{"id":51,"date":"2024-09-30T12:29:32","date_gmt":"2024-09-30T12:29:32","guid":{"rendered":"https:\/\/staging.translumina.com\/?page_id=51"},"modified":"2025-07-10T12:11:48","modified_gmt":"2025-07-10T06:41:48","slug":"core-capabilities","status":"publish","type":"page","link":"https:\/\/translumina.com\/in\/core-capabilities\/","title":{"rendered":"Core Capabilities"},"content":{"rendered":"\t\t
\n\t\t\t\t
\n\t\t\t\t\t
\n\t\t
\n\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t
<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t

Core Capabilities<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
\n\t\t\t\t\t
\n\t\t\t\t
\n\t\t\t\n\t\n<\/svg>\t\t<\/div>\n\t\t
\n\t\t
\n\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t
<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t

Comprehensive Excellence in Heart Device Solutions<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t

Our core capabilities encompass every facet of cardiovascular device innovation, from expert manufacturing and cutting-edge clinical research to pioneering R&D, stringent quality control, and thorough regulatory compliance. We are committed to delivering superior heart health solutions through an integrated approach that ensures excellence at every step.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

\n\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t\"\"\n\t\t\t\t\t\t
\n\n\t\t\t\t\t\t\t\t
\n\t\t\t\t\t\t\t\t\t\t\t
<\/div>\n\t\t\t\t\t\t
<\/div>\n\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\n\t\t\t<\/div>\n\n\t\n\t\t\t\t\t\t
\n\n\t\t\t\t\t\t\t\t
\n\t\t\t\t\t\t\t\t\t\t\t
<\/div>\n\t\t\t\t\t\t
<\/div>\n\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\n\t\t\t<\/div>\n\n\t\n\t\t\t\t\t\t
\n\n\t\t\t\t\t\t\t\t
\n\t\t\t\t\t\t\t\t\t\t\t
<\/div>\n\t\t\t\t\t\t
<\/div>\n\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t\t\n\t\t\t<\/div>\n\n\t\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
\n\t\t\t\t\t
\n\t\t
\n\t\t
\n\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t
<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t

Manufacturing<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t

Translumina’s manufacturing combines advanced technology and stringent quality standards to produce world-class cardiovascular devices. Our state-of-the-art facilities support end-to-end production, from precision engineering to rigorous testing, ensuring reliability and safety. With complete process control, we deliver innovative solutions that meet global healthcare demands and enhance patient outcomes.<\/p>

Translumina manufactures Drug eluting stent i.e. Sirolimus Eluting Coronary Stent System (Cobalt Chromium), Sirolimus Eluting Coronary Stent System (Stainless Steel), Polymer Free Sirolimus Eluting Coronary Stent system are already approved under Medical Device Directive 93\/42\/EEC and are under transition phase for certification in EU MDR 745\/2017. Translumina therapeutics LLP registered in EUDAMED and received the Single Registration Number i.e. (SRN)- IN-MF-000011788.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

\n\t\t\t\t
\n\t\t\t\t\t
\"\"<\/figure>

3 facilities covering end-to-end manufacturing for DES & coronary balloons \u2013 specialising in Bare Metal Stents (BMS), Coronary Balloon Catheter, and Drug Coating.\n<\/p><\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

\n\t\t\t\t
\n\t\t\t\t\t
\"\"<\/figure>

3500 m2<\/sup> of floor space across all facilities in India including a 1000 m2<\/sup> clean\nroom.<\/p><\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

\n\t\t\t\t
\n\t\t\t\t\t
\"\"<\/figure>

Highly trained & motivated floor-staff.<\/p><\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

\n\t\t
\n\t\t
\n\t\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t
<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t

Clinical<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
\n\t\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t

