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