News | Stents Drug Eluting | January 10, 2017

Medinol Announces Positive 12-Month Trial Results for EluNIR Drug-Eluting Stent

Elastomer-coated DES shows identical target lesion failure, low definite/probable stent thrombosis rate compared to Resolute Integrity stent

Medinol, BIONICS study, 12-month results, TCT 2016, drug-eluting stent, EluNIR

January 10, 2017 — Medinol announced in December positive twelve-month clinical results from the BIONICS study. The study was conducted to evaluate EluNIR, Medinol's novel coronary stent system and the first ever elastomer-coated drug eluting stent (eDES), according to the company.

This global pivotal study enrolled 1,919 patients from 76 sites in eight countries. The BIONICS results were highlighted in the opening Late Breaking Trial session of the 28th annual Transcatheter Cardiovascular Therapeutics (TCT2016) scientific symposium, Oct. 29-Nov. 2 in Washington, D.C. The study data will be submitted to the U.S. Food and Drug Administration (FDA) to support the U.S. regulatory approval of EluNIR for the treatment of patients with narrowing or blockage of their coronary arteries.

The BIONICS study — a global, prospective, randomized, multicenter, non-inferiority clinical trial — was designed to include a "more comers" population, i.e. one that closely represents the real-world patient population. The EluNIR Stent (study name BioNIR) was compared to the Resolute Integrity Stent (1:1 randomization). Key results from the study include:

  • For its primary endpoint of target lesion failure (TLF), EluNIR demonstrated a rate of 5.4 percent at 12 months compared to an identical rate of 5.4 percent for Resolute (p=0.0013 for non-inferiority). TLF was defined as the composite of cardiac death, target vessel MI and clinically driven TLR; and
  • Good safety profile, with a low definite/probable stent thrombosis rate of 0.4 percent for EluNIR, compared to 0.8 percent for Resolute (p=NS), with no events beyond 30 days for EluNIR.    

"The BIONICS data validated that the EluNIR stent performed very well in a more broad, less selected 'more comers' population than has previously been studied for most other DES," said David Kandzari, M.D., F.A.C.C., director of interventional cardiology at Piedmont Heart Institute, Atlanta, and principal investigator for the BIONICS trial. "These results establish the excellent clinical performance of this stent, and we look forward to seeing the angiographic data over the next few months to further support its efficacy."

In addition to the BIONICS study, new twelve-month data from NIREUS, the European pivotal trial for EluNIR, were presented at TCT. The NIREUS study — a prospective, multi-center, randomized, non-inferiority pivotal study comparing EluNIR to the Resolute Integrity Stent — met its non-inferiority primary endpoint of angiographic in-stent late loss at six months. These data were presented at EuroPCR in May 2016. The recent twelve-month clinical data, presented TLF of 3.4 percent for EluNIR and 5.9 percent for Resolute (p=NS).These outcomes were consistent with the positive results of BIONICS.

For more information: www.medinol.com

Related Content

News | Stents | July 24, 2020
July 24, 2020 — CeloNova BioSciences Inc.
Coronary and Peripheral Stent Market Expected to Double Through 2025
News | Stents | May 28, 2020
May 28, 2020 — The rising incidence of cardiovascular disease has prompted people to seek timely treatment to improve
The Boston Scientific Synergy stent uses a unique abluminal, bioresorbable drug-carrier polymer that dissolves after the vessel wall has healed months after the stent is implanted. Stent polymers have been implicated in cases of late-stent thrombosis, which required patients with DES to stay on dual antiplatelet therapy (DAPT). This study looked at using the device as a way to shorten DAPT duration. #SCAI2020

The Boston Scientific Synergy stent uses a unique abluminal, bioresorbable drug-carrier polymer that dissolves after the vessel wall has healed months after the stent is implanted. Stent polymers have been implicated in cases of late-stent thrombosis, which required patients with DES to stay on dual antiplatelet therapy (DAPT). This study looked at using the device as a way to shorten DAPT duration.

News | Stents | May 17, 2020
May 17, 2020 – A new study sought to reveal whether drug-eluting stents (DES) coated with bioabsorbable polymer (BP)
Biotronik announced three-year data from the BIOFLOW-V Trial, which was presented yesterday at the 2020 Cardiovascular Research Technologies (CRT) Congress. The three-year follow-up data demonstrates consistently lower clinical event rates and improvement in patient outcomes, reinforcing the differentiation of the Orsiro coronary drug-eluting stent (DES), which is the first DES to outperform Xience.
News | Stents | February 24, 2020
February 24, 2020 — Biotronik announced three-year data from the...
The Boston Scientific Eluvia self-expanding, drug-eluting, peripheral stent.

The Boston Scientific Eluvia self-expanding, drug-eluting, peripheral stent.

Feature | Stents | February 11, 2020 | Saloni Walimbe
Cardiovascular diseases (CVDs) are among the leading causes of death across the globe.
Global Cardiovascular Stent Market Poised for Almost 7 Percent Growth Through 2025
News | Stents | August 21, 2019
Increasing incidence of cardiovascular diseases worldwide is creating growth opportunities for the global...
The U.S. Food and Drug Administration (FDA) recently granted an additional indication to Bard Peripheral Vascular's Covera Vascular Covered Stent for the treatment of a stenosis or blockage which has developed anywhere in the access circuit of patients on hemodialysis using an arteriovenous (AV) fistula.
Technology | Stents | April 03, 2019
April 3, 2019 — The U.S.

A comparison of stent strut thickness between the Orsiro stent, pictured, and the market-leading stents on the U.S. and European markets. Vendors have been working toward reducing strut thickness to help improve overall clinical outcomes. Orsiro is now the smallest strut stent available on the market. 

Feature | Stents | February 22, 2019 | Dave Fornell, Editor
February 22, 2019 — The U.S.
The Medtronic Resolute Integrity drug-eluting stent is among the top three stents on the U.S. market. Outcomes for these stents are very similar, so the stents have largely become a commodity product purchased on price rather than clinical data. Stent advances and new stent technologies.

The Medtronic Resolute Integrity drug-eluting stent (DES) is among the top three stents on the U.S. market. Outcomes for these stents are very similar, so the stents have largely become a commodity product purchased on price rather than clinical data.

Feature | Stents | January 29, 2019 | Dave Fornell, Editor
There was a lot of hype and high hopes pinned on bioresorbable stent technologies as the way of the future two years
The Indian-made SMT SuperFlex stent. SMT has been developing stents and other interventional products designed to be a more affordable, home-grown option for the growing Indian market.

The Indian-made SMT SuperFlex stent. SMT has been developing stents and other interventional products designed to be a more affordable, home-grown option for the growing Indian market.

News | Stents | January 22, 2019
The rise cardiovascular disease has been instrumental in fueling the coronary stent market share in the past few year