Attention Cardiologists: Please Report adverse events related to Abbott's BVS stents to CDSCO

Patients and healthcare professionals are advised to report adverse events suspected to be associated with the use of Absorb Bioresorbable Vascular Scaffold (BVS) and Absorb GTl Bioresorbable Vascular Scaffold (BVS) to the manufacturer, Importer and CDSCO.

New Delhi: Central Drugs Standard Control Organization(CDSCO) issued safety alert on Abbott's Bioresorbable stents, while asking healthcare professionals and patients to report adverse effects.

This comes after reports of the European health authority's move to ban the Abbott's Bioresorbable stents in European market except selected registries rocked the Indian Market. The Indian Health Ministry has issued a medical alert, where the Ministry has directed the patients and doctors both to report the adverse effect of Abbott's Bioresorbable stent to Central Drugs Standard Control Organization (CDSCO).

According to the past data, India has been among the largest markets for these stents in recent years.

Medical Dialogues earlier reported that last week, the European health authorities has issued a notice notifying that Abbott's stents will 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.

Read also: Abbott’s Bioresorbable stents Banned in European Market, Still used in India!

The Central Drugs Standard Control Organization (CDSCO) has posted on its official website stating that," The Indian agent M/s Abbott Healthcare Pvt. Ltd., has informed this office that the manufacturer has initiated a Field Safety Notice in European countries to communicate that product use will' be limited to established post-market registries to facilitate the collection of real-world evidence for Absorb BVSand Absorb GTl BVSsystems."

"The registries will capture data from the implantation of all sizes of Absorb Bioresorbable Vascular Scaffold (BVS) and Absorb GTl Bioresorbable Vascular Scaffold (BVS) in the European market."

“Based on the three year clinical data analysis from ABSORB 11, it has been observed that there is an over elevated rate of major adverse cardiac events, specifically myocardial infarction and scaffold thrombosis,” stated the Drug Controller General of India.

"Patients and healthcare professionals are advised to report adverse events suspected to be associated with the use of Absorb Bioresorbable Vascular Scaffold (BVS) and Absorb GTl Bioresorbable Vascular Scaffold (BVS) to the manufacturer, Importer and CDSCO," the alert added

A senior CDSCO official, though, clarified to TOI that "this isn't a ban or restriction on use, it is merely a cautionary exercise".

Following Notice contains the details of the alert