News | August 27, 2013

Edwards Receives Reimbursement Approval for Sapien XT Valve in Japan

The Sapien XT valve is the first commercially available transcatheter valve in Japan

August 27, 2013 — Edwards Lifesciences Corp. announced that Japan's Central Social Insurance Medical Council (Chuikyo) has approved the recommendation by the Japanese Ministry of Health, Labor and Welfare's (MHLW) expert review panel to provide reimbursement for the Edwards Sapien XT transcatheter aortic heart valve. The reimbursement is scheduled to go into effect on Oct. 1.

This decision follows regulatory approval of the Sapien XT valve in June. With this approval, Chuikyo established a reimbursement of 4.53 million yen (approximately $46,000 at current exchange rates) for when the Sapien XT valve is used in the treatment of patients with severe symptomatic aortic stenosis. The reimbursement rate for medical devices in Japan covers the cost of the device as well as taxes, certain hospital fees and distribution expenses.

The Sapien XT valve is the first commercially available transcatheter valve in Japan. In the United States, the Sapien XT valve is not commercially available; it is an investigational device being studied as part of a randomized, pivotal clinical trial.

For more information: www.edwards.com

Related Content

Mick Jagger Recovering After TAVR Procedure
News | Heart Valve Technology | April 08, 2019 | Jeff Zagoudis, Associate Editor
Rolling Stones frontman Mick Jagger is reportedly recovering after undergoing a transcatheter aortic valve valve...
 Evolut Low Risk Trial compared the minimally invasive Evolut transcatheter aortic valve replacement (TAVR) system to the gold standard of open-heart surgery in characteristically younger, healthier aortic stenosis patients. The randomized trial, which met its primary non-inferiority endpoint of all-cause mortality or disabling stroke at two years compared to surgery (5.3 vs. 6.7 percent; posterior probability of non-inferiority >0.999), was presented at the American College of Cardiology (ACC) 2019 meeting
News | Heart Valve Technology | April 03, 2019
April 3, 2019 – The ACC.19 late-breaking landmark Evolut Low Risk Trial compared the minimally invasive Evolut transc
TAVR Outperforms Surgery in Younger, Low-Risk Aortic Stenosis Patients
News | Heart Valve Technology | March 22, 2019
Among patients with severe symptomatic aortic stenosis at low surgical risk, transcatheter aortic valve replacement (...
ACC Launches Transcatheter Valve Certification
News | Heart Valve Technology | March 14, 2019
March 14, 2019 — Beginning in mid-2019, hospitals performing...
FDA Approves MitraClip for Use in Heart Failure Patients With Functional Mitral Regurgitation
Feature | Heart Valve Technology | March 14, 2019 | Jeff Zagoudis, Associate Editor
March 14, 2019 — The U.S.
Scientists Discover New Type of Immune Cells Essential for Forming Heart Valves

Microscopic images of a normal heart valve in a mouse, left, and a heart valve grown in a lab with heart-derived macrophages blocked, right. Without those macrophages, the valves are thick and deformed. Image courtesy of Developmental Cell/UCLA Broad Stem Cell Research Center.

News | Heart Valve Technology | March 06, 2019
UCLA researchers have identified for the first time the origin of an immune cell that plays a critical role in the...
Global Market for Transcatheter Treatments to Double in Next Five Years
News | Heart Valve Technology | March 01, 2019
When it comes to treatment options for a damaged heart valve, nothing is getting more attention than transcatheter...
Overlay Init