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Investigational balloon gets reimbursement

This article was originally published in Clinica

Executive Summary

Medicare patients participating in the Barath cutting balloon trial will receive reimbursement, following investigational device classification by the US FDA. The angioplasty balloon, which is manufactured by Interventional Technologies (US), has been classified as a category B investigational device, ie. a Class III device with technological advances compared to a PMA-approved device. The cutting balloon trial includes 1,250 patients at 30 centres worldwide.

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