Made in India new generation heart stent receives major global recognition
PTI October 31, 2025 06:40 AM
Synopsis

An Indian-made heart stent, Supraflex Cruz, has demonstrated a lower failure rate in high-risk patients compared to a US-made market leader. The TUXEDO-2 trial, conducted in India, showed the Indian stent to be non-inferior and resulted in significantly lower Target Lesion Failures, including cardiac death and heart attacks.

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An Indian medical innovation has achieved a major global recognition with a new generation heart stent manufactured in India achieving a lower failure rate in high-risk patients against a US-made international market leader.

At a largely attended global conference of cardiologists, which concluded on Wednesday, well-known Indian heart specialist, Dr Upendra Kaul, Chairman and Dean of Delhi's Batra Hospital, presented the results of a trial in India named TUXEDO-2, which rigorously compared the new generation Indian-made heart stent, Supraflex Cruz, against the international market leader Xience of the USA.

Conducted across 66 Indian cardiology centres, the trial focused specifically on a highly complex patient population, such as patients with diabetes and advanced multi-vessel disease. Eighty per cent of the participants had triple vessel disease, according to Dr Kaul, under whose leadership the trial was conducted.


The results were overwhelmingly positive for the Indian device, demonstrating that Supraflex Cruz was non-inferior to the established international standard.

The data revealed that the Indian stent resulted in a remarkable lower Target Lesion Fail (TLF), which measures serious outcomes including cardiac death, target vessel myocardial infarction (MI) and need for a clinically-driven repeat procedure.

Dr Kaul said that the Indian stent, manufactured by a company in Surat, additionally showed a numerically lower rate of heart attacks in one year.

The results were commended at the conference as an example of the technical excellence of Indian medical device manufacturing, Dr Kaul said.

The trial was successfully executed under the leadership of Dr Kaul, Co-Chairman Dr Sripal Bangalore, and Project Director Dr Priyadarshini Arambam.
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