Pulmonary Artery Denervation (PADN) Study by Pum Medical Published in NEJM; Medtronic Invests $700M in Cornerstone Robotics

Medical News Morning Brief · Issue 4298

September 3 · Thursday

Medical Device Professionals' Daily Intelligence Hub · Understand Major Medical Device News in 5 Minutes a Day

Today's Topic

Domestic Innovative Medical Devices Speak with Clinical Evidence: RCTs in Top-Tier Journals Establish Value, “Chinese Evidence” Goes Global

? In-Depth: Pulnovo’s PADN Study Published in The New England Journal of Medicine (First Asian Global Innovative Medical Device to Top NEJM)
📉 CMDE Releases 55 Registration Review Guidelines; Xinwei Medical Reports Interim Results, MicroPort-Related Stocks Halted
? Medtronic Invests 700 Million in Cornerstone Robotics; Enovis Acquires eCential

Pulnovo Medical’s PADN-HF-PH Study Published in The New England Journal of Medicine: First Asian Global Innovative Device to Top International Prestigious Journal

ESC 2026 Munich Hot Line 6 Simultaneously Announced · First Device RCT in the PH-LHD Field to Meet Primary Endpoint · 51% Reduction in Risk of Clinical Deterioration

? Key Summary

On August 30, Professor Chen Shaoliang from the First Affiliated Hospital of Nanjing Medical University presented the complete results of the PADN-HF-PH study at the Hot Line 6 session of ESC 2026 in Munich, with the findings simultaneously published in The New England Journal of Medicine (NEJM, Impact Factor: 84.5). The study enrolled 264 patients with pulmonary hypertension due to left heart disease (PH-LHD) and heart failure across 25 centers in China, who were randomized in a 1:1 ratio to receive either Pulmonary Artery Denervation (PADN) plus Guideline-Directed Medical Therapy (GDMT) or GDMT alone. Results showed that after adjusted follow-up over two years, the incidence of clinical worsening was 25.7% in the PADN group versus 51.1% in the control group (HR 0.49, 95% CI 0.30–0.82, P=0.006), representing a 51% reduction in the risk of clinical worsening and a 35.5% reduction in recurrence rate. This marks the first registered clinical study of a globally innovative medical device technology from Asia to be published in NEJM, as well as the first device-based randomized controlled trial (RCT) in the PH-LHD field to achieve its primary endpoint. The PADN (Pulmonary Artery Denervation) product series has obtained EU CE-MDR certification and FDA Breakthrough Device designation.

? Background Interpretation

PADN reduces pulmonary vascular resistance and improves right heart function by percutaneous catheter-based ablation of the pulmonary artery sympathetic nerves, representing a new paradigm in device-based therapy for heart failure under the category of “neuromodulation”—distinct from traditional ICD/CRT (electrophysiological) therapies and ventricular assist devices. The study was published simultaneously in a top-tier journal and presented at an international conference, marking the transition of domestically developed innovative medical devices from the “preclinical/small-sample” stage to the “international large-scale RCT” phase, serving as a gold-standard milestone for “Chinese evidence” going global.

? Industry Impact

First Asian Global Innovative Medical Device Featured in NEJM: A Milestone for Chinese-Made Medical Devices in “Letting Clinical Evidence Speak”—Validating PADN Efficacy and Establishing the Capability of Chinese Teams to Lead International Registration Clinical Trials. This serves as a strong confidence booster for Chinese-made neuromodulation devices for heart failure and pulmonary hypertension (such as PADN and RDN), promoting an “evidence-based + internationalization” pathway; meanwhile, it warns against homogeneous competition within the industry—devices without high-quality RCTs will struggle to gain a foothold.

✅ Actionable Recommendations

For manufacturers: Benchmark against top-tier RCTs, proactively plan for registration clinical endpoint design, multi-center collaboration, and international publication; for neuromodulation devices, focus on evidence for indication expansion. For the industry: Chinese-made devices are transitioning from "manufacturing capability" to "evidence-based validation," with clinical benefit and international recognition becoming the main drivers of competition in the next phase.

