Pulnovo Medical's first US patient enrollments signal early progress in pulmonary artery denervation therapy for PH-LHD
Executive summary: Pulnovo Medical announced the enrollment of the first two U.S. patients in its PULSE-LHD IDE clinical trial evaluating pulmonary artery denervation for pulmonary hypertension associated with left heart disease. This early human data collection for a novel device-based therapy could address an unmet need in PH-LHD patients, potentially influencing treatment algorithms and the pulmonary hypertension device market.
Who is involved: Pulnovo Medical (sponsor), U.S. clinical sites (unspecified), FDA providing IDE oversight, and patients with pulmonary hypertension linked to left heart disease.
Likely next: Continued patient enrollment, safety monitoring, interim data readout, and potential progression toward a pivotal trial or FDA submission pending trial outcomes.
Pulnovo Medical announced that the first two U.S. patients have been enrolled in its PULSE-LHD investigational device exemption (IDE) trial, which tests pulmonary artery denervation as a treatment for pulmonary hypertension associated with left heart disease. The enrollment marks an early step toward generating safety and efficacy data for a device-based approach to a condition with limited therapeutic options. While the trial is still in its initial phase, successful outcomes could influence future treatment pathways and spur interest in similar denervation technologies. The development follows a series of prior IDE trials for other medical devices, indicating growing familiarity with the regulatory pathway for novel cardiovascular interventions.
Timeline
- — Pulnovo Medical Announces First Two U.S. Patients Enrolled in PULSE-LHD IDE Clinical Trial of Pulmonary Artery Denervation in Treating Pulmonary Hypertension Associated with Left Heart Disease (PR Newswire)
- — Nitinotes Announces Weill Cornell Medicine and NewYork-Presbyterian/Weill Cornell Medical Center Clinical Site Activation in the EASE™ IDE Trial (PR Newswire)
- — FastWave Medical Gains FDA IDE Approval to Begin Pivotal Trial of Artero™ Peripheral IVL System (PR Newswire)
- — Nitinotes Announces First Study Procedures at Orlando Health in the EASE™ IDE Trial (PR Newswire)
Analysis — what this means
Sectors affected
- Pulmonary artery denervation devices for pulmonary hypertension‑left heart disease (PH‑LHD)
Regulatory implications
- FDA IDE regulations (21 CFR §812) govern the PULSE‑LHD trial, requiring detailed investigational plan and safety reporting.
Historical parallels
- Nitinotes EASE IDE trial for EndoZip™ Automated Suturing System (August 2026)
- FastWave Medical FDA IDE approval for Artero™ Peripheral IVL System (August 2026)
- Nitinotes first study procedures at Orlando Health in the EASE™ IDE Trial (July 2026)
Key entities
Sources
- Pulnovo Medical Announces First Two U.S. Patients Enrolled in PULSE-LHD IDE Clinical Trial of Pulmonary Artery Denervation in Treating Pulmonary Hypertension Associated with Left Heart Disease — PR Newswire
- Nitinotes Announces Weill Cornell Medicine and NewYork-Presbyterian/Weill Cornell Medical Center Clinical Site Activation in the EASE™ IDE Trial — PR Newswire
- FastWave Medical Gains FDA IDE Approval to Begin Pivotal Trial of Artero™ Peripheral IVL System — PR Newswire
- Nitinotes Announces First Study Procedures at Orlando Health in the EASE™ IDE Trial — PR Newswire