News | August 09, 2010

Self-Expanding Peripheral Stent Study Enrollment Completed

August 9, 2010 – Enrollment was recently completed in a clinical trial of Medtronic’s Complete SE (self-expanding) vascular stent for the treatment of atherosclerosis in the superficial femoral artery (SFA), including the proximal popliteal artery (PPA).

Approved by the U.S. Food and Drug Administration (FDA) under an investigational device exemption (IDE), the Complete SE SFA study is a prospective, multicenter, single-arm trial to evaluate the safety and efficacy of the Complete SE vascular stent system in the treatment of de novo and/or restenotic lesions or occlusions in the SFA/PPA. The study enrolled 196 patients with symptomatic, ischemic PAD. The primary endpoints are major adverse events (MAEs) and patency of the stent at 12 months.

PAD of the lower extremities, including the SFA, affects approximately 8 million people in the United States each year, although many patients are unaware of their condition or its consequences. PAD patients have a two- to six-fold increase in cardiovascular mortality and a significantly increased risk of amputation, disability and diminished quality of life.

“Many people are unable to recognize the symptoms of PAD, and the condition is often undiagnosed by healthcare professionals,” said John Laird, M.D., medical director of the Vascular Center at the University of California (UC), Davis, who served as the study’s U.S. principal investigator. “With this trial, Medtronic is partnering with physicians around the world to expand clinical knowledge about a potentially serious health condition while at the same time generating data in support of the safety and efficacy of its Complete SE stent in the treatment of PAD.”

For more information: www.medtronic.com

Related Content

The Biotronik Osiro is an ultra thin strut, sirolimus-eluting stent. #TCT2018

The Biotronik Osiro is an ultra thin strut, sirolimus-eluting stent.

News | Stents | October 04, 2018
October 4, 2018 – Investigators unveiled clinical data from the independent BIONYX and SORT OUT IX all-comers trials
FDA Approves Biotronik's PK Papyrus Stent for Coronary Perforations
Technology | Stents | September 27, 2018
September 27, 2018 — Biotronik recently announced U.S.
Videos | Stents | September 11, 2018
This is an animation showing how the dedicated bifurcation stent developed by Advanced Bifurcation Systems (ABS) is d
Elixir Medical Corporation Unveils Transformational DynamX Stent Featuring Adaptive Segments that Uncage the Stented Artery
News | Stents | January 25, 2018
January 25, 2018 – Elixir Medical Corporation, a leader in the development of breakthrough adaptive remodeling techno
The TIDES-ACS results show us that the Optimax stent is noninferior in patients with acute coronary syndrome compared to Synergy.

The presentation of the ESC late-breaker TIDES-ACS results show us that the Optimax stent is noninferior in patients with acute coronary syndrome compared to Synergy.

News | Stents | November 24, 2017
November 24, 2017 – During a late-breaking session at the European Society of Cardiology (ESC) 2017 meeting, presente
News | Stents | November 10, 2017
Cordis, a Cardinal Health company, recently unveiled a comprehensive interventional cardiology portfolio, which now...
OCT comparison between the Combo vs. Xience stents in the HARMONEE study.

OCT comparison between the Combo vs. Xience stents in the HARMONEE study.

Feature | Stents | November 08, 2017
November 8, 2017 – New results from the HARMONEE Japan/U.S.
FDA Approves COBRA REDUCE Trial of 14-Day DAPT With CeloNova Stent
News | Stents | October 27, 2017
CeloNova BioSciences Inc. announced the U.S. Food and Drug Administration (FDA) approved expansion of CeloNova's...
CeloNova Cobra Pzf stent
Technology | Stents | March 02, 2017
March 2, 2017 — The U.S. Food and Drug Administration (FDA) cleared CeloNova BioSciences Inc.
OCT, intravascular imaging, stent, good stent apposition on vessel wall, TRANSFORM-OCT study

An OCT image showing good stent strut apposition against the vessel wall.

News | Stents | January 13, 2017
January 13, 2017 — Results from TRANSFORM-OCT, a prospective, randomized trial using optical coherence tomography (OC
Overlay Init