Expertise in Global Clinical Trials and Regulatory Compliance<\/strong><\/h4>

Our clinical research department excels in navigating complex global regulatory landscapes, ensuring smooth documentation and compliance across diverse markets. We are committed to sharing our clinical data transparently through registries (CTRI, ClinicalTrials.gov), publishing trial results in reputable journals, and presenting at leading cardiovascular conferences such as TCT, EuroPCR, India Live and NIC.<\/p>

Our Clinical Research Milestones:<\/b><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

\n\t\t\t\t
\n\t\t\t\t\t\t\t
\n\t\t\t
\n\t\t\t\t\t\t\t\t\t\t
\n\t\t\t\t\t\t\t
\n\t\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t
\"\"<\/figure>

Continuous Safety Assessment<\/h4>

Over 15,000 individuals have participated in Translumina\u2019s clinical studies and patient-centric registries to date.\n<\/p><\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t

\n\t\t\t\t\t\t\t
\n\t\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t
\"\"<\/figure>

Proven Clinical Excellence<\/h4>

Our clinical trials and registries are conducted at more than 100 clinical trial sites touching the lives of upto 10,000 patients worldwide.\n<\/p><\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t

\n\t\t\t\t\t\t\t
\n\t\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t
\"\"<\/figure>

Global Outreach<\/h4>

We conduct clinical trials in over 20 countries worldwide.\n<\/p><\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t

\n\t\t\t\t\t\t\t
\n\t\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t
\"\"<\/figure>

Robust Data and Safety Oversight<\/h4>

We are dedicated to disseminating clinical trial information and results via suitable platforms while maintaining the integrity and reliability of our clinical data.\n<\/p><\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t

\n\t\t\t\t<\/path><\/svg>\t\t\t<\/div>\n\t\t\t
\n\t\t\t\t<\/path><\/svg>\t\t\t<\/div>\n\t\t\t\t\t
<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
\n\t\t
\n\t\t
\n\t\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t
<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t

Quality<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
\n\t\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t

At Translumina, quality is central to our innovations. We ensure each cardiovascular device meets the highest standards of safety, precision, and performance, through rigorous testing and strict compliance with global regulations. Our commitment to excellence supports healthcare professionals and provides patients with reliable, life-saving solutions. We advance cardiovascular care with unwavering integrity and dedication.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

\n\t\t\t\t
\n\t\t\t\t\t\t\t
\n\t\t\t
\n\t\t\t\t\t\t\t\t\t\t
\n\t\t\t\t\t\t\t
\n\t\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t
\"\"<\/figure>

Globally Recognized Certifications<\/h4>

Translumina adheres to top industry standards, certified under ISO 13485:2016 and EN ISO 13485:2016. Our products comply with India's Medical Device Regulation 2017 and are manufactured under a Drug Manufacturing license.\n\n<\/p><\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t

\n\t\t\t\t\t\t\t
\n\t\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t
\"\"<\/figure>

Quality Lab & Testing Facilities<\/h4>

All products are rigorously evaluated and tested in our in-house laboratories for mechanical, physiological, and microbial standards, following GLP compliance. This control over processes and components enables us to meet customer requirements efficiently.\n\n<\/p><\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t

\n\t\t\t\t\t\t\t
\n\t\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t
\"\"<\/figure>

Robust Quality Management System (QMS)<\/h4>

Translumina's QMS covers all aspects of design, development, production, storage, and sales of interventional cardiovascular devices, including drug-eluting stents, bare-metal stents, balloon catheters, and vascular access devices.\n<\/p><\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t

\n\t\t\t\t<\/path><\/svg>\t\t\t<\/div>\n\t\t\t
\n\t\t\t\t<\/path><\/svg>\t\t\t<\/div>\n\t\t\t\t\t
<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
\n\t\t
\n\t\t
\n\t\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t
<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t

Research & Development<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
\n\t\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t

Translumina Therapeutics R&D department is a global innovation hub, dedicated to revolutionizing cardiovascular care.<\/strong><\/h4>

