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

Detroit Medical Center Heart Hospital Uses Michigan's First EluNIR Drug-Eluting Stent
News | Stents Drug Eluting | February 19, 2018
February 19, 2018 — The Detroit Medical Center’s (DMC) interventional cardiology team at Heart Hospital recently beca
Biotronik Symposium Highlights Differing Roles of Drug-Eluting Stents and Magnesium Scaffolds in Clinical Practice
News | Stents Drug Eluting | January 25, 2018
January 25, 2018 – Data presented at the Biotronik-sponsored...
The Abbott Absorb Bioresorbable Vascular Scaffold (BVS) bioabsorbable stent.

The Abbott Absorb Bioresorbable Vascular Scaffold (BVS).

Feature | Stents Drug Eluting | January 17, 2018 | Dave Fornell
There was no shortage of interest in bioresorbable stent technologies at the many sessions offered on this topic or b
Cordis and Medinol Announce FDA Approval of EluNIR Drug-Eluting Stent System
Technology | Stents Drug Eluting | December 13, 2017
Cordis, a Cardinal Health company, and Medinol recently announced U.S. Food and Drug Administration (FDA) approval of...
The Xience Sierra stent.
Technology | Stents Drug Eluting | November 09, 2017
November 9, 2017 — Abbott received European CE mark for Xience Sierra, the newest generation of the company's Xience
Synergy Stent With Shorter DAPT Superior to Bare-Metal Stent in Elderly Patients
News | Stents Drug Eluting | November 06, 2017
November 6, 2017 — Elderly patients undergoing...
Biotronik Orsiro DES Shows Low Five-Year Event Rates
News | Stents Drug Eluting | November 03, 2017
November 3, 2017 — Biotronik's Orsiro...
Three-Month DAPT Non-Inferior for ACS Patients Treated With Combo Dual Therapy Stent

Image courtesy of OrbusNeich

News | Stents Drug Eluting | November 01, 2017
OrbusNeich reported results from the REDUCE trial in the Late-Breaking Clinical Trial session at the 29th annual...
News | Stents Drug Eluting | October 25, 2017
Elixir Medical Corp. announced it will unveil a new metallic drug-eluting stent (DES) platform at this year’s...
Biotronik's Orsiro Drug-Eluting Stent Outperforms Xience in BIOFLOW-V Trial
News | Stents Drug Eluting | September 01, 2017
September 1, 2017 — Biotronik recently announced data from the BIOFLOW-V randomized trial comparing Orsiro and Xience
Overlay Init