Requiem for a Scaffold
Authors: Sanket S. Dhruva, Jeptha P. Curtis
Journal: Annals of Internal Medicine (2017)

Editorials7 November 2017Requiem for a ScaffoldSanket S. Dhruva, MD and Jeptha P. Curtis, MDSanket S. Dhruva, MDFrom Yale University School of Medicine, New Haven, Connecticut. and Jeptha P. Curtis, MDFrom Yale University School of Medicine, New Haven, Connecticut.Author, Article, and Disclosure Informationhttps://doi.org/10.7326/M17-2522 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail On 8 September 2017, the medical device manufacturer Abbott announced that it would halt the sale of its Absorb GT1 bioresorbable vascular scaffold (BVS), citing low sales and unsustainable margins (1). At the time of the announcement, Absorb accounted for less than 1% of the overall market for coronary stents, and the company's move came on the heels of a series of setbacks for the BVS program. In March 2017, Abbott, working with European authorities, imposed restrictions on BVS use outside clinical trials and registries. In that same month, the U.S. Food and Drug Administration (FDA) issued a letter to ...References1. Lou N. Abbott nixes Absorb BVS sales worldwide—focus shifts to second-gen device development. Medpage Today/CRTonline.org. 2017 Sept 8. Accessed at www.medpagetoday.com/cardiology/pci/67797 on 19 September 2017. Google Scholar2. U.S. Food and Drug Administration. FDA investigating increased rate of major adverse cardiac events observed in patients receiving Abbott Vascular's Absorb GT1 bioresorbable vascular scaffold (BVS)—letter to health care providers. 2017. Accessed at www.fda.gov/MedicalDevices/Safety/LetterstoHealthCareProviders/ucm546808.htm on 19 September 2017. Google Scholar3. Masoudi FA, Ponirakis A, de Lemos JA, Jollis JG, Kremers M, Messenger JC, et al. Trends in U.S. cardiovascular care: 2016 report from 4 ACC national cardiovascular data registries. J Am Coll Cardiol. 2017;69:1427-1450. [PMID: 28025065] doi:10.1016/j.jacc.2016.12.005 CrossrefMedlineGoogle Scholar4. Popma JJ, Weiner B, Cowley MJ, Simonton C, McCormick D, Feldman T. FDA advisory panel on the safety and efficacy of drug-eluting stents: summary of findings and recommendations. J Interv Cardiol. 2007;20:425-46. [PMID: 18042048] CrossrefMedlineGoogle Scholar5. Testa L, Latib A, Montone RA, Colombo A, Bedogni F. Coronary bioresorbable vascular scaffold use in the treatment of coronary artery disease. Circ Cardiovasc Interv. 2016;9. [PMID: 27412870] doi:10.1161/CIRCINTERVENTIONS.116.003978 CrossrefMedlineGoogle Scholar6. U.S. Food and Drug Administration. Absorb GT1™ Bioresorbable Vascular Scaffold (BVS) System - P150023. 2016. Accessed at www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm509951.htm on 19 September 2017. Google Scholar7. Ellis SG, Kereiakes DJ, Metzger DC, Caputo RP, Rizik DG, Teirstein PS, et al; ABSORB III Investigators. Everolimus-Eluting Bioresorbable Scaffolds for Coronary Artery Disease. N Engl J Med. 2015;373:1905-15. [PMID: 26457558] doi:10.1056/NEJMoa1509038 CrossrefMedlineGoogle Scholar8. Zhang XL, Zhu QQ, Kang LN, Li XL, Xu B. Mid- and long-term outcome comparisons of everolimus-eluting bioresorbable scaffolds versus everolimus-eluting metallic stents. A systematic review and meta-analysis. Ann Intern Med. 2017;167:642-54. doi:10.7326/M17-1101 LinkGoogle Scholar9. Shuren J, Califf RM. Need for a national evaluation system for health technology. JAMA. 2016;316:1153-4. [PMID: 27398696] doi:10.1001/jama.2016.8708 CrossrefMedlineGoogle Scholar Author, Article, and Disclosure InformationAffiliations: From Yale University School of Medicine, New Haven, Connecticut.Disclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M17-2522.Corresponding Author: Jeptha P. Curtis, MD, Section of Cardiovascular Medicine, Yale University School of Medicine, Dana 3, 789 Howard Avenue, New Haven, CT 06520; e-mail, jeptha.[email protected]edu.Current Author Addresses: Dr. Dhruva: Yale University School of Medicine, 333 Cedar Street, SHM I-456, Box 208088, New Haven, CT 06520.Dr. Curtis: Section of Cardiovascular Medicine, Yale University School of Medicine, Dana 3, 789 Howard Avenue, New Haven, CT 06520.This article was published at Annals.org on 17 October 2017. PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetailsSee AlsoMid- and Long-Term Outcome Comparisons of Everolimus-Eluting Bioresorbable Scaffolds Versus Everolimus-Eluting Metallic Stents Xin-Lin Zhang , Qing-Qing Zhu , Li-Na Kang , Xue-Ling Li , and Biao Xu Metrics Cited byAttribution of Adverse Events Following Coronary Stent Placement Identified Using Administrative Claims Data 7 November 2017Volume 167, Issue 9Page: 675-676KeywordsCardiology and cardiovascular diseasesComputed axial tomographyFood and Drug AdministrationLesionsMyocardial infarctionRevascularizationSafetyStent implantationSystematic reviewsThrombosis ePublished: 17 October 2017 Issue Published: 7 November 2017 Copyright & PermissionsCopyright © 2017 by American College of Physicians. All Rights Reserved.PDF downloadLoading ...