Before Ceiling the said stent used to cost Rs 2 lakh approximately and was propogated heavily by the company as NEXT Gen Stent
Abbott’s bioresorbable stents will no more be seen in regular European centres and will now be available only in“clinical registry setting at select sites/institutions in Europe,” as the European authorities seem to have caste doubts on the safety and the efficacy of these new class of stents.
A report in TOI points that the stents have been pulled out of the european market barring the few centres and will be monitored by the European authorities till a review in 2018. Ironically, in India the said Stents still continue to be in large use.
Speaking over the authorities move an advisory from Abbott said, “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.” The official furhter added that they are “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
The move comes after several studies which shown that bioresorbable cardiac stents are not only not superior to existing drug eluting stents (DES), but might even have worse outcomes in some ways.
Medical Dialogues team earlier reported that after two years marketing of Abbott’s bioresorbable stents studies have found that After two years in the trial, called Absorb III, 10.9 percent of Absorb patients had experienced target lesion failure, versus 7.9 percent of those in the Xience group, a statistically significant difference.
TLF is defined as a combination of heart-related death, heart attack related to the treated vessel and need for repeat procedure due to reclogging of the treated part of the artery. The result was driven by a higher rate of target vessel heart attacks – 7.3 percent versus 4.9 percent for Xience.
The difference between the two stents declined and was no longer statistically significant when the smaller-vessel patients were excluded, researchers said.
Largest Sale in India
When the media asked the Abbott about the restricted use of bioresorbable stents in India market as India is the largest user of Abbott’s stents in recent years, Abbott officials said that it has notified the Drug Controller General of India that post-marketing registries are being initiated in Europe to monitor implantation technique.
Abbott announced the launch of its BVS stents in September 2012 and claimed that the “world’s first drug eluting bioresorbable vascular scaffold has the potential to revolutionize treatment of coronary disease”.It was launched in India in December after after clinical trials on 100 patients.
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.”
Before ceiling on the price of stents, BVS stents at approximately Rs 2 lakhs would cost more than 3-4 times the cost of DES stents. Data from the Cardiology Society of India showed that in 2013, about 8,500 bioresorbable stents were used in India.