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

TCT cancels in-person meeting and goes virtual due to COVID-19
News | Cath Lab | May 27, 2020
May 27, 2020 — To ensure the health and safety of all attendees due to the ongoing COVID-19 (SARS-CoV-2) pandemic, th
Patients undergoing cardiac catheterization are traditionally instructed to follow nothing by mouth, or nil per os (NPO), as there are no current standardized fasting protocols, but the CHOWNOW study found patients do not need to fast and will have similar outcomes. #SCAI2020
Feature | Cath Lab | May 18, 2020
May 18, 2020 – Patients undergoing cardiac catheterization are traditionally instructed to follow nothing by mouth, o
htisham Mahmud, M.D., FSCAI, president of the Society for Cardiovascular Angiography and Interventions (SCAI) and chief, Division of Cardiovascular Medicine at UC San Diego Medical Center,
Podcast | Cath Lab | May 13, 2020
This podcast is an interview with Ehtisham Mahmud, M.D., FSCAI, president of the Society for Cardiovascular Angiograp
Nuance Communications Inc. introduced Nuance Cardiovascular CAPD, a new computer-assisted physician documentation (CAPD) solution designed to help cardiologists improve the quality of complex documentation and the accuracy of reimbursement for cardiac catheterization procedures. The Nuance Cardiovascular CAPD solution is available through a partnership with ZHealth for this solution, which is based on patented algorithms built with ZHealth’s interventional documentation and coding expertise.
News | Cath Lab | January 31, 2020
January 29, 2020 – Nuance Communications Inc.
Videos | Cath Lab | January 09, 2020
Haval Chweich, M.D., medical director of the cardiac critical care unit (CCU) at Tufts Medical Center, and assistant...
People watch the live presentation of the five-year EXCEL Trial data by Gregg Stone, M.D., in the Abbott booth at TCT 2019. Abbott makes the Xience stent used in the trial, which compared equally with long-term CABG surgical outcomes.  In early December 2019, leaders of the European Association for Cardiothoracic Surgery (EACTS) withdrew their support for European practice guidelines that endorse the use of coronary stents in many patients with left main coronary artery disease.

People watch the live presentation of the five-year EXCEL Trial data by Gregg Stone, M.D., in the Abbott booth at TCT 2019. Abbott makes the Xience stent used in the trial, which compared equally with long-term CABG surgical outcomes.

News | Cath Lab | January 02, 2020 | Dave Fornell, Editor
January 2, 2020 — In early December 2019, leaders of the European As...