The Hindu Business Line : Johnson & Johnson allays safety concerns on `withdrawn' stent

Snapshot
The stent CoStar II is a product from Conor Medsystems LLC. But it came under the J&J umbrella following its acquisition of Conor in February this year.
Stents are thin steel wires inserted into blood vessels to remove blockages and drug-coated stents prevent the blockages from recurring.

Mumbai May 10 With about 3,000 CoStar II stents sold in India, Johnson & Johnson (J&J) has sought to allay fears of patients who may have had the recently "withdrawn" drug-coated heart stent used in them.

It is not a recall, but a voluntary decision to withdraw the CoStar II stent, as the product failed to meet the objective of a pivotal study, a J&J source told Business Line. There were no safety concerns on the product and the withdrawal was related to the efficacy of the product, the official added.

J&J's global communication following the withdrawal said, the trial did not identify safety issues and the rates of death, myocardial infarction and stent thrombosis were consistent with observations in other stent-related studies.

Conor's product

CoStar II is a product from Conor Medsystems LLC. But it came under the J&J umbrella following its acquisition of Conor in February this year. The J&J official pointed out that the product licence on CoStar II still lies with Conor.

Stents are thin steel wires inserted into blood vessels to remove blockages and drug-coated stents prevent the blockages from recurring. They have been widely used by doctors in India, despite the product costing about Rs 1 lakh to a patient.

Conor's local distributors are Mumbai-based Interventional Technologies. And the Mumbai-based company has responded to the regulator, the Drug Controller General of India's queries on the product withdrawal, said a source familiar with the development. Sale of the product has been discontinued in several markets, including India.

`Details needed'

With hospitals being apprised of the withdrawal, doctors would be required to get in touch with the patients on whom the stent has been used or the patients concerned should get in touch with their cardiologists, the source said.

A reputed doctor with a leading Mumbai-based hospital told Business Line that the use of the CoStar II stent has been stopped. But doctors are still to get a clear picture on the precise nature of the problem.

Though safety did not seem to be the concern behind the product withdrawal, the doctor reserved his judgment till more details were provided by the company. With superior efficacy of the particular stent being in question, putting such a product in a patient is equally worrisome, given the high price of stents, he observed.