SCTIMST unveils Chitra Core, its first coronary stent
The Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST), Thiruvananthapuram, has unveiled its first indigenously developed coronary stent, named Chitra Core.
The device is designed to reduce stent-related complications such as restenosis (re-narrowing of the treated artery) and thrombosis (clot formation on the stent).
Its patented design reportedly uses 30-40% less metal than conventional coronary stents, aimed at lowering the metal burden left inside the artery while maintaining mechanical support.
The stent adds to SCTIMST's portfolio of indigenous cardiovascular devices developed through its Biomedical Technology Wing, which has previously commercialised devices such as the TTK Chitra Heart Valve.
Coronary Stents: Types and the Restenosis/Thrombosis Problem
A coronary stent is a small mesh tube inserted during angioplasty to hold open a narrowed or blocked coronary artery. Stent technology has evolved through three broad generations: bare-metal stents (BMS), drug-eluting stents (DES) that release anti-proliferative drugs (such as everolimus or sirolimus) to prevent tissue overgrowth, and bioresorbable/biodegradable stents that dissolve over time. The two major long-term complications are in-stent restenosis (renewed narrowing due to neointimal tissue growth, typically 3-6 months post-implantation) and stent thrombosis (clot formation on the stent surface, which can occur from 1 month to over a year after implantation).
Key Details
- Bare-metal stents reduced acute vessel recoil compared to plain balloon angioplasty but carried higher restenosis rates than later-generation stents.
- Drug-eluting stents significantly lowered restenosis and target-vessel revascularisation rates compared to bare-metal stents but require longer dual antiplatelet therapy due to delayed vessel healing.
- Reducing the metal "footprint" of a stent (thinner struts, less metal surface area) is a recognised design strategy to lower the vessel-wall injury and inflammatory response that trigger restenosis and thrombosis.
Chitra Core's stated 30-40% reduction in metal content directly targets this design lever, aiming to lower the biological triggers for restenosis and thrombosis rather than relying solely on drug coatings.
SCTIMST: Institutional Profile
SCTIMST is an Institute of National Importance, established through gifting of a building by the erstwhile Maharajah of Travancore in 1973 and elevated to national-importance status by an Act of Parliament in 1980. It functions as an autonomous institute under the Department of Science and Technology (formerly Department of Health Research linkage for its hospital wing), Government of India, and has three constituent wings: a tertiary-care super-specialty hospital, a Biomedical Technology Wing, and the Achutha Menon Centre for Health Science Studies.
Key Details
- SCTIMST's Biomedical Technology Wing has a track record of low-cost indigenous cardiovascular device development, most notably the TTK Chitra Heart Valve, licensed to TTK Healthcare and implanted in an estimated 200,000-plus patients, noted for its low cost and low failure rate.
- The institute also has ongoing programmes for indigenous prosthetic heart valves, ASD (atrial septal defect) occluders, aortic stent grafts, and flow-diverter stents, positioning Chitra Core within a broader indigenisation push in cardiovascular devices.
- As a DST-affiliated Institute of National Importance, SCTIMST combines patient care, research, and technology transfer to industry partners for commercial-scale manufacturing.
Chitra Core follows the same technology-transfer model that produced the Chitra Heart Valve — indigenous R&D at a public institute, patented locally, then transferred to industry for affordable domestic manufacturing, reducing reliance on imported cardiovascular devices.
Medical Device Regulation in India
Coronary stents are regulated as medical devices under the Medical Devices Rules, 2017, notified under the Drugs and Cosmetics Act, 1940, and enforced by the Central Drugs Standard Control Organisation (CDSCO) under the Drugs Controller General of India (DCGI). Devices are classified by risk into Class A (low), B (low-moderate), C (moderate-high), and Class D (high risk); coronary stents, along with cardiac pacemakers and heart valves, fall in the high-risk Class D category requiring the most stringent approval pathway.
Key Details
- Class D devices require clinical evidence and DCGI approval before manufacture, sale, or import in India.
- The Medical Devices Rules, 2017 follow a globally harmonised, risk-based classification approach (aligned with the Global Harmonization Task Force framework).
- Domestic manufacture of Class D cardiovascular implants under India's "Make in India" push is also supported through production-linked and medical-device-park incentives administered separately by the Ministry of Chemicals and Fertilizers.
As a high-risk implantable device, Chitra Core will need to clear Class D regulatory approval and clinical evaluation via CDSCO before wider clinical rollout, a step distinct from the institute's own R&D and patenting process.
- Chitra Core is SCTIMST's first coronary stent, developed by its Biomedical Technology Wing in Thiruvananthapuram, Kerala.
- The stent uses a patented design with 30-40% less metal than conventional coronary stents, aimed at reducing restenosis and thrombosis risk.
- SCTIMST was declared an Institute of National Importance by an Act of Parliament in 1980 and functions under the Department of Science and Technology.
- Coronary stents are classified as Class D (high-risk) medical devices under the Medical Devices Rules, 2017, regulated by CDSCO/DCGI.
- SCTIMST's earlier indigenous device, the TTK Chitra Heart Valve, has been implanted in an estimated 200,000-plus patients worldwide.