January 9, 2020
JenaValve Pericardial TAVR System Receives FDA Breakthrough Device Designation
January 9, 2020—JenaValve Technology, Inc. announced that it has received FDA Breakthrough Device designation for its JenaValve pericardial transcatheter aortic valve replacement (TAVR) system for the treatment of aortic valve disease. This designation is for severe aortic regurgitation (AR) and AR-dominant mixed aortic valve disease in patients at high risk for surgery.
According to the company, the JenaValve pericardial TAVR system consists of a bioprosthesis composed of a self-expanding nitinol stent with a porcine pericardial valve manufactured using state-of-the-art tissue processing techniques. The TAVR system is available in three sizes to treat a broad range of aortic annulus diameters.
The JenaValve pericardial TAVR system is an investigational device. It is not available for sale in the United States or internationally, advised the company.
JenaValve is the sponsor of a United States investigational device exemption and is conducting a multicenter clinical program for the treatment of patients with severe AR who are at high risk for surgery. It is anticipated that the company will file for United States humanitarian device exemption approval in the second half of 2020. JenaValve advised that it will continue to enroll patients in the clinical program throughout the year to support a future premarket approval application to the FDA as part of the Breakthrough Device program.
The FDA Breakthrough Device program is intended to help patients receive more timely access to breakthrough medical technologies that have the potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions. Under the program, the FDA will provide JenaValve with priority review and interactive communication regarding device development and clinical trial protocols, through to commercialization decisions.