Hyderabad: Interventional cardiologists have sought further studies on the controversial bioresorbable vascular scaffold stents following a medical device alert issued by the Central Drugs Standards Control Organisation.
The CDSCO had earloer permitted import of the stents which dissolve into the body. Following restrictions on their use in Europe and recall in the US, the CDSCO said that three years clinical data from Absorb II revealed an elevated rate of major adverse cardiac events like myocardial infarction and scaffold thrombosis.
Consultant interventional cardiologist Dr G. Ramesh “According to Absorb 3 trial data the risk of thrombosis is more in BVS stents than that third generation stents. But the concept of BVS is good and has a future. BVS stents were used widely in India too, particularly in New Delhi, but are being discouraged now. Indian researchers are working on this and hope we get to make a better stent.”
The Drug Controller General of India has been evaluating the safety data submitted by the US-based company Abbott which makes these stents and CDSCO is stressing on additional studies on safety in Indian patients.