Terumo Aortic’s Thoraflex Hybrid Device Receives CMS Approval for New Technology Add-On Payment

October 3, 2022—Terumo Aortic announced that the United States Centers for Medicare & Medicaid Services (CMS) has granted approval of a new technology add-on payment (NTAP) for the company’s Thoraflex Hybrid device, used in frozen elephant trunk (FET) repair, under the CMS Inpatient Prospective Payment System.

According to the company, the Thoraflex Hybrid FET device allows patients with suitably limited disease to be treated in a single-stage procedure rather than two procedures, which has previously been the conventional pathway in the United States for this group of patients.

The add-on payment will allow hospitals to be reimbursed for the incremental costs relating to the implantation of the Thoraflex Hybrid FET device to support the treatment of patients with complex aortic arch disease; this is in addition to the diagnosis-related group reimbursement.

Terumo Aortic advised that the add-on payment is effective in CMS’s FY23, beginning October 1, 2022. It has been assigned the maximum NTAP, which is 65% of the average cost of the technology for a case involving the use of the Thoraflex Hybrid device.

The Thoraflex Hybrid FET repair device was launched in the United States in July 2022 after receiving FDA approval announced in April.

A Breakthrough Device designation was granted by the FDA in April 2020.

The Thoraflex Hybrid device received European CE Mark approval in 2012, noted Terumo Aortic.