Latest news with #ConceptMedical
Time of India
a day ago
- Health
- Time of India
Study evaluating efficacy of Sirolimus-Coated Balloon against Drug-eluting Stent completes patient enrollment
Cleveland: An Italy-based research foundation, the Lodi has announced the completion of patient enrolment for a trial evaluating the safety and effectiveness of Sirolimus-Coated Balloon (SCB) in comparison with the Drug-eluting Stents. The trial has enrolled a total of 1,832 patients from Europe, Asia, and South America and designed to evaluate the safety and effectiveness of the MagicTouch Sirolimus-Coated Balloon (SCB) in comparison with the Everolimus-Eluting Stent (EES) in patients with De-Novo Coronary Artery Disease . 'After 3 and half years, we were able to complete the enrolment in TRANSFORM II trial , a study that involved 52 centers across 3 continents and will test this Sirolimus DCB with the most studied and used DES, in a daily patient population,' said Dr Bernardo Cortese, the Study Chairman. The head-to-head comparison is undertaken to determine whether drug-coated balloon technology can be widely adopted for primary treatment of small coronary lesions—which currently accounts for nearly 80 per cent of all Percutaneous Coronary Interventions . Developed by Concept Medical in delivers sub-micron particles of sirolimus encapsulated in a biocompatible carrier, ensuring deep penetration into the vessel wall. The device has obtained Breakthrough Device Designation from the US FDA for the treatment of small coronary vessels and in-stent restenosis.
Time of India
16-05-2025
- Health
- Time of India
Concept Medical wins Times Healthcare Leaders 2025 award for innovation excellence
Concept Medical Group, a global leader in drug-eluting technologies , has been awarded the prestigious Times Healthcare Leaders Award 2025 for the 'Excellence in Healthcare Innovation – Medical Device & Technology' category. The accolade, presented by the Times of India Group, recognises the Company's transformative contribution to cardiovascular intervention through the development of the world's first Sirolimus-Coated Balloon (SCB). This breakthrough has enabled a metal-less form of angioplasty, representing a paradigm shift in cardiac care by offering a safer, more effective alternative to conventional stent-based treatments for vascular diseases . Concept Medical's innovation has significantly benefited patients worldwide, especially those at high risk from permanent metal implants. 'This recognition reaffirms our core belief that meaningful innovation in healthcare begins with a deep understanding of patient needs and scientific rigor,' said DrManish Doshi, Founder and Managing Director, Concept Medical Group. 'The Sirolimus-Coated Balloon is not just a technological advancement — it's a global solution to safer angioplasty, developed with a mission to improve patient outcomes and reduce restenosis.' The award was received by Dr. Pankaj Gandhi, Chief Research Officer ,Concept Medical and one of the key scientific architects behind the Company's local drug delivery platforms. With multiple national and international patents to his name, Dr. Gandhi has published extensively in global journals and has been the core member of the R&D team of Drug Eluting Stents (DES) and Drug Coated Balloons (DCB), led by Dr. Manish Doshi, that now forms the backbone of Concept Medical's product portfolio. Known for his scientific depth and innovative mindset, he continues to spearhead disruptive product development in vascular therapies. Redefining Interventional Therapies Globally Concept Medical, headquartered in the USA with its manufacturing arm in India, and operations in more than 80 countries, is widely recognized for its specialization in advanced drug-coated balloons and stents across coronary, peripheral, and dialysis access indications. The company has received multiple FDA Breakthrough device designations, followed by five IDE approvals by the USFDA, a distinction awarded to medical devices that offer significant advantages over existing therapies. Backed by a strong clinical research engine, Concept Medical is currently engaged in over 50 global clinical trials, positioning itself at the forefront of evidence-based medical innovation. The Company's mission is rooted in making next-generation drug delivery devices accessible worldwide and transforming patient care through safe and effective drug delivery technologies. The Times Healthcare Leaders Awards, organized annually by the Times of India Group, celebrates organisations and individuals that are driving innovation, advancing medical research, and improving healthcare delivery in India. The awards bring together influential voices and changemakers to spotlight excellence in the country's healthcare ecosystem. With this recognition, Concept Medical further strengthens its reputation as a pioneer in the drug delivery device industry, committed to reshaping the landscape of vascular treatment with cutting-edge, patient-centric solutions. Disclaimer - The above content is non-editorial, and ET Healthworld hereby disclaims any and all warranties, expressed or implied, relating to it, and does not guarantee, vouch for or necessarily endorse any of the content.
