A Milestone
in Cardiology and Made-in-India Innovation
In what can be termed a landmark moment for
both Indian healthcare and medical device manufacturing, the next-generation
Indian heart stent Supraflex Cruz has achieved global recognition by
outperforming a US-made industry leader in a major clinical trial. The results
of the trial named TUXEDO‑2 were presented by Dr Upendra Kaul at an
international cardiology conference. The trial compared Supraflex Cruz with the
established US device Xience in a high-risk patient population, demonstrating
that the Indian-manufactured stent was non-inferior, and indeed showed a lower
failure rate in some measures.
The Trial:
Design, Population and Results
The TUXEDO-2 study was conducted across 66
leading cardiology centres in India and focused on a high-risk cohort patients
with diabetes and multivessel coronary artery disease. According to Dr Kaul,
about 80% of participants had triple-vessel disease.
The primary endpoint was Target Lesion
Failure (TLF) at one year a composite of cardiac death, target-vessel
myocardial infarction (MI), or need for clinically-driven repeat procedures.
The results showed that Supraflex Cruz achieved comparable outcomes to Xience,
and in fact a numerically lower TLF rate.
For example, according to the Express
Healthcare summary, the platform showed a low rate of clinically-driven target
lesion revascularisation (2.1%) and very low stent-thrombosis rate (0.8%) at
one year in real-world registries reinforcing safety and efficacy.
Why This
Matters: Innovation, Local Manufacturing and Global Impact
The success of Supraflex Cruz signals several
important trends:
Technological maturity of Indian manufacturing: The stent
is made in Surat by Sahajanand Medical Technologies (SMT) and its performance
against a globally-recognised device elevates India’s device-innovation
profile.
Addressing a high-risk subset: Diabetic
patients with multivessel disease are statistically more likely to experience
restenosis or thrombosis post-PCI so showing non-inferiority in this group is
especially meaningful.
‘Make in India’ relevance and export potential: With such
strong outcomes, Indian-made devices may find broader acceptance domestically
and internationally, reducing dependence on imports.
Clinical confidence and competitive edge:
Cardiologists may more freely choose Indian platforms given robust evidence,
potentially reducing costs and broadening access to advanced interventions.
Device and
Technology Features
Supraflex Cruz represents a next-generation biodegradable-polymer,
ultra-thin-strut, drug-eluting stent (DES). The biodegradable polymer
degrades over time, leaving behind a neutral scaffold, thereby potentially
reducing long-term complications compared to durable polymer stents.
By contrast, legacy stents like Xience use
durable-polymer everolimus-eluting technology. In the TUXEDO-2 trial, SMT’s
ultra-thin strut technology was pitted against the durable-polymer competitor
and found to be non-inferior—offering interventionalists a strong alternative.
Implications
for Patients, Practitioners and Industry
For patients, the implications are hopeful:
access to high-performance stents at potentially lower cost may broaden
treatment of complex coronary disease. For cardiologists and practitioners, the
availability of robust data means greater confidence in selection of stents for
challenging populations.
For the medical device industry, the success
of an Indian-built stent of global-quality performance could spur more
investment, innovation and export ambitions. It may also stimulate more trials
and regulatory recognition for Indian medical devices.
Looking
Ahead: Challenges and Next Steps
While the results are promising, some caveats
and future steps remain:
Long-term outcomes: Although
1-year data are strong, long-term (3-5 years) data will further validate
durability, thrombosis rates and clinical utility.
Wider generalisability: Although
TUXEDO-2 focused on high-risk Indian patients, data in other populations or
geographies would bolster global acceptance.
Cost and access: Ensuring
that cost-benefit translates into broader access in India’s diverse healthcare
ecosystem remains a practical challenge.
Regulatory and global approval: Exporting
devices requires regulatory approvals in many countries SMT will need to
navigate these to scale globally.
Continuous innovation: The
device-industry cycle demands ongoing product upgrades ultra-thin struts, novel
polymers, bioresorbables so competition remains.
Conclusion
The achievement of the TUXEDO-2 trial showing
the Indian-manufactured Supraflex Cruz stent performing at least as well as a
US-based global market leader in a very high-risk population is a landmark
moment. It not only highlights Indian clinical and manufacturing competence but
also opens doors for greater self-reliance in high-tech healthcare devices and
global export potential. As the healthcare landscape evolves, such innovations
will play a critical role in advancing patient outcomes, reducing costs and
improving access both in India and globally.
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