FDA Approves Expanded Indication for Medtronic's Pipeline Flex Embolization Device
February 7, 2019—Medtronic announced that it has received FDA approval of an expanded indication for its Pipeline Flex embolization device. In the United States, the Pipeline Flex device is intended for use for the endovascular treatment of complex wide-necked intracranial aneurysms (IAs) located in the internal carotid artery (ICA), attached to parent vessels measuring between 2 and 5 mm in diameter.
According to the company, the device was previously indicated for the endovascular treatment of adults with large or giant wide-necked IAs in the ICA from the petrous to the superior hypophyseal segments. The new indication includes treatment of patients with small or medium, wide-necked brain aneurysms in the territory from the petrous to the terminus of the ICA.
Medtronic advised that approval of the expanded indication was based on clinical data from the PREMIER trial, a prospective study of safety and efficacy of embolization of intracranial aneurysms with the Pipeline device for a broader patient population. Investigators analyzed data from 141 patients with a mean aneurysm size of 5 ± 1.92 mm. The 1-year occlusion rate was 76.7% with the use of 1.1 devices per patient on average and a 2.2% occurrence of major stroke or neurologic death.
Ricardo Hanel, MD, who serves as principal investigator for the PREMIER trial, commented in Medtronic's announcement, "PREMIER is another landmark study with Pipeline and moves the bar on the safe treatment of wide-necked brain aneurysms. This data change the way we, as physicians, think about using Pipeline Flex to treat our patients."
advertisement
Featured Video
Valiant Navion™ Thoracic Stent Graft System
Sponsored by Medtronic UC201907188EE
Related Articles
Ask the Experts: What Is the Biggest Unanswered Question in Ischemic Stroke Care?
Experts discuss who shouldn’t be treated, improving center-to-center communication, triaging patients to the right center for care, and reigning in estimates on large vessel occlusions appropriate for treatment.
With Blaise Baxter, MD; Ronil V. Chandra, MBBS, MMed, FRANZCR, CCINR; Mayank Goyal, MD, FRCPC, FAHA, FCAHS; and Ansaar T. Rai, MD, MBA
Cerebral Aneurysm Follow-Up: How Standards Have Changed and Why
A perspective on the optimal follow-up frequency and imaging modality type for treated cerebral aneurysms.
By Reade De Leacy, MD, FRANZCR; Gal Yaniv, MD, PhD; and Kambiz Nael, MD
Next Horizons in Neurointervention
By Guilherme Dabus, MD, FAHA
Top 5 Articles From January 2019
Vascular Coding Updates for 2019
Changes to the interventional CPT codes for 2019 and how they will affect your practice.
By Katharine L. Krol, MD, FSIR, FACR
Differential Diagnosis of Aortic Pathologies
Practical advice from initial presentation through long-term management of acute aortic syndrome and symptomatic aneurysms.
By Graeme E. McFarland, MD; and Adam W. Beck, MD, FACS
Iliac Intervention and Management of the Challenging Bifurcation and Distal EIA
An overview of proper stent selection and technique for treating aortoiliac occlusive disease.
By Jean Bismuth, MD
CLI: When Is Enough, Enough?
Decisions regarding revascularization options for CLI to optimize wound perfusion and allow rapid wound healing and limb salvage.
By Ahmad Younes, MD; and Mehdi H. Shishehbor, DO, MPH, PhD
SFA Disease: Deciding What to Leave Behind
Evaluating the value of drug delivery and the role of permanent implants in treating superficial femoral artery disease.
By Mark W. Burket, MD
Top 5 from CIToday's Current Issue
Radial Artery Access
By Ted E. Feldman, MD, MSCAI, FACC, FESC
Radial Access Best Practices in 2019
An update on procedural considerations for transradial artery access based on the most recent data.
By Linda M. Koshy, MD; Matthew Schoenfeld, MD; and Binita Shah, MD, MS
2019 CMS Reimbursement and Your Ambulatory Strategy
As trends in health care continue to move toward ambulatory surgery centers, will you be ready to take advantage of the benefits they can offer?
With Tony Lafata; Marc Toth, CMAA; and Jacob Turmell, DNP, RN, NP-C, ACNS-BC, CCRN-CMC
Navigating Complex Radial Loops
An overview on radial loops and the techniques to circumvent them.
By Shing-Chiu Wong, MD; and Salil Desai, MD
Beyond Radial: Ulnar, Snuffbox, and Palmar Branch Access
A review of the limitations of transradial access and the benefits and challenges of alternative approaches for cardiac catheterization.
