China-based cardiovascular disease solutions provider Lepu Medical Technology (Beijing) Co., Ltd (SHE: 300003) has announced receiving Category III device approval (No. 20223071559) from the National Medical Products Administration (NMPA) for its in-house developed disposable pressure microcatheter. This approval marks a significant milestone in the company’s efforts to enhance precision in coronary stenosis treatment.
Product Application and Design
The disposable pressure microcatheter is designed to measure the pressure of diseased vessels in adult coronary arteries during coronary angiography and/or interventional surgery. It is applicable to primary lesions with visual stenosis of 40% to 80% and a reference vessel diameter of ≥ 2.5mm. The device allows for the calculation and acquisition of the coronary flow reserve fraction (FFR) by measuring pressure at both ends of the stenosis site.
Clinical Significance
The FFR value is a critical metric for evaluating the hemodynamic significance of coronary stenosis. An FFR value lower than 0.8 indicates that coronary stenosis has significantly led to myocardial ischemia, necessitating coronary artery revascularization through PCI or other interventional treatments. FFR has become the “gold standard” for functional evaluation of coronary stenosis, guiding precise treatment plans. Lepu Medical’s pressure microcatheter is an essential tool for accurate FFR measurement, supporting better clinical decision-making.-Fineline Info & Tech
