News | April 02, 2015

CoreValve Transcatheter Valve Approved in Japan

Device found to improve heart failure class, all-cause mortality in more than 90 percent of Japanese patients

Medtronic, CoreValve, Japan, approval, trial

April 2, 2015 — Medtronic announced Japanese regulatory approval for the self-expanding transcatheter CoreValve system for patients with severe aortic stenosis (AS). Japanese regulatory authorities granted approval of the CoreValve system for transcatheter aortic valve implantation (TAVI) based on data from the CoreValve U.S. Pivotal Trials and the Medtronic CoreValve Japan Trial, which is the first study to evaluate a self-expandable transcatheter valve in the Japanese patient population.

“We are excited to be able to offer this new option for our patients, as the CoreValve system has demonstrated exceptional clinical results in studies globally as well as in Japan,” said Yoshiki Sawa, M.D., professor in the Department of Cardiovascular Surgery at Osaka University Graduate School of Medicine in Osaka, Japan. “Physicians in Japan should have confidence in making TAVI treatment decisions for patients who may benefit from a less invasive valve replacement procedure with this proven self-expandable valve.”

Data from the Extreme and High Risk Studies in the CoreValve U.S. Pivotal Trial demonstrated that the CoreValve system is safe and effective with high rates of survival and some of the lowest rates of stroke and valve leakage reported. Featuring a supra-annular valve design, the system has also achieved hemodynamics post-implant with results similar to the gold standard, surgical valves.

The Medtronic CoreValve Japan Trial confirmed the performance of CoreValve shown in the U.S. Pivotal Trial. At 6 months, 91.7 percent of the transfemoral patients in the Japan trial met the primary endpoint of improvement of at least one New York Heart Association class and aortic valve area greater than 1.2 cm2. For all patients in the trial, freedom from all-cause mortality at 6 months was 90.8 percent. The trial also demonstrated functional and anatomical effectiveness of CoreValve.

The CoreValve self-expanding nitinol frame enables physicians to deliver the device to the diseased valve in a controlled manner, allowing for accurate placement. Valves are delivered via the smallest (18Fr, or approximately 1/4 inch) TAVR delivery system available, making it possible to treat patients with difficult or small vasculature.

The device is indicated for patients with severe AS unable to undergo surgery, and for whom treatment with the CoreValve is determined to be the best option.

For more information:

Related Content

Boston Scientific Prevails in U.S. Edwards Lifesciences Litigation
Feature | Heart Valve Technology | December 12, 2018
A jury in the U.S. District Court for the District of Delaware determined Dec. 11 that the Boston Scientific U.S....
First TriCinch Coil Tricuspid Repair Systems Implanted in U.S.
News | Heart Valve Technology | November 06, 2018
4Tech Inc. initiated its U.S. Early Feasibility Study of the TriCinich Coil System following U.S. Food and Drug...
Valve Replacement Volume Key to Successful Patient Outcomes
News | Heart Valve Technology | November 02, 2018
Hospitals that routinely perform a heart valve replacement procedure requiring open heart surgery are more likely to...
Prosthetic Valve Mismatches Common in TAVR Procedures
News | Heart Valve Technology | October 03, 2018
A high number of patients in a study who underwent transcatheter aortic valve replacement (TAVR) experienced severe and...
Local Anesthesia Safe and Effective for Intermediate- and High-Risk TAVR Patients
News | Heart Valve Technology | September 28, 2018
The first randomized study to compare general versus local anesthesia during transcatheter aortic valve replacement (...
MitraClip Reduces Mortality for Heart Failure Patients With Secondary Mitral Regurgitation
News | Heart Valve Technology | September 26, 2018
Patients with heart failure and secondary mitral regurgitation (MR) who remained symptomatic despite maximally...
Ancora Heart Announces Positive Interim Analysis of AccuCinch Ventricular Repair System for Heart Failure
News | Heart Valve Technology | September 24, 2018
Ancora Heart Inc. announced positive clinical data from the company’s recently expanded U.S. early feasibility study...
Medtronic Announces TAVR Study of Aortic Stenosis Patients With Bicuspid Valves
News | Heart Valve Technology | September 19, 2018
The U.S. Food and Drug Administration (FDA) has approved an investigational device exemption (IDE) to initiate a new...
4C Medical's AltaValve First-in-Human Experience to be Presented at TCT 2018
News | Heart Valve Technology | September 17, 2018
September 17, 2018 — 4C Medical Technologies Inc.
Overlay Init