News | October 01, 2010

First U.S. Implants Completed for New SFA Stent

October 1, 2010 – The Bradenton Cardiology Center is the first clinic in the United States to implant a peripheral self-expanding stent as part of the OSPREY study. The trial, which is evaluating the safety and efficacy of Terumo’s Misago stent system in the superficial femoral artery (SFA), will simultaneously enroll patients in the United States and Japan.

OSPREY is one of two trials piloting the Harmonization by Doing (HBD) initiative, which is intended to shorten the gap between product approvals in both countries. The pilot program is a cooperative effort led by the U.S. Food and Drug Administration, the MHLW-PMDA (Japan’s regulatory bodies) and Terumo.

“We are pleased to be the first U.S. center to kick off this exciting international trial to evaluate the safety and efficacy of the Misago stent system for treating patients with peripheral artery disease,” said Srinivas Iyengar, M.D., primary operator and site principal investigator for the OSPREY trial. “This is a unique and exciting opportunity for myself and the Bradenton Cardiology Center to be a part of the first international initiative to streamline the regulatory process to facilitate future medical device approvals between countries.”

In the United States, OSPREY is a single-arm, multi-center, non-randomized prospective clinical trial for the treatment of atherosclerotic stenoses and occlusions of the SFA. In Japan, there are two arms of the study, 50 patients receiving the Misago stent system and 50 patients receiving percutaneous transluminal angioplasty (PTA).

The system consists of a nitinol stent pre-mounted on the distal portion of a rapid-exchange delivery catheter system. The stent has three radiopaque markers located on each end of the stent to help ensure accurate placement in the lesion. The design distributes the dynamic superficial femoral artery stress loads throughout the stent’s struts, providing flexibility and durability against bending, compression and torsion. It also features the first rapid-exchange (RX) delivery catheter for use in the SFA.

The Misago stent system has been available in Europe since November 2007.

For more information: www.terumomedical.com

Related Content

Medtronic Announces Global Resolute Onyx DES One-Month DAPT Study
News | Antiplatelet and Anticoagulation Therapies| August 18, 2017
Medtronic plc announced a global randomized clinical trial that will evaluate one-month dual antiplatelet therapy (DAPT...
Bivalirudin exhibited an improvement in 30-day all-cause mortality when injected post PCI.
News | Antiplatelet and Anticoagulation Therapies| August 16, 2017
August 16, 2017 — A study has examined the efficacies of various post-percutaneous coronary intervention (PCI) bivali
ESC 2017 late breaking trial hot line study presentations.
News | Clinical Study| August 16, 2017
Aug. 16, 2017 – The European Society of Cardiology (ESC) Congress 2017 includes several Hot Line Late-breaking Clinic
News | Drug-Eluting Balloons| August 15, 2017
Surmodics Inc. announced receipt of an investigational device exemption (IDE) from the U.S. Food and Drug...
The Vascular Dynamics MobiusHD device enhances the carotid baroreceptors to reduce resistant hypertension.
News | Hypertension| August 15, 2017
Aug. 15, 2017 — The U.S. Food and Drug Administration (FDA) has approved the Vascular Dynamics Inc.
Abbott Initiates First Clinical Trial of Clip-Based Tricuspid Repair System
News | Heart Valve Technology| August 09, 2017
Abbott announced that the first patient has been enrolled in a clinical study to evaluate a minimally invasive clip-...
Three New Atrial Fibrillation Studies to Feature HeartLight Endoscopic Ablation System
News | Ablation Systems| August 07, 2017
CardioFocus Inc. announced that its HeartLight Endoscopic Ablation System is being featured in three new major clinical...
Registry Identifies Early Onset of Heart Failure and Lack of Defibrillators in Asia
News | Heart Failure| August 03, 2017
August 3, 2017 — The Asian Pacific Society of Cardiology (ASPC) held its first-ever late-breaking...
Overlay Init