Largest-selling stent in India has been banned in Europe

Bioresorbable stents have effectively been pulled from the European market and will now be available only in "clinical registry setting at select sites/institutions" in Europe, where they will be monitored till a review in 2018. India has been among the largest markets for these stents in recent years.

Asked if these stents would be restricted to specific sites in India too, Abbott told TOI it has notified the Drug Controller General of India that post-marketing registries are being initiated in Europe to monitor implantation technique.

The development comes in the wake of several studies showing that bioresorbable cardiac stents are not only not superior to existing drug eluting stents (DES), but might even have worse outcomes in some ways.

"No further BVS (bioresorbable vascular scaffolding) stents will be provided to non-registry sites after 31st march 2017 and these sites have been instructed to cease implants and existing inventory will be removed," stated an advisory from Abbott, which is "working jointly with the European Regulatory Agencies" to address concerns of increased risk of stent thrombosis and longer duration of use of blood thinners for those implanted with BVS compared to those with DES. These were the risks the studies had highlighted.

Abbott India's response to TOI's questions while reiterating its claims about the BVS, said "the objective of the EU registries is similar to post-approval observational studies and training being conducted in other parts of the world to confirm the effect of current implantation technique on clinical outcomes."

BVS used to cost Rs 2 lakh in India before price control, considerably higher than other stents. The stent industry had argued, with support from many cardiologists, that it should be outside price control as it was "the latest generation stent".

However, a panel of 17 cardiologists from top government institutions pointed out in a report that no study in the world had proven BVS to be superior to DES.
Eminent cardiologists from private hospitals nevertheless wrote articles and appeared on television to expound on the superiority of the BVS and to say it should be outside price control.

The first biodegradable stent implant in Asia was done in 2010 in Fortis Escorts Hospital in Delhi by Dr Ashok Seth as part of a trial.

In September 2012, Abbott announced the launch of its BVS called Absorb and claimed that the "world's first drug eluting bioresorbable vascular scaffold has the potential to revolutionize treatment of coronary disease".

Absorb was introduced in India in December that year after clinical trials on 100 patients.

Data from the Cardiology Society of India showed that in 2013, about 8,500 bioresorbable stents were used in India. This was despite their much higher cost. Indian cardiologists took to this new stent so enthusiastically that India became one of the largest markets for Absorb in 2014.

Dr Seth, who in July 2014 said he had used over 800 such stents in 18 months supported it saying: "If I needed a stent, it would be a bio-absorbable one." India accounted for a third of Abbott's $132 million global revenues in 2014 from bioresorbable stents.

Asked for his reaction to the latest development, Dr Seth told TOI: "The BVS has been available in India post submission of clinical data of Indian patients and DCGI approval and is currently used in a very small proportion of Indian patients.

At Fortis, less than 10% patients have received the BVS since its approval."

He said the technology "had the potential to be of great benefit to patients of coronary artery disease especially as it does not leave any permanent metal implant in the coronary arteries in the long term".