Indian stent-maker SMT or Sahajanand Medical Technologies has said it was ready to make its new and “highly deliverable” version of the Supraflex drug-eluting stent commercially available in Europe from Thursday.

This development comes after the Supraflex Cruz received the approval (CE mark) from the European regulatory recently . In fact, a little less than a year ago, a study in Europe found that the Supraflex stent system could be compared to Abbott’s Xience stent.

The stent only involved a change in design, making it more deliverable and thus “substantially” reducing procedure time for doctors and patients, SMT Chief Executive Ganesh Sabat told BusinessLine.

Supraflex Cruz is a Sirolimus eluting stent built on a Cobalt Chromium Platform and has been implanted in more than 2,50,000 patients in select Indian centres and certain international markets over the last three years. “The drug and polymer have not been changed,” he said. The company is also looking to increase the availability of the new product in India as well.

Stents are wire-like products used to unclog arteries. Deploying a stent can be difficult if the arteries are highly calcified or present in a location that was too deep, said Sabat, adding that companies were constantly innovating on design to make their stents easily deliverable.

The new product would find acceptance in Europe, he explained, because of an elderly population who may have more complicated arteries and who would not be able to spend too much time in an operation theatre.

India, beyond price control

“The Gujarat-based company had also started discussions with Indian hospitals, even as the price of stents have been capped by the Government at about Rs 30,000 odd,” said Sabat.

“We are not averse to bringing our best innovation to India even with the price cap,” he said.” He was referring to multi-national companies who have discontinued or said that price controls inhibited them from brining their best products into the Indian market.

Between price control, the Centre’s Ayushman Bharat health insurance programme and the increase in the number of cath-labs in the country, the access to stents has improved, he said.

Citing industry data, he added that last year about 230 new cath-labs were set-up across the countryincluding Uttar Pradesh, Jammu and Kashmir and the North-East.

While pricing dominates the conversation around stents in India, Sabat clarified that his pitch in Europe was not of being a “low-cost” stent but a competent, quality product with scientific results comparable to the best in class. “We are not going to start a price war,” he said, adding that they were open to discussions if Government of other health systems wanted to procure the product from them.

Further clinical studies on Cruz are planned across Europe, India, Latin America and rest of the world over the next two years, SMT said. There were to test Supraflex Cruz in a “challenging patient population” including diabetics, high-bleeding risk patients and fragile patients aged over 75years, the company said.

Related Topics