Source: NEJM (August 30) · ESC 2026 Hot Line 6 (August 30)

CMDE Releases 55 Technical Guidelines for the Registration Review of Class II Passive Medical Devices (Batch 2) for Public Comment

On September 1, the Center for Medical Device Evaluation (CMDE) of the National Medical Products Administration released draft guidelines for public comment on 55 Class II passive medical device registration review guidelines (Batch 2). These cover 55 specific categories, including surgical staplers, implantable drug delivery devices, single-use drainage tubes, medical dressings, plastic surgery implants, and orthopedic consumables. The public comment period runs until October 8. Batch 2 extends the initial 50 guidelines issued in 2024 and aligns with the 2025 adjustments to the classification catalog for passive medical devices, with a focus on strengthening: (1) new requirements for biocompatibility evaluation of passive devices; (2) traceability of raw material supply chains; and (3) data integrity in process validation (PV). Relevant enterprises should submit feedback during the comment period; otherwise, they risk facing heightened registration review standards upon implementation of the final guidelines.

▶Registration Review Standards Continue to Rise—Biocompatibility, Supply Chain Traceability, and Process Validation Data Integrity for Passive Medical Devices Become Regulatory Focus; Companies Must Provide Feedback During the Comment Period to Influence the Final Draft.

Source: Center for Medical Device Evaluation (CMDE), National Medical Products Administration (September 1)

Jiangsu Provincial Medical Products Administration Issues No. 6 Priority Approval for Class II Medical Devices (Tianzong Wuxi Two-Dimensional Liquid Chromatography Analysis System)

On September 1, the Jiangsu Provincial Medical Products Administration released the Public Notice on the Review Results of Applications for Priority Approval of Class II Medical Devices (No. 6, 2026). Tianzong Wuxi Biotechnology’s Two-Dimensional Liquid Chromatography Analysis System (models Essential 2200/1100/1050) has entered the priority approval process, justified by its inclusion in the National Major Science and Technology Projects. This product serves as core equipment for the separation and analysis of biomacromolecules (proteins/peptides/antibodies), addressing critical stages in biopharmaceutical R&D and quality control. As a key IVD equipment enterprise introduced to the Wuxi High-Tech Zone, Tianzong Wuxi Biotechnology will see its commercialization process for domestic substitution of imports accelerated by this priority approval. As a major province in the medical device industry, Jiangsu has issued six batches of Class II priority approval announcements in 2026 to date, covering cutting-edge fields such as surgical robots, AI-based diagnostics, IVD equipment, and biomacromolecule analysis.

▶Priority Approval Extends to IVD Equipment/Biomacromolecule Analysis—Key Domestic Equipment Replacing Imports (Agilent/Waters) Gains Green Channel, Accelerating Registration for Integrated Software-Hardware Analysis Platform Enterprises.

Source: Jiangsu Provincial Medical Products Administration (September 1)

Xinwei Medical 2026 Interim Results: Revenue RMB 291 Million, +56.9%; Neurointerventional Volume Surges; 72 Registrations Across 16 Overseas Countries

On August 31, MicroPort NeuroTech (06609.HK) announced its interim results for 2026: revenue reached RMB 291 million (+56.9%), gross profit was RMB 208 million (gross margin of 71.5%, an increase of 3.3 percentage points), net profit attributable to shareholders was RMB 60.4 million (+18.5%), and adjusted net profit was RMB 70.4 million (+105.9%). Key products: The number of hospitals implanting intracranial thrombectomy aspiration catheters increased by approximately 200, with implant volume rising by 300% year-on-year; sales of intracranial stents (recognized as innovative medical devices by the NMPA) increased by 80%; and 130,000 units of the occlusion hemostasis system were implanted, representing an 80% increase. With 72 registration certificates across 16 countries/regions overseas, overseas orders in the first half of 2026 exceeded the full-year total of 2025. Chinese-made neurointerventional products are transitioning from "following" to "explosive growth."

▶Domestic Substitution in Neurointervention Enters Volume Validation Phase—Intracranial Aspiration Catheter Sales Surge 300%, Adjusted Net Profit Doubles, Combined with Overseas Registration Portfolio, Confirming the Profitability Inflection Point for the Leading Domestic Intracranial Intervention Player.

Source: HKEXnews (August 31) · Securities Times

Four HK-listed MicroPort Companies Halt Trading Collectively: 2026 Interim Report Delayed Due to Lease Accounting Treatment

On September 1, MicroPort Scientific Corporation (00853.HK), together with MicroPort NeuroTech (02172.HK), MicroPort MedBot-B (02252.HK), and VitaFlow Medical-B (02160.HK), simultaneously applied for temporary trading suspensions on the Hong Kong Stock Exchange. The reason cited was the need for additional time to finalize audit and accounting treatments related to lease arrangements, which would result in a delayed release of their 2026 interim results. The Hong Kong Stock Exchange imposes strict disclosure requirements regarding delays in publishing interim reports; all four companies stated that they would resume trading and publish their interim reports as soon as conditions permit. This marks the largest-scale incident involving lease accounting risks in the Hong Kong-listed medical device sector in recent times.

