Pulnovo Medical Limited, a globally recognized pioneer in medical device for Pulmonary Hypertension (PH) and Heart Failure (HF), is proud to announce that its Introducer Sheath has successfully received FDA 510(k) clearance. This milestone marks Pulnovo’s fifth FDA designation and reinforces the company’s commitment to delivering high-quality, reliable medical solutions worldwide.

The Introducer Sheath is specifically designed for use in interventional procedures, particularly in conjunction with PADN (Pulmonary Artery Denervation) technology, a cutting-edge treatment for pulmonary hypertension. The sheath's innovative design enhances clinical precision and improves patient outcomes by providing optimal vascular access and facilitating the seamless delivery of PADN treatments. This synergy with Pulnovo Medical’s PADN series products enables improved blood flow and reduces treatment risks, leading to better clinical outcomes. Additionally, the sheath offers compatibility with a broad range of interventional devices, increasing procedural efficiency, reducing operation times, and minimizing risks of vessel damage, thereby prioritizing patient safety.

With the FDA 510(k) clearance, Pulnovo Medical is now poised to officially launch its products in the U.S. market, a significant step in the company’s commercial expansion strategy. This approval will also allow Pulnovo to extend comprehensive technical support to clinicians and patients with pulmonary hypertension worldwide, underscoring its dedication to advancing innovative care solutions.

The certification supports Pulnovo Medical’s vision of global growth. The company plans to expand its product portfolio and invest in new technologies to address the evolving needs of healthcare professionals and patients.

About Pulnovo Medical

Pulnovo Medical Limited, is a globally recognized device pioneer in the treatment for pulmonary hypertension and heart failure. Established in 2013 and rooted in innovation, Pulnovo Medical is committed to leveraging our deep expertise in the science of breakthrough technologie with the goal to market our innovative therapeutic solutions and benefit patients around the world.