When it was reported that thrombosis occurred in the Absorb

“I think Absorb has dampened the enthusiasm for companies,” Sripal Bangalore, a cardiologist at New York University who has done clinical trials for Abbott, said. “It’s still a lot of investment to kind of fine-tune this technology. But I’m hoping that other companies with thinner scaffolds will have favorable results.”

Abbott, too, is working on a second-generation dissolving stent.

“We pioneered bioresorbable technology because we believe it offers patients the possibility of life without permanent metallic implants, and we will continue to work on a next-generation bioresorbable device,” an Abbott spokesperson said.

Clinical trial economics

Soon after Absorb’s launch in India, Meril applied for a World Intellectual Property Organisation (WO) patent for MeRes100. In 2015, they began a clinical trial that had a one year follow up. Before the trial results were formally published, they received approval from the Indian health ministry to sell the stents commercially.

Meril claims that its stent is better than Abbott’s because of several improvements, the most important being that its stent is thinner, at about 100 microns, compared to Abbott’s 154-micron device.

But some negatives remain. A doctor would need to deploy MeRes100 with as much care as an Absorb. And a recent study found that the material used in disappearing stents may have caused the issues noted in Absorb, a fact that has not been accounted for in MeRes100.

Kaul, the cardiologist, has participated in both Absorb and MeRes100 clinical trials and said the latter is not yet proven. In the first MeRes100 clinical trial, Indian cardiologists implanted the device in 108 select patients and followed them for six months to a year.

A second study had 64 patients. Given that most of Absorb’s problems became visible only after more than two years of follow up of patients and millions of data points, Meril’s studies are insufficient.

Difficulties on the first trial

“It may be difficult to find signals in one clinical trial,” said Bangalore of NYU. “You really need to look at multiple different clinical trials and the trials have to be well powered to see the signal of worst outcomes.”

But instead of plowing forward, Meril has dialed back, Tripathy of Meril said. One reason is that there is no market pressure at the moment.

“Now, there is not a big company selling any bioresorbable stent, so they don’t have pressure to put it in the market so quickly,” said Alexandre Abizaid, a cardiologist at Instituto Dante Pazzanese de Cardiologia (IDPC) in Brazil, who worked on Meril’s imaging study. “So they are going to take it a bit more slowly.”

Another reason is the Indian government’s 2017 price cap on stents, which dashed Meril’s plans of selling MeRes100 for about Rs 80,000 ($1,110). The government mandates a price of Rs 29,600 ($410). The company has met multiple times with government officials, arguing their technology is unique, a “Make in India” success story, and qualifies for a price cap exemption.

Their entreaties have fallen on deaf ears, Tripathy said. “These guys are not understanding, they are somewhat adamant and that’s why we are not able to launch [MeRes100] technology in the country,” he said.

The next step for Meril would be a larger trial that shows that the stent is better than drug-coated metallic stents, like Xience. For this, it would need to implant the stent in thousands of patients. Stent implantation and clinical trial follow up studies cost Rs 10 lakh ($13,800) or more per patient, depending on the country, according to Tripathy of Meril.

If Meril implants MeRes100 in 2,000 patients, similar to the size of Abbott’s clinical trials, it would cost the company Rs 200 crore ($27.7 million). If they implant a comparison stent, such as Xience, their costs would double. That’d be 16 times Meril’s R&D budget in 2017.

In order to justify the further clinical trial expenses, Meril needs to make money from MeRes100, Tripathy said. And for that, it needs a price cap exemption.

Old is gold

Meril’s not the only device manufacturer facing this Catch22. Clinical trials are so expensive that results from the first well-powered trial, comparable to that of a pharmaceutical giant like Abbott, by an Indian stent manufacturer was released only this week.

 

 

 

 

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