▶IFRS 16 Lease Accounting Becomes a “Minefield” for Hong Kong-Listed Medical Device Companies—Four MicroPort-Affiliated Firms Halt Trading Amid Risks of High Goodwill and Asset-Heavy Leases; Investors Should Monitor the Potential Impact of Lease Accounting on Profits

Source: China Securities Network · cnstock (September 1) · HKEXnews

[Corporate Global Expansion]

Medtronic Invests Approximately $700 Million in Cornerstone Robotics: The Only Company Globally Capable of Delivering Two Surgical Robotic Technology Platforms Simultaneously

On September 1, Medtronic (NYSE: MDT) announced a strategic partnership with Cornerstone Robotics, involving an investment of approximately $700 million and securing distribution rights for the Sentire laparoscopic surgical robot in selected approved markets outside the United States. The Sentire system received approval from China’s National Medical Products Administration (NMPA) in 2024, and subsequently obtained CE-MDR certification from the European Union and approval from Singapore’s Health Sciences Authority (HSA) in May 2026. It supports minimally invasive procedures in general surgery, gynecology, thoracic surgery, and urology. Headquartered in Hong Kong, Cornerstone Robotics operates a 30,000-square-meter manufacturing base in Shenzhen and has independently developed its full stack of core hardware, algorithms, imaging, and energy platforms. Its founder and CEO, Guo Kuisheng, is a former engineer at Intuitive Surgical. With this move, Medtronic becomes the only company globally capable of offering two surgical robot systems based on distinct technological pathways, delivered through an integrated channel and ecosystem. Morgan Stanley served as the exclusive financial advisor.

▶Capital + Channel Dual Drive: Medtronic Secures Ties with Emerging Chinese Robot Maker via $700 Million Strategic Investment, Directly Competing with Intuitive Surgical; Chinese Surgical Robots Gain Channel Endorsement from International Giants, Opening Pathways for Global Expansion.

Source: Medtronic PR (September 1) · Cornerstone Official Website (September 1)

[Overseas M&A]

Enovis Acquires Surgical Robotics Company eCential Robotics for €155 Million

On September 1, orthopedic medical device company Enovis (NYSE: ENOV) announced a binding acquisition offer for French surgical robotics firm eCential Robotics, with an equity value of approximately €176 million (corresponding to an enterprise value of €155 million), plus additional milestone payments of up to €35 million. The transaction is expected to close within the year. Headquartered in Grenoble, eCential has over 15 years of experience in computer-assisted surgery and orthopedic robotics R&D. Its core product, the Op.n platform, integrates surgical navigation and active robotic technology into a single architecture and has received approval for use in spinal surgeries in both the United States and Europe. Enovis plans to launch its next-generation robotic platform for total knee arthroplasty within two years, followed by expansion into shoulder applications, with commercialization anticipated by 2028. On August 26, eCential and Spineart jointly announced that the Op.n platform’s PERLA TL pedicle screw system had received FDA 510(k) clearance.

▶Orthopedic Giant Acquires Robotics Upstart—“Implant + Navigation/Robotics” Integration Becomes the Main Line of Competition in Orthopedics; Enovis Secures Positioning for the Next-Generation Platform in Total Knee Arthroplasty, Strengthening Its Competition with Stryker and Zimmer Biomet.

Source: Enovis Official Press Release (September 1) · MarketBeat (September 1)

ROPCA Arthur Fully Autonomous Musculoskeletal Ultrasound Robot + Diana AI Receives FDA 510(k) Clearance

On August 29, the FDA 510(k) database announced that ROPCA’s fully autonomous musculoskeletal ultrasound robot, Arthur, and its accompanying AI image analysis software, Diana, received 510(k) clearance (ROPCA issued an official press release on August 26). Under the supervision of medical professionals, Arthur automatically acquires standardized ultrasound images of the fingers, hands, and wrist joints, while Diana handles image analysis and automated report generation. The system is equipped with safety mechanisms such as collision detection, force limiting, and emergency stop functions. Arthur has held CE certification since 2022 and has completed over 5,400 scans across six European countries, covering 83,500 joints. Development background: The American College of Rheumatology (ACR) estimates that 72% of U.S. counties lack rheumatologists.

