Japan has granted national reimbursement to LivaNova's sutureless aortic heart valve, Perceval.
The action stands to increase access to a device designed to improve outcomes in patients with aortic valve disease by reducing the physiological impact of valve replacement.
Rising sales of Perceval have been a bright spot for LivaNova's heart valve unit at a time when multiple other factors have dragged on its performance.
Analyses of clinical data have linked Perceval to better outcomes than are achieved using stented prosthesis or transcatheter aortic valve implantation, leading to more than 25,000 patients being treated with the sutureless heart valve. The path to approval and reimbursement in Japan has been longer than for other markets, though.
LivaNova received a CE mark for the device in 2011 and secured FDA approval five years later. Approval in Japan followed in 2018 but early uptake was limited by Perceval's absence from the list of products covered by the Ministry of Health, Labour and Welfare.
Now, Japan's MHLW has released the brakes on Perceval by granting it national reimbursement in the treatment of aortic valve disease. LivaNova thinks the insurance coverage decision will expand access to the device.
The MHLW decision follows a financial quarter in which LivaNova singled out "strong growth" in sales of Perceval outside of the U.S. and Europe as a positive for its heart valve business. LivaNova pointed to rising demand for Perceval globally as a highlight of its previous two quarters, too, but the positive trend has been too weak to counter headwinds elsewhere in the business.
Heart valve sales outside of the U.S. and Europe fell 14% in the third quarter. With sales in the U.S. and Europe falling too, total revenues at the business unit came in down 10%. Sales across the first nine months of the year were down 5%, largely due to weak performance in the rest of the world.
The reimbursement decision provides LivaNova with an opportunity to grow sales of Perceval in Japan and thereby put its heart valve business on a sounder footing outside of the U.S. and Europe.
Japan's move comes on the heels of another key coverage decision for LivaNova, with CMS announcing last week it plans to cover the company's vagus nerve stimulation device for treatment-resistant depression through the Coverage with Evidence Development track.