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Medtronic receives US FDA Breakthrough Device designation for IN.PACT BTK drug-coated balloon. 30th September 2026 Medtronic has received US Food and Drug Administration (FDA) Breakthrough Device designation for its IN.PACT below-the-knee (BTK) drug-coated balloon. While drug-coated balloons transformed treatment above the knee, physicians treating chronic limb-threatening ischemia (CLTI) below the knee are still working with a standard of care that often falls short, describes the company in a recent press release. Currently, Medtronic is planning IN.PACT BTK DELTA, a global, randomised pivotal trial enrolling approximately 400 patients with BTK lesions. According to the company, this is a notable trial in regards to scale for the investigation of BTK peripheral arterial disease (PAD), designed to generate the kind of evidence-based data this field has been missing. The company is set to present the technology at the upcoming 2026 Vascular InterVentional Advances (VIVA; 4-7 October, Las Vegas, USA) conference. On October 6, Eric A Secemsky, principal investigator and interventional cardiologist at Beth Israel Deaconess Medical Center in Boston, USA, will present on the IN.PACT BTK drug-coated balloon during 'Red Horizons: The VIVA Innovation Summit'.

Welcome new pathology faculty! The Department of Pathology is pleased to welcome our outstanding new faculty members who will further strengthen our already outstanding team. Together our faculty community - both longstanding and new - will continue to advance our mission to deliver high-quality diagnostics, drive impactful research, and train the next generation of pathologists. We are delighted to introduce our newest colleagues and look forward to the many contributions they will make to our department and broader academic community. Adriano Piris, MD, is an expert dermatopathologist with extensive experience in the academic and private sectors. He joins the dermatopathology group where he will sign out routine cases, intramural and extramural consults, and will actively participate in the academic and teaching activities within the department. He is a graduate from the Medical School of the Universidad Nacional de Asuncion in Paraguay. He completed postgraduate training at Berkshire Medical Center and Massachusetts General Hospital (MGH Anatomic Pathology), and BIDMC (Dermatopathology). He is a former Assistant Professor in Dermatology at Harvard Medical School and former Director of the Mihm Cutaneous Pathology Consultative Service at Brigham Dermatology. He is currently a senior dermatopathology consultant for Sonic Health Care USA. He has worked with the Melanoma Group of the National Cancer Institute in Milan, Italy. Most recently, in collaboration with the Mohs micrographic surgery unit at Brigham and Women's Dermatology, he developed the first and only scoring system for desmoplasia in cutaneous squamous cell carcinoma, a work recently published in the Journal of Investigative Dermatology. Elena Brachtel, MD, PhD, is an internationally recognized breast pathologist and cytopathologist with extensive experience in academic medicine, clinical practice, research, and education. Dr. Brachtel will be stepping into the role of Co-Director, Breast Pathology. She joins us from the University of Miami Miller School of Medicine and has previously held faculty appointments at Massachusetts General Hospital and Harvard Medical School. Her clinical and research interests focus on breast pathology, breast cancer diagnostics, cytopathology, biomarker testing, and emerging technologies in cancer diagnosis. Throughout her career, Dr. Brachtel has made significant contributions to advancing breast cancer pathology, authored numerous peer-reviewed publications, and served in leadership roles in fellowship training and subspecialty pathology services. She is widely recognized for her commitment to trainee education, multidisciplinary collaboration, and innovation in diagnostic pathology. We look forward to her contributions to our clinical, educational, and research missions. Xia Qian, MD, joins our Dermatopathology team. She completed her AP/CP Residency and Dermatopathology Fellowship at BIDMC. She earned both her MD and PhD from Nanjing Medical University in Nanjing, China. She brings an extensive background in both clinical pathology and translational research, with prior work spanning cancer biology, liver disease, and gastrointestinal pathology. Her current research focuses on melanoma and inflammatory skin diseases, including the clinicopathologic features of mucosal melanoma and cutaneous syphilis. Maxwell Roth, MD, joins the Division of Laboratory and Transfusion Medicine as Assistant Director of the Blood Bank and Director of Transfusion Informatics. He received his MD from Albert Einstein College of Medicine and completed his residency in AP/CP at Massachusetts General Hospital. He subsequently completed a fellowship in Blood Banking/Transfusion Medicine at Mass General Brigham. His research focuses on informatics-based approaches to investigate transfusion medicine practices and outcomes in critically ill patients, as well as studying blood cell population dynamics. Before joining BIDMC, Xuefei Huang, MD, PhD, was an Assistant Professor