Pulnovo Medical

Company overview

Pulnovo Medical develops catheter-based pulmonary artery denervation (PADN) technology for pulmonary hypertension and heart failure-related research. Established in 2013, it has roots and a device manufacturing entity in Wuxi, China, and lists New York as its headquarters. Jessie Lian is Executive Director and CEO; Cynthia Chen is Chairlady and President.

Its PADN platform combines a radiofrequency ablation catheter with a generator to target overactive sympathetic nerves around the pulmonary arteries. Pulnovo reports commercial activity in selected non-U.S. markets, including a first commercial procedure in Italy in March 2026 following CE-MDR certification in 2025. In the United States, the Enhancor PADN system remains investigational in clinical studies. The separately FDA-cleared PFlexi introducer sheath provides vascular access and does not confer U.S. marketing authorization on the PADN therapy.

Pulnovo completed a US$100 million strategic financing round led by Medtronic in April 2026 and entered a separate agreement contemplating future commercialization opportunities. Its clinical program includes the recruiting PULSE-LHD study and the separate Chinese PADN-HF-PH randomized trial, whose results were published in the New England Journal of Medicine in August 2026.

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Products & regulatory status How does MedTechIndex get this information?

Summary

FDA cleared Pulnovo Medical (Wuxi)’s PFlexi introducer sheath under K242756 on November 8, 2024. The Class II device is intended to introduce diagnostic and therapeutic devices into the human vasculature, including intracardiac, renal and other peripheral placements; neural placements are excluded. This clearance covers the sheath, not pulmonary artery denervation therapy. ^{[2][6][5][3][1][8][7][10]}

The Enhancor PADN system is investigational in the United States. PULSE-LHD (NCT07214376) is a randomized placebo-procedure-controlled study comparing PADN plus guideline-directed medical therapy with a control procedure plus medical therapy. Its October 2026 registry update lists recruiting status and estimated enrollment of 750; this is a planned sample size, not a treated-patient count. CMS lists the study under IDE G250159. ^{[2][6][5][3][1][8][7][10]}

Pulnovo reports CE-MDR certification for its PADN products in 2025 and commercial use in Italy in March 2026. These non-U.S. market milestones do not authorize U.S. sale. Separately, the published 264-patient PADN-HF-PH trial in China reported fewer clinical-worsening events with denervation plus medical therapy than medical therapy alone. That evidence comes from a distinct study and does not establish PULSE-LHD outcomes. ^{[2][6][5][3][1][8][7][10]}

Regulatory snapshot How to read this snapshot

U.S. FDA

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510(k) clearances

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De Novo grants

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PMA approvals

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Recall events

Latest recorded source review: 2026-11-05.

Scope: selected product families.

Commercial portfolio snapshot

Documented commercial product families.

Pulmonary artery radiofrequency denervation system

PADN / Enhancor system ↗

Catheter-based radiofrequency platform combining a multi-electrode pulmonary artery ablation catheter and PHD360 generator. It is designed to modulate sympathetic nerve activity around the pulmonary arteries. Commercial activity is reported in selected non-U.S. markets; the Enhancor system is investigational in the U.S. PULSE-LHD trial. ^[6][1]

Selected non-U.S. commercialization · U.S. investigational

Vascular access sheath

PFlexi Introducer Sheath ↗

Introducer sheath for delivering diagnostic and therapeutic devices into the human vasculature, including intracardiac, renal and other peripheral placements. The FDA-cleared labeling excludes neural placements. The sheath is a separate product from the PADN ablation platform. ^[6][7]

FDA 510(k) cleared · K242756