Technology | Stents Drug Eluting | December 13, 2017

Cordis and Medinol Announce FDA Approval of EluNIR Drug-Eluting Stent System

EluNIR shown to effectively treat highly complex disease with optimized stent and delivery system

Cordis and Medinol Announce FDA Approval of EluNIR Drug-Eluting Stent System

December 13, 2017 — Cordis, a Cardinal Health company, and Medinol recently announced U.S. Food and Drug Administration (FDA) approval of the EluNIR drug-eluting stent (DES) for the treatment of patients with narrowing or blockages to their coronary arteries. The EluNIR stent system is designed with a novel metallic spring tip and the narrowest strut width of any stent on the U.S. market, according to the companies, to help clinicians easily deliver this new DES in highly complex anatomy and disease.

The EluNIR DES demonstrated outstanding efficacy and safety results in two randomized clinical trials, including BIONICS, a global pivotal study of 1,919 patients from 76 sites in eight countries. In BIONICS, the EluNIR stent demonstrated a 5.4 percent target lesion failure (TLF) and a 0 percent rate of late stent thrombosis at 12 months. Medinol recently obtained CE-mark for the EluNIR stent, and it is currently being used by physicians in Europe.

"The BIONICS study demonstrated the excellent performance of the EluNIR DES in a broad, less selected, ‘more comers’ population," said David Kandzari, M.D., FACC, director of interventional cardiology at Piedmont Heart Institute in Atlanta, and principal investigator for the BIONICS trial. “Clinicians now have another safe, reliable option for treating the many patients whose lives are impacted by coronary artery disease."

Cardinal Health’s long-term distribution agreement with Medinol enables Cordis, Cardinal Health’s interventional vascular business, to sell Medinol’s coronary stent portfolio, which now includes the EluNIR DES and NIRxcell, a cobalt-chromium bare metal stent (BMS), in the U.S.

For more information: www.cordis.com, www.medinol.com

Related Content

Philips Showcases Integrated Solutions for Cardiovascular Care at TCT 2018
News | Cath Lab | September 20, 2018
At the Transcatheter Cardiovascular Therapeutics (TCT) annual meeting, Sept. 21–25 in San Diego, Philips is showcasing...
Sponsored Content | Videos | Cath Lab | September 19, 2018
William O’Neill, M.D., outlines his recent clinical publication of AMICS patients from the Impella Quality (IQ) datab
Videos | Cath Lab | September 14, 2018
A discussion with Nicolas Bevins, Ph.D., vice chair, physics and research, and Jessica Harrington, RCIS.
A complex PCI case to revascularize a chronic total occlusion (CTO) at Henry Ford Hospital in Detroit. Complex PCI and CHIP cases are increasing patient volumes in the cath lab and using a minimally invasive approach in patients who otherwise would have been sent for CABG. Pictured is Khaldoon Alaswad, M.D. DAIC staff photo by Dave Fornell

A complex PCI case to revascularize a chronic total occlusion (CTO) at Henry Ford Hospital in Detroit. Complex PCI and CHIP cases are increasing patient volumes in the cath lab and using a minimally invasive approach in patients who otherwise would have been sent for CABG. Pictured is Khaldoon Alaswad, M.D. (right) who is proctoring a fellow in treating CTOs.

Feature | Cath Lab | September 13, 2018 | Artur Kim, Kamran Zamanian
Coronary artery disease (CAD) is a multifaceted disease that demands various approaches in terms of diagnosis and tre
Videos | Cath Lab | August 13, 2018
Jeffrey Schussler, M.D., FACC, FSCAI, FSCCT, FACP, interventional cardiologist at Baylor Scott White Heart and Vascul
Shockwave Launches Coronary Intravascular Lithotripsy in Europe
News | Cath Lab | May 30, 2018
Shockwave Medical recently announced the European commercial availability of Intravascular Lithotripsy (IVL) for...
FFR software on the GE Centricity CVIS. A trial from the 2018 EuroPCR meeting showed FFR improves long-term outcomes.
News | Cath Lab | May 29, 2018
May 29, 2018 — Ongoing controversy exists regarding the role of percutaneous coronary intervention (PCI) for stable c
SCAI Updates Consensus on Length of Stay for Percutaneous Coronary Intervention
News | Cath Lab | May 15, 2018
Revised guidelines incorporating new data on discharge criteria for patients undergoing elective percutaneous coronary...
No Benefit Found Using Sodium Bicarbonate, Acetylcysteine to Prevent Kidney Injury, the result of the PRESERVE Trial to prevent acute kidney injury (AKI), presented at SCAI 2018.  #SCAI, #SCAI2018,
Feature | Cath Lab | May 15, 2018
May 15, 2018 – The large-scale, international randomized PRESERVE clinical trial found high-risk patients for renal c
Angiogram of a STEMI patient.
News | Cath Lab | May 15, 2018
May 15, 2018 — A contemporary, real-world analysis shows lower mortality rates when culprit-only intervention is used
Overlay Init