of Pathology at UMass Chan Medical School with expertise in gastrointestinal, pancreatobiliary, liver, and liver transplant pathology. She began medical school at the age of 16 and earned an MD and PhD in China. Her doctoral research was among the first to demonstrate the therapeutic potential of Aurora kinase inhibition in acute myeloid leukemia, with the findings published in Blood. She was a postdoctoral fellow at MD Anderson Cancer Center and Boston Children's Hospital. She completed her AP/CP residency at UMass Chan Medical School, where she served as Chief Resident, followed by a fellowship in Gastrointestinal and Liver Pathology at Johns Hopkins Hospital. She has authored and co-authored numerous peer-reviewed publications in leading journals. Mai Elzieny, MD, joins the department as a faculty member in Anatomic Pathology, following a General Surgical Pathology fellowship at the David Geffen School of Medicine at UCLA and residency training in Anatomic and Clinical Pathology at Corewell Health William Beaumont University Hospital in Michigan. Dr. Elzieny earned her medical degree and master's degree in Clinical and Chemical Pathology from Ain Shams University Faculty of Medicine in Cairo, Egypt, where she also served as an Assistant Lecturer in Clinical Pathology. Her interests span surgical pathology, pathology education, quality improvement, and diagnostic innovation. She has contributed to a growing body of publications in areas including pathology informatics, artificial intelligence applications in pathology, laboratory medicine, and renal and liver pathology. Dr. Elzieny has also demonstrated a strong commitment to mentorship, diversity and inclusion initiatives, and trainee education throughout her career. Maxwell L. Harsha, PhD, DABCC, joins the Division of Clinical Laboratory Medicine as Assistant Director of Clinical Chemistry and Director of Diagnostic Endocrinology. Dr. Harsha comes to BIDMC from Johns Hopkins University School of Medicine, where he completed fellowship training in Clinical Chemistry and gained extensive experience in laboratory operations, clinical consultation, quality improvement, assay validation, and translational research. He earned his PhD in Environmental Analytical Chemistry from the University of New Orleans and his BS in Biochemistry from Loyola University Chicago. His research has spanned both analytical and clinical chemistry, with interests including diagnostic endocrinology, toxicology, therapeutic drug monitoring, and laboratory utilization. He has authored numerous peer-reviewed publications and presentations and has received several national trainee awards and recognitions. Sunati Sahoo, MD, joins the department as Director of Surgical Pathology, Co-Director of Breast Pathology, and Director, Specimen Biobank. Dr. Sahoo comes to BIDMC from UT Southwestern Medical Center where she was a Professor of Pathology. She led the breast pathology service and previously served as Director of Surgical Pathology at William P. Clements Jr. University Hospital. She earned her medical degree in India and completed postgraduate pathology training at the All India Institute of Medical Sciences in New Delhi, followed by residency training at New York-Presbyterian/Weill Cornell Medical Center. Dr. Sahoo's research has focused on neoadjuvant systemic therapy in breast cancer, prognostic and predictive biomarkers, and quality and outcomes research in breast disease management. Her arrival further strengthens BIDMC/HMFP Pathology's commitment to excellence in breast pathology, academic medicine, and multidisciplinary oncology care. Marina Vivero, MD, joins the department as a full-time attending pathologist in Anatomic Pathology, with subspecialty expertise in Thoracic Pathology and Cytopathology. Dr. Vivero comes to BIDMC from Brigham and Women's Hospital, where she served as an Associate Pathologist since 2015 and as an Assistant Professor of Pathology at Harvard Medical School since 2019. An internationally recognized expert in thoracic disease pathology and cytopathology, Dr. Vivero has made significant contributions to the diagnosis and classification of lung tumors, pulmonary neuroendocrine neoplasms, mesothelioma, and interstitial lung disease. Her research has helped advance the use of cytology specimens for molecular testing in lung cancer and has contributed to national and international diagnostic guidelines, including World Health Organization reporting systems and American Thoracic Society clinical guidance. In addition to her clinical and research accomplishments, Dr. Vivero has a longstanding commitment to education and mentorship. Kristine Wong, MD, joined Head and Neck and Cytopathology in early September. Widely recognized for her research, peer-reviewed publications, and lectures in thyroid pathology, endocrine pathology, head and neck pathology, and cytopathology, she joins us from BWH and is an Assistant Professor at Harvard Medical School. She attended Washington University School of Medicine and completed her AP/CP residency and Cytopathology fellowship at BWH. She is the co-author of the "Oncocytic Follicular Neoplasm" chapter of the Bethesda System for Reporting Thyroid Cytopathology, 3rd edition.

Beth Israel Deaconess plans new building in Needham as patient volume doubles