Our world-class research centers in India, Germany, and the Netherlands bring together a diverse team of passionate experts in biomedical engineering, material science, drug delivery, and pharmacodynamics. This dynamic collaboration fosters the development of cutting-edge cardiovascular technologies, including next-generation stents, cardiovascular balloons, drug-eluting balloons, and heart valve solutions. By partnering with renowned institutions like the German Heart Center, we translate groundbreaking research into advanced medical devices that enhance patient outcomes and improve lives worldwide.<\/p>

Our global reach and diverse expertise enable us to:<\/strong><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

\n\t\t\t\t
\n\t\t\t\t\t\t\t
\n\t\t\t
\n\t\t\t\t\t\t\t\t\t\t
\n\t\t\t\t\t\t\t
\n\t\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t
\"\"<\/figure>

Drive innovation<\/h4>

Our team of skilled professionals leverages advanced technologies and methodologies to develop groundbreaking solutions.\nPrioritize patient needs: Our patient-centric approach ensures that our products <\/p><\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t

\n\t\t\t\t\t\t\t
\n\t\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t
\"\"<\/figure>

Prioritize patient needs<\/h4>

Our patient-centric approach ensures that our products address real-world challenges and improve quality of life.\n<\/p><\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t

\n\t\t\t\t\t\t\t
\n\t\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t
\"\"<\/figure>

Adhere to rigorous standards<\/h4>

We are committed to the highest standards of regulatory compliance, ensuring the safety and efficacy of our products.\n<\/p><\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t

\n\t\t\t\t<\/path><\/svg>\t\t\t<\/div>\n\t\t\t
\n\t\t\t\t<\/path><\/svg>\t\t\t<\/div>\n\t\t\t\t\t
<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t

By combining scientific excellence with a deep understanding of clinical needs, Translumina Therapeutics is shaping the future of cardiovascular care.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

\n\t\t\t\t
\n\t\t\t\n\t\n<\/svg>\t\t<\/div>\n\t\t
\n\t\t
\n\t\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t
<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t

Regulatory<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
\n\t\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t

The Regulatory Affairs department at Translumina is dedicated to ensuring our medical devices meet the highest global regulatory standards, prioritizing safety and efficacy in every market we serve. Recognizing the importance of compliance in delivering trusted, life-enhancing solutions, we remain closely aligned with evolving regulatory guidelines.<\/p>

Our team brings extensive expertise in securing product registrations across key regions, including Europe, APAC, the Middle East, Africa, Latin America, and CIS countries. This global proficiency allows us to navigate complex regulatory landscapes effectively, ensuring our devices meet all standards for quality and patient safety.<\/p>

With a proven track record in regulatory compliance, we are committed to bringing our innovative cardiovascular devices to market efficiently and responsibly. This commitment enhances patient outcomes worldwide and strengthens the trust healthcare professionals place in Translumina products.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"

Core Capabilities Comprehensive Excellence in Heart Device Solutions Our core capabilities encompass every facet of cardiovascular device innovation, from expert manufacturing and cutting-edge clinical research to pioneering R&D, stringent quality control, and thorough regulatory compliance. We are committed to delivering superior heart health solutions through an integrated approach that ensures excellence at every step. Manufacturing […]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-51","page","type-page","status-publish","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/translumina.com\/in\/wp-json\/wp\/v2\/pages\/51","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/translumina.com\/in\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/translumina.com\/in\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/translumina.com\/in\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/translumina.com\/in\/wp-json\/wp\/v2\/comments?post=51"}],"version-history":[{"count":585,"href":"https:\/\/translumina.com\/in\/wp-json\/wp\/v2\/pages\/51\/revisions"}],"predecessor-version":[{"id":12308,"href":"https:\/\/translumina.com\/in\/wp-json\/wp\/v2\/pages\/51\/revisions\/12308"}],"wp:attachment":[{"href":"https:\/\/translumina.com\/in\/wp-json\/wp\/v2\/media?parent=51"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}