Technology | December 02, 2013

FDA Clears Boston Scientific’s Promus Premier Everolimus-Eluting Coronary Stent

Stent technology launches in United States

cath lab stents drug eluting boston scientific promus premier
December 2, 2013 — Boston Scientific Corporation has received U.S. Food and Drug Administration (FDA) approval for the Promus Premier Everolimus-Eluting Platinum Chromium Coronary Stent System, the company's durable polymer drug-eluting stent (DES).
 
The technology is available immediately in the United states, with the first implantation scheduled to be performed by Martin Leon, M.D., director, Center for Interventional Vascular Therapy, Columbia University Medical Center / NewYork-Presbyterian Hospital, New York City.
 
"Perhaps the most impressive benefit of the Promus Premier Stent System is its unparalleled visibility, which combined with enhanced customized stent architecture, leads to an advance in currently available durable polymer DES," said Leon.
 
The Promus Premier Stent System offers physicians improved DES performance in treating patients with coronary artery disease (CAD) and features unique, customized platinum chromium alloy stent architecture, the Everolimus drug with a biocompatible, fluorinated co-polymer and an enhanced stent delivery system.
 
"After using this product for nearly a year, I am confident that Boston Scientific has advanced thin-strut technology," said John Ormiston, M.D., Mercy Angiography Auckland Hospital, Auckland, New Zealand. "The customized platinum chromium stent architecture maintains excellent radial strength and flexibility along with optimal radiopacity while offering improved longitudinal strength. In addition, the enhanced stent delivery system contributes to superior stent deliverability."
 
The Promus Premier Stent System was developed with input from interventional cardiologists and is designed to provide acute and clinical outcomes. It features high visibility, low recoil, radial strength and fracture resistance while improving axial strength and deliverability.  An enhanced low-profile delivery system features a shorter, more visible tip, a dual-layer balloon and a Bi-Segment inner lumen catheter designed to facilitate precise stent delivery across challenging lesions.
 
The Everolimus drug and PVDF-HFP stent coating have been studied in multiple randomized clinical trials demonstrating long-term safety and efficacy. The PLATINUM Clinical Trial Program demonstrated exceptional safety and efficacy of the Promus Element Stent System (platinum chromium everolimus-eluting stent) when compared to the Xience V Stent (cobalt chromium everolimus-eluting stent), including a significant reduction in bail-out stenting, providing an average of $116 in savings per procedure. Further review of the Platinum data demonstrated that the Promus Element Stent System is associated with significantly less vessel straightening in severely angulated lesions and resulted in numerically lower clinical event rates out to three years.
 
The Promus Premier Stent System is offered in a matrix of 94 sizes, ranging in diameter from 2.25 mm to 4 mm and lengths of 8 mm to 38 mm on both Monorail and Over-the-Wire catheter platforms. This provides physicians and their patients with a broad range of options designed to best suit their needs. The company received CE mark approval for the Promus Premier Stent System in February 2013.
 
For more information: www.bostonscientific.com

Related Content

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
Philips Showcases Integrated Vascular Solutions at VIVA 2017
News | Peripheral Artery Disease (PAD)| September 13, 2017
Philips announced its presence at the Vascular Interventional Advances (VIVA 17) Annual Conference in Las Vegas from...
Medtronic Announces Japanese Regulatory Approval for In.Pact Admiral Drug-Coated Balloon
News | Drug-Eluting Balloons| September 13, 2017
Medtronic plc announced that the In.Pact Admiral Drug-Coated Balloon (DCB) received approval from the Japanese Ministry...
Overlay Init