Translumina Launches VIVO ISAR, its Dual-Drug Polymer-free Coated Stent (DDCS) in International markets
PR95493
NEW DELHI and HECHINGEN, Germany, April 19, 2022/PRNewswire=KYODO JBN/--
- Launch of novel stent technology with 10-year safety and efficacy data
adds further momentum to the company's global growth journey
Translumina, a global developer and manufacturer of innovative cardiovascular
medical devices used in interventional cardiology, announces the launch of VIVO
ISAR, its latest generation dual drug polymer-free coated stent (DDCS), in
various International markets including Europe.
As an organization, Translumina has always been synonymous with innovation in
the field of intervention cardiology and today's announcement further
strengthens its global cardiovascular portfolio.
Several studies have proven that polymers are pro-inflammatory and may cause
stent thrombosis. However, the use of polymers has been necessary in current
generation DES as they control the release kinetics of the drug by acting as a
carrier for drug loading and release.
VIVO ISAR is the first Dual Drug Polymer-Free Coronary Stent technology, which
brings together a stent with a superior safety profile without compromising the
drug release kinetics. VIVO ISAR is the first technology that uses Probucol, an
antioxidant and lipid-lowering drug, as a carrier for releasing Sirolimus (an
anti-restenotic drug) and thus creates a polymer-free DES platform with
uncompromised safety and efficacy.
In 2020, Translumina became the only company in the world to publish 10-year
follow-up data on its Dual-Drug Polymer-free Coated Stent (DDCS) VIVO ISAR. The
Journal of the American College of Cardiology (JACC), which is amongst the top
publications in the world of cardiology, with a high impact factor as per
Journal Citation Reports, published the 10-year safety and efficacy follow-up
data on VIVO ISAR.
"The ten-year outcome of VIVO ISAR is a major breakthrough in DES technology
as it proves that synthetic polymers can be removed from a DES without
compromising the efficacy of the DES. The excellent safety profile demonstrated
in the 10-year follow-up study is especially notable as it provides a powerful
new technology for treating complex coronary artery disease in high-risk
patient subsets. This DES technology carries the great potential of
significantly shortening the duration of dual antiplatelet therapy," said Dr
Adnan Kastrati, Director, Cardiac Cath Lab, German Heart Center, Munich and the
lead investigator of ISAR TEST 5, the trial that compared VIVO ISAR to
Endeavour Resolute (Medtronic Inc USA).
Patients with diabetes mellitus present a particular challenge as the disease
is associated with a more diffuse manifestation and consequently suboptimal
clinical outcome after percutaneous coronary intervention.
In 2021, the Journal of American Heart Association published compelling
10-year efficacy and safety data of VIVO ISAR in a Diabetes subset highlighting
its excellent efficacy and safety profile, with 30% reduction of MI as compared
to Endeavour Resolute. Translumina became the first company in the world to
achieve the longest RCT follow-up with its flagship Dual Drug Eluting Stent
that brings new hope for the high-risk diabetic subset.
Translumina has launched VIVO ISAR in Italy & Spain and plans to roll it out
in several markets across Europe, Latin America and APAC over the coming
months.
"We are very pleased to be able to provide our premium high-quality stents to
customers across the globe. Cardiologists world over now have a choice to give
a proven and safer Drug Eluting Stent to their patients who otherwise have
poorer outcomes with conventional DES, more so among the high-risk diabetic
subset," said Gurmit Singh Chugh, MD and Co-founder, Translumina.
Everstone Capital invested in Translumina in 2019 to further strengthen its
research & development pipeline, scale its manufacturing operations and expand
its global footprint to transform Translumina into a leading multinational
medical devices company.
"We are proud that Translumina is leading the global journey of creating the
highest standards of clinical data that enable physicians to treat patients
with more confidence and certainty," said Dr. Arjun Oberoi, Managing Director,
Everstone Capital.
About Translumina
Translumina is a global developer and manufacturer of innovative
cardiovascular medical devices used in interventional cardiology. Its flagship
products, YUKON® Choice PC, YUKON® Choice Flex, YUKON® Chrome PC and VIVO ISAR
represent the 3rd generation drug eluting stents systems.
Logo: https://mma.prnewswire.com/media/1797972/Translumina_Logo.jpg
Source: Translumina
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