About Me
Qualifications
Medical Device Pathology
Medical Device Pathology
DVM
Dr. med. vet.
Diplomate, American College of Veterinary Pathologiy (Anatomical)
Almost 3 decades
of academic and corporate experience
in preclinical research
Multiple large animal species
Multiple implant locations:
heart, blood vessels, brain, lungs, liver, kidneys, nerves, muscles, subcutis
Routine approaches (ISO10993-6) for surrogate
DVM
Dr. med. vet.
Diplomate, American College of Veterinary Pathologiy (Anatomical)
Almost 3 decades
of academic and corporate experience
in preclinical research
Multiple large animal species
Multiple implant locations:
heart, blood vessels, brain, lungs, liver, kidneys, nerves, muscles, subcutis
Routine approaches (ISO10993-6) for surrogate sites, but also orthotopic locations and novel approaches during the prosection and histopathological analysis of biomaterials and/or devices.
Medical Device Pathology
Medical Device Pathology
Medical Device Pathology
A device pathologist is foremost a "visualization expert"..
Clear, uncluttered, transparent reporting.
Helping to put safe and efficient products into patients
Actively listening to understand the device, envisioning possible issues and contemplating real concerns.
Striving to respond and deliver in a timely manner.
Offering a direct line of
A device pathologist is foremost a "visualization expert"..
Clear, uncluttered, transparent reporting.
Helping to put safe and efficient products into patients
Actively listening to understand the device, envisioning possible issues and contemplating real concerns.
Striving to respond and deliver in a timely manner.
Offering a direct line of communication.
Working together as a Team to make the best decisions for a fast and robust path forward.
Relevant Publications
Medical Device Pathology
Relevant Publications
Kirchhof N: What Is "Preclinical Device Pathology": An Introduction of the Unfamiliar. Toxicol Pathol. (3): 205-212. 2019.
Hering BJ et al: Prolonged diabetes reversal after intraportal xenotransplantation of wild-type porcine islets in immunosuppressed nonhuman primates. Nature Medicine 12:301-303, 2006.
Hong J et al:Cardiac ablation via e
Kirchhof N: What Is "Preclinical Device Pathology": An Introduction of the Unfamiliar. Toxicol Pathol. (3): 205-212. 2019.
Hering BJ et al: Prolonged diabetes reversal after intraportal xenotransplantation of wild-type porcine islets in immunosuppressed nonhuman primates. Nature Medicine 12:301-303, 2006.
Hong J et al:Cardiac ablation via electroporation. Conf Proc IEEE Eng Med Biol Soc. 2009.
Gallegos RP et al: Transmural atrial fibrosis after epicardial and endocardial argon-powered CryoMaze ablation. J Card Surg 26:240-243, 2011.
Haines DE et al: Microembolism and catheter ablation II: effects of cerebral microemboli injection in a canine model. Circ Arrhythm Electrophysiol. 6:23-30, 2013.
Yang Z et al: Effect of Steroid Elution on Electrical Performance and Tissue Responses in Quadripolar Left Ventricular Cardiac Vein Leads. Pacing Clin Electrophysiol. 38(8):966-72, 2015.
Hocini M et al: Predictability of lesion durability for AF ablation using phased radiofrequency: Power, temperature, and duration impact creation of transmural lesions. Heart Rhythm. 13: 1521-6, 2016.
Adler S et al: Two-year extractability of novel left ventricular, active fixation leads in the sheep model. Pacing Clin Electrophysiol. 40(11):1291-1297, 2017.
Griffin DJ: Comparison of a Saline-coupled Bipolar Sealer Versus Traditional Electrosurgery in a Porcine Model of Chronic Wound Healing. Wounds 29(12):374-379, 2017.
Su W et al: Dosing of the second-generation cryoballoon using acute time-to-pulmonary vein isolation as an indicator of durable ablation in a canine model. J Interv Card Electrophysiol. 53(3):293-300. 2018.
Stewart MT et al: Intracardiac pulsed field ablation: Proof of feasibility in a chronic porcine model. Heart Rhythm. 16(5):754-764. 2019.
Stewart MT et al: Safety and chronic lesion characterization of pulsed field ablation in a Porcine model. J Cardiovasc Electrophysiol. 32(4):958-969. 2021
Meyerholtz DK, Burrough ER, Kirchhof N, Anderson DJ, Helke KL: Swine models in translational research and medicine. Manuscript submitted to Vet Path.