Suzhou Jiecheng Medical Technology Co., Ltd has announced that it has obtained Breakthrough Devices Designation (BDD) from the US Food and Drug Administration (FDA) for its proprietary transvascular interventional biological aortic valve. The device is designed for the treatment of severe aortic valve regurgitation (insufficiency) and mixed aortic valve disease with regurgitation, addressing a significant unmet need as there is no interventional aortic valve product approved for marketing in the US.
Advantages of the Transvascular Approach and Clinical Benefits
The product offers a transvascular (femoral artery) approach, providing more access options for patients. This approach is associated with several advantages, including shorter operation times, reduced surgical trauma, and faster patient recovery. The valve is capable of treating both aortic valve regurgitation and stenosis, with particular efficacy in treating simple non-calcified aortic valve regurgitation, where it offers unique benefits.
Humanitarian Use and Clinical Experience
The device has already been used to treat over 30 patients in the US and Canada through humanitarian channels, demonstrating its potential impact on patient care and clinical outcomes.-Fineline Info & Tech
