Overview of the 2018 US Food and Drug Administration Circulatory System Devices Panel meeting on the INCRAFT AAA Stent Graft System.

MedStar author(s):
Citation: Cardiovascular Revascularization Medicine. 20(5):403-408, 2019 05.PMID: 30879790Institution: MedStar Heart & Vascular InstituteForm of publication: Journal ArticleMedline article type(s): Journal ArticleSubject headings: *Aortic Aneurysm, Abdominal/su [Surgery] | *Blood Vessel Prosthesis | *Blood Vessel Prosthesis Implantation/is [Instrumentation] | *Device Approval | *Endovascular Procedures/is [Instrumentation] | *Stents | *United States Food and Drug Administration | Aortic Aneurysm, Abdominal/dg [Diagnostic Imaging] | Blood Vessel Prosthesis Implantation/ae [Adverse Effects] | Endoleak/et [Etiology] | Endovascular Procedures/ae [Adverse Effects] | Evidence-Based Medicine | Humans | Patient Safety | Prosthesis Design | Prosthesis Failure | Risk Assessment | Risk Factors | Time Factors | Treatment Outcome | United StatesYear: 2019Local holdings: Available in print through MWHC library: 2002 - presentISSN:
  • 1878-0938
Name of journal: Cardiovascular revascularization medicine : including molecular interventionsAbstract: Copyright (c) 2019 Elsevier Inc. All rights reserved.On June 12, 2018, the US Food and Drug Administration (FDA) convened a meeting of the Circulatory System Devices Panel to advise on the safety and effectiveness of the INCRAFT AAA Stent Graft System for the treatment of abdominal aortic aneurysms (AAA) and to consider a premarket approval application sponsored by Cordis, Inc., for Unique identifier: NCT01664078 based on the results of the pivotal INSPIRATION trial (URL: https://clinicaltrials.gov/ct2/show/NCT01664078). The INCRAFT AAA Stent Graft System is designed for endovascular repair of infrarenal AAAs with complex aortic anatomies. The stent-graft system utilizes nitinol stent and polyester graft technology in an ultra-low profile delivery system, with the goal of isolating the aneurysmal sac and preventing sac rupture. The multicenter, prospective, non-randomized investigation trial met its primary composite safety and effectiveness endpoints but also showed higher-than-anticipated rates of stent fracture and endoleaks. The committee discussion focused on how these events impact the long-term safety and effectiveness, as well as the benefit/risk profile, of the device. While the panel acknowledged the risk of the device, the panel's final vote supported that the benefits of the INCRAFT AAA Stent Graft System outweigh the risks and that a post-marketing study should be mandated. The FDA approved the device for use in complex access anatomies in December 2018.All authors: Bernardo NL, Buchanan KD, Iantorno M, Torguson R, Waksman ROriginally published: Cardiovascular Revascularization Medicine. 20(5):403-408, 2019 May.Fiscal year: FY2019Digital Object Identifier: Date added to catalog: 2019-05-21
Holdings
Item type Current library Collection Call number Status Date due Barcode
Journal Article MedStar Authors Catalog Article 30879790 Available 30879790

Available in print through MWHC library: 2002 - present

Copyright (c) 2019 Elsevier Inc. All rights reserved.

On June 12, 2018, the US Food and Drug Administration (FDA) convened a meeting of the Circulatory System Devices Panel to advise on the safety and effectiveness of the INCRAFT AAA Stent Graft System for the treatment of abdominal aortic aneurysms (AAA) and to consider a premarket approval application sponsored by Cordis, Inc., for Unique identifier: NCT01664078 based on the results of the pivotal INSPIRATION trial (URL: https://clinicaltrials.gov/ct2/show/NCT01664078). The INCRAFT AAA Stent Graft System is designed for endovascular repair of infrarenal AAAs with complex aortic anatomies. The stent-graft system utilizes nitinol stent and polyester graft technology in an ultra-low profile delivery system, with the goal of isolating the aneurysmal sac and preventing sac rupture. The multicenter, prospective, non-randomized investigation trial met its primary composite safety and effectiveness endpoints but also showed higher-than-anticipated rates of stent fracture and endoleaks. The committee discussion focused on how these events impact the long-term safety and effectiveness, as well as the benefit/risk profile, of the device. While the panel acknowledged the risk of the device, the panel's final vote supported that the benefits of the INCRAFT AAA Stent Graft System outweigh the risks and that a post-marketing study should be mandated. The FDA approved the device for use in complex access anatomies in December 2018.

English

Powered by Koha