DUBLIN, Ohio, Nov. 30, 2017 /PRNewswire/ -- Cordis, a
Cardinal Health company, and Medinol today announced United States
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 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), the lowest reported TLF in a
contemporary U.S. pivotal study, and a zero 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., F.A.C.C.,
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.
"The FDA approval of the EluNIR™ stent expands the Cordis
portfolio with a DES designed for deliverability, in
even highly complex cases, with its novel stent and delivery
system," said Luis Davila, vice
president of R&D at Cordis. "Cordis is committed to ensuring
physicians will soon have this new DES in their Cath Labs to deliver the best patient care
available."
"Medinol has a legacy of developing innovative interventional
cardiovascular technologies, which has culminated today with the
FDA approval of the EluNIR™ DES," said Dr. Yoram Richter, chief scientific officer at
Medinol. "For more than 20 years, Medinol has continuously raised
the bar for the quality and performance of stenting systems. With
our innovative manufacturing process, the EluNIR™ DES offers
clinicians the latest generation DES. Notably, the FDA approval of
the EluNIR™ DES marks the first such approval for a privately held
company based outside of the U.S."
About Percutaneous Coronary Intervention (PCI)
PCI is
a nonsurgical procedure that often uses a catheter to place a stent
to open blocked coronary arteries caused by coronary artery
disease, which is a common type of cardiovascular disease.
Cardiovascular disease is the leading global cause of death,
accounting for more than 17.3 million deaths per year in 2013, a
number that is expected to grow to more than 23.6 million by 2030.
In the U.S., about 2,200 people die of cardiovascular disease each
day, an average of one death every 40 seconds.i
About Medinol
Medinol was founded in 1992 by
Drs. Judith and Kobi Richter. It's a
privately held company with offices in the U.S. and Israel and employs more than 400 people.
Medinol has an extensive patent portfolio, including a long,
established history in the coronary stent market over the past 20
years. The unique design of its products, along with its rigorous
standards of manufacturing and safety, makes Medinol a leading
developer in this space. All Medinol's cardiovascular intervention
solutions are manufactured in-house using its proprietary
QualitySurface™ manufacturing technology. This unique manufacturing
method enables Medinol to conduct strict and automated quality
control on each individual stent, ensuring consistently exceptional
product quality and safety. Medinol's EluNIR™ DES was developed to
offer clinicians a new generation DES with an optimized stent and
delivery system. With more than two million stents delivered
globally to date, Medinol's cutting-edge cardiovascular
intervention technology continues to demonstrate extraordinary
clinical results.
About Cardinal Health
Cardinal Health, Inc. is a
global, integrated healthcare services and products company,
providing customized solutions for hospitals, healthcare systems,
pharmacies, ambulatory surgery centers, clinical laboratories and
physician offices worldwide. The company provides clinically proven
medical products and pharmaceuticals and cost-effective solutions
that enhance supply chain efficiency from hospital to home.
Cardinal Health connects patients, providers, payers, pharmacists
and manufacturers for integrated care coordination and better
patient management. Because Cardinal Health helps ensure
pharmacists and the consumers they serve have access to medications
they need while working to help prevent prescription drug
diversion, the company and its education partners created
Generation Rx, a national program to help prevent the misuse of
prescription medications. Backed by nearly 100 years of experience,
with approximately 50,000 employees in nearly 60 countries,
Cardinal Health ranks #15 on the Fortune 500. For more
information, visit cardinalhealth.com, follow @CardinalHealth on
Twitter and connect on LinkedIn at
linkedin.com/company/cardinal-health.
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https://www.heart.org/idc/groups/ahamah-public/@wcm/@sop/@smd/documents/downloadable/ucm_491265.pdf
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SOURCE Cardinal Health