Technology | July 16, 2015

Medtronic's Protege GPS Self-Expanding Peripheral Stent Receives FDA Approval

Device indicated for treatment of iliac artery stenosis

Medtronic, Protege GPS self-expanding peripheral stent, FDA approval

July 16, 2015 — Medtronic plc announced that its Protege GPS self-expanding peripheral stent system has received approval from the U.S. Food and Drug Administration (FDA) for the treatment of stenotic lesions of the common and external iliac arteries. 

The news follows the nine-month results of the DURABILITY Iliac study, which were presented at the 2014 VIVA (Vascular Interventional Advances) conference in Las Vegas. The results demonstrated the safety and effectiveness of the Protege GPS peripheral stent system in the treatment of stenotic lesions of the common and external iliac arteries.  The prospective, multi-center, non-randomized clinical study demonstrated 95.8 percent nine-month primary patency (the ability for the treated artery to remain open) by Kaplan-Meier analysis and 98.6 percent freedom from target vessel revascularization (no repeat procedure).

"When used for iliac angioplasty and stenting, the Protege GPS self-expanding peripheral stent system demonstrated excellent patency rates even in difficult-to-treat calcified lesions," said Peter Faries, M.D., co-national principal investigator of the DURABILITY Iliac study, Mount Sinai School of Medicine, New York. "Data from the DURABILITY Iliac study confirms the safety and effectiveness of the Protege GPS stent. It is gratifying to see that the FDA has approved this stent for the iliac indication."

Iliac stenosis occurs when plaque builds up in the iliac artery, which can block the blood supply to the entire leg. As a result, patients with iliac artery stenosis can experience pain that can limit mobility.

The self-expanding peripheral stent system allows physicians to treat iliac artery lesions and restore blood flow with large diameter stents through a low-profile 6 French delivery system. The stent is cut from a nitinol tube into an open lattice design and has tantalum radiopaque markers at the proximal and distal ends of the stent. Upon deployment, the stent achieves its predetermined diameter and exerts a constant, outward force to restore patency.

For more information: www.medtronic.com

Related Content

Tryton Side Branch Stent Recognized With Premier Technology Breakthrough Award
News | Stents Bifurcation| September 21, 2017
September 21, 2017 — Cardinal Health and Tryton Medical Inc.
Lesion Preparation Via Atherectomy Enhances Paclitaxel Distribution in Calcified Peripheral Arteries
News | Peripheral Artery Disease (PAD)| September 20, 2017
September 20, 2017 — Not-for-profit preclinical research institute CBSET announced that its scientists have published
DISRUPT BTK Study Shows Positive Results With Lithoplasty in Calcified Lesions Below the Knee
News | Peripheral Artery Disease (PAD)| September 20, 2017
Shockwave Medical reported positive results from the DISRUPT BTK Study, which were presented at the annual...
Corindus Announces First Patient Enrolled in PRECISION GRX Registry
News | Robotic Systems| September 18, 2017
September 18, 2017 — Corindus Vascular Robotics Inc.
Two-Year ILLUMENATE Trial Data Demonstrate Efficacy of Stellarex Drug-Coated Balloon
News | Drug-Eluting Balloons| September 18, 2017
Philips announced the two-year results from the ILLUMENATE European randomized clinical trial (EU RCT) demonstrating...
Sentinel Cerebral Protection System Significantly Reduces Stroke and Mortality in TAVR
News | Embolic Protection Devices| September 18, 2017
September 18, 2017 – Claret Medical announced publication of a new study in the...
Fysicon Receives FDA Approval for QMAPP Hemodynamic Monitoring System
Technology | Hemodynamic Monitoring Systems| September 18, 2017
Fysicon announced that it has been granted 510(k) clearance by the U.S. Food and Drug Administration (FDA) for its...
Peter Schneider, M.D. presents late breaking clinical trial results at VIVA 17 in Las Vegas. Panelists (l to r) Krishna Rocha-Singh, M.D., Sean Lyden, M.D., John Kaufman, M.D., Donna Buckley, M.D.

Peter Schneider, M.D. presents late breaking clinical trial results at VIVA 17 in Las Vegas. Panelists (l to r) Krishna Rocha-Singh, M.D., Sean Lyden, M.D., John Kaufman, M.D., Donna Buckley, M.D.

Feature | Cath Lab| September 14, 2017
September 14, 2017 — Here are quick summaries for all the key late-breaking vascular and endovascular clinical trials
Mississippi Surgical and Vascular Center Uses Toshiba Ultimax-i FPD to Save Patients' Limbs
News | Angiography| September 14, 2017
The southern U.S. sees some of the highest numbers of chronic medical conditions, such as peripheral artery disease...
Sponsored Content | Videos | Structural Heart Occluders| September 13, 2017
Ziyad Hijazi, M.D., MPH, MSCAI, FACC, director of the cardiac program and chair of the Department of Pediatrics at Si
Overlay Init