manchester, England, June 13, 2011.

2012 – Simon Dack Award from JACC Journals.  March 25, 2012

2012 – RT Hall Lecture Award from International Faculty for CSANZ 2012 Brisbane.  August 17, 2012.

2012 – TCT Career Achievement Award from the Cardiovascular Research Foundation.  October 25, 2012.

2013 – ICI 2013 Award (Innovations in Cardiovascular Interventions Award), Tel Aviv, Israel, December 2013.

2014  – Houston Methodist Leading Medicine Award from Houston Methodist Research Institute, October 9-10, 2014.

2014 – Beacon of Interventional Cardiology Award from India Live 2015, Chennai, India, February 26-27, 2015

2015 – TCT Career Achievement Award, CADECI 2015, Guadalajara, Jalisco (Mexico), February 11-12, 2015.

Frank D. Kolodgie, PhD

Dr. Kolodgie’s primary research interest is in arteriosclerosis/heart failure.  Since its founding in 2005, Dr. Kolodgie has served as the Associate Director of CVPath Institute. Dr. Kolodgie’s over thirty-year span of research has focused on the pathology of human vascular disease, including the role of inflammation, apoptosis, and neoangiogenesis in the progression of atherosclerosis in addition to translational research in the interventional device field.  Dr. Kolodgie has been the recipient of over 10 research grants and has authored and co-authored over 160 scientific publications in peer-reviewed journals and more than 30 book chapters.

Awards and Honors:

Young Investigator, American College of Cardiology, Annual Scientific Session, 1995

Maria E. Romero, MD FCAP

Dr. Romero joined CVPath as a Staff Pathologist in 2014. Dr. Romero is board certified in Anatomic Pathology and Cytopathology. She received her medical degree from San Marcos University School of Medicine in Lima, Peru. Dr. Romero completed her residency training in Anatomic Pathology at Georgetown University Hospital in Washington DC followed by a cytopathology fellowship at the Virginia Commonwealth University Hospital in Richmond, VA. She completed a post-doctoral fellow at the Ultra-structural Pathology section at the National Cancer Institute (NCI), Bethesda, MD.  Dr. Romero’s clinical and research interests are focused on the diagnosis and mechanisms of atherosclerosis, preclinical safety, and the effectiveness of neuroprotection devices and valvular pathology. She is a member of the United States and Canadian Academy of Pathology (USCAP), College of American Pathologist (CAP) and the Society of Cardiovascular Pathology (SCVP).

Awards and Honors:

Fellow’s Award for Research Excellence (FARE), National Cancer Institute

Saikat Kumar B. Ghosh PhD

Dr. Ghosh joined CVPath as a Senior Research Scientist in January 2021. He received his Doctoral degree from Pennsylvania State University in 2011. He completed two postdoctoral fellowships, the first at Penn State designing a study to characterize the intricacies of protein-RNA interactions regulating gene expression in human cells. In his second fellowship at the University of MD, Baltimore School of Medicine he studied proteins that regulate intimal hyperplasia. Prior to joining UMD Baltimore, Dr. Ghosh worked at the US Department of Agriculture. His research was aimed at developing molecular biopesticides against invasive insect pests. He is an inventor on several patents that use RNAi mediated gene silencing and dsRNA delivery methods to reduce insect pests of global importance. Dr. Ghosh will be directing the Molecular and Genomic Research Laboratory where research areas will focus on atherosclerosis, coronary artery disease, macrophage inflammation and angiogenesis, genetics of sudden cardiac death, endothelial dysfunctions, and lipoprotein metabolism.

1990's-2000

1990’s – Intravascular Brachytherapy – Virmani predicts that intravascular brachytherapy for the treatment of coronary disease “will not work”.

1995 – Defined Plaque Erosion – Farb, Virmani, and colleagues describe a second significant cause of acute coronary thrombosis.

1997 – Identify Entity of Thin-cap Fibroatheroma (TCFA) – Burke, Virmani and colleagues develop a working definition of lesion vulnerability based on fibrous cap thickness and address predisposing risk factors to high-risk plaque.

2000 – Natural History of Atherosclerosis – Virmani, and colleagues introduce a modification to the American Heart Association Consensus Classification based on their experience with lesion morphology in sudden coronary death.

2001 – Further Define Thin-cap Fibroatheroma (TCFA) – Kolodgie, Virmani, and colleagues further explain the pathologic entity of the thin-cap fibroatheroma (TCFA) in relation to morphology, incidence and location.

2000's - 2015

2003 – Significance of Intraplaque Hemorrhage – Kolodgie, Virmani, and colleagues identify erythrocyte-derived cholesterol resulting from intraplaque neoangiogenesis and hemorrhage as a mechanism of necrotic core expansion and lesion vulnerability.

2004 – Late In-stent Thrombosis – Virmani and colleagues first describe the pathology of late-stent thrombosis attributed to drug-eluting stents.

2004 – Hypersensitivity and Late Stent Thrombosis – A severe localized hypersensitivity reaction consisting of predominantly T lymphocytes and eosinophils may have caused late stent thrombosis.

2010 – Neoatherosclerosis in Stents – Virmani, and colleagues are first to describe the pathology of neoatherosclerosis in drug-eluting and bare-metal stents.

2012 – Endothelium in Atherothrombosis and coronary stenting – Virmani and colleagues discovered that maintenance of a competently functioning endothelium is critical for long-term vascular health.

2013 – 2nd Generation Drug-eluting Stent – CVPath researchers discovered CoCr-EES demonstrated great strut coverage with less inflammation, less fibrin deposition, and less late and very late stent thrombosis.

2015 – Renal Sympathetic Denervation for Hypertension – the CVPath research team discovered that transcatheter ablation of renal autonomic nerves is a viable option for the treatment of resistant arterial hypertension.

2016 -

2016 – Thrombogenicity in Biodegradable Polymer Stents – Contemporary Drug-Eluting Stents with Biodegradable Polymer Coatings Assessed ExVivo in a swine shunt model.

2017 – Pathology of Transcatheter Aortic Valves – First systemic macroscopic pathologic analysis of self-expanding transcatheter aortic valves.

2018 – CD163 Macrophages in Atherosclerosis – Alternative macrophages promote plaque angiogenesis, leakiness, inflammation, and progression. 

2019 – Histopathologic characteristics of PAD – We demonstrated detailed histopathologic characteristics of peripheral arteries in patents with abundant risk factors.