Bioresorbable stents withdrawn from European markets, to be available only in clinical registries

Bioresorbable stents (these stents gradually resorb and are benignly cleared from the body, leaving no permanent implant) had been withdrawn from the European market and would now be available only in "clinical registry setting at select sites / institutions" in Europe, where they will be monitored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 the stents in recent years.

Abbott, which introduced its bioresorbable vascular scaffolding stents (BVS) Absorb, in India, told The Times of India that it had notified the Drug Controller General of India that post-marketing registries were being initiated in Europe to monitor implantation technique.

The development comes after studies showed that bioresorbable cardiac stents were not only not superior to existing drug eluting stents (DES), but their use 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 as against those with drug eluting stent (DES).

Meanwhile, it has been found in its most recent clinical trial, published in New England Journal of Medicine (NEJM) that Absorb was tied to an increased risk of device thrombosis - a dangerous side effect where a blood clot formed on the stent itself.

While thrombosis formed in only eight patients with a drug-eluting stent, it occurred in 31 patients who had an Absorb implant.

In his review of the study, Dr Debabrata Mukherjee, MD and chief of cardiovascular medicine at Texas Tech University Health Sciences Center in El Paso, Texas, writes, "Because the current generation of metallic drug-eluting stents is associated with excellent outcomes, there is little rationale to use bioresorbable vascular scaffolds at this time."

"Bioresorbable stents cost more than the typical metallic stent and they take longer for cardiologists to insert," he further explains. "They are also no more effective, and less safe. As a physician, why I am going to use something that costs me more if it can cause risk or harm to my patients?''