China-based cardiovascular disease solutions provider Lepu Medical Technology (Beijing) Co., Ltd (SHE: 300003) has announced that it has received Category III medical device approval from the National Medical Products Administration (NMPA) for its in-house developed peripheral cutting balloon. This approval marks a significant milestone for the company in expanding its product offerings in the treatment of peripheral arterial disease.
Innovative Peripheral Cutting Balloon
The newly approved peripheral cutting balloon is designed to offer enhanced treatment options for patients with peripheral arterial disease. Compared to conventional balloons, the product features three to four sets of microblades distributed on the surface of the balloon. These microblades can effectively cut through hyperplastic or mildly calcified intima, resulting in less irregular tearing of the vascular intima and reduced damage to blood vessels. Additionally, the design of the cutting balloon facilitates follow-up drug balloon adherent therapy, providing a more comprehensive treatment approach.
Market and Clinical Significance
Lepu Medtech’s peripheral cutting balloon is the only Chinese product of its kind approved to treat peripheral arterial disease in the country. This unique position highlights the company’s commitment to innovation and its ability to address unmet clinical needs in the cardiovascular space. The approval is expected to strengthen Lepu Medtech’s market presence and further establish its reputation as a leading provider of advanced cardiovascular solutions.-Fineline Info & Tech