▶"Fully Autonomous Ultrasound Acquisition + AI Interpretation" Brings Musculoskeletal Diagnosis to Primary Care—FDA Clearance for Fully Autonomous Robots and AI Image Analysis Signals the Shift of "AI + Autonomous Ultrasound" from Radiology Departments to Primary Care and the Accessible Medical Device Sector.

Source: FDA 510(k) Database (Announced on August 29) · ROPCA Official Press Release (August 26)

OSMUNDA Perspective · OSMUNDA VIEW

Domestic Innovative Medical Devices Reach the Pinnacle of NEJM: Establishing the "Clinical Gold Standard" Through RCTs in Top-Tier Journals, as Chinese Evidence Goes Global

Pulnovo’s PADN-HF-PH Study Published in NEJM: A Milestone for Chinese-Made Medical Devices “Speaking with Clinical Evidence”—It Not Only Validates the Efficacy of Pulmonary Artery Denervation but Also Establishes the Capability of Chinese Teams to Lead International Registrational Clinical Trials, Advancing from “Manufacturing Capability” to “Evidence-Based Recognition.” As innovative Chinese-made devices gain footing through top-tier RCTs (Pulnovo’s PADN, Ge Junbo’s RDN for Heart Failure), international giants deepen ties with emerging Chinese innovators (Medtronic–Cornerstone Robotics, Enovis acquiring eCential), and autonomous robots scale up (Xinwei, ROPCA fully autonomous ultrasound), the industry’s competitive focus has shifted from “Can it be made?” to “Can it deliver high-quality, internationally recognized evidence plus accessibility?” In the next decade, the true watershed for Chinese-made medical devices will be the dual validation of “clinical gold standards” and “global accessibility.”

Source: Compiled by OSCA

— Data Snapshot —

51%

Reduction in the Risk of Clinical Worsening at 2 Years in the PADN Group

Pulnovo PADN-HF-PH Study (NEJM+ESC 2026): After adjusted 2-year follow-up, the incidence of clinical worsening was 25.7% in the PADN group vs. 51.1% in the control group (HR 0.49), representing a 51% reduction in the risk of clinical worsening and a 35.5% reduction in recurrence rate; involving 264 patients with PH-LHD combined with heart failure from 25 centers in China, this is the first global innovative device registration clinical trial from Asia to be published in NEJM.

— Word of the Day —

Pulmonary Artery DenervationPADN

Pulmonary Artery Denervation (PADN) refers to the percutaneous catheter-based ablation of sympathetic nerves surrounding the pulmonary artery, aimed at reducing pulmonary vascular resistance and improving right heart function. It is indicated for conditions such as pulmonary hypertension due to left heart disease (PH-LHD) complicated by heart failure. PADN represents a new paradigm in device-based therapy for heart failure under the category of "neuromodulation," distinct from traditional implantable cardioverter-defibrillators (ICDs), cardiac resynchronization therapy (CRT), and ventricular assist devices. The Pulnovo PADN-HF-PH study, published in the New England Journal of Medicine (NEJM), is the first registered randomized controlled trial (RCT) of a globally innovative medical device from Asia to be featured in NEJM, demonstrating a 51% reduction in the risk of clinical worsening.

— Morning Greetings —

“Let evidence speak, placing Chinese innovation on the world stage.”

— A Shared Commitment with Medical Device Professionals

Today's Source:Jiangsu Provincial Medical Products Administration · NEJM (New England Journal of Medicine) · Center for Medical Device Evaluation (CMDE), National Medical Products Administration · HKEXnews (Hong Kong Exchanges and Clearing Limited Disclosure Platform) · Medtronic PR · Cornerstone Robotics Official Website · Enovis Official Press Release · MarketBeat · FDA 510(k) Database · ESC 2026 (European Society of Cardiology) · China Securities Network (cnstock) · Sina Finance · Medspark · Ousida · Securities Times · ROPCA Official Press Release

[Disclaimer] The content of this morning report is sourced from public channels and is intended solely for reference and exchange among professionals in the medical device industry. It does not constitute any legal, regulatory, or compliance advice. Please refer to the official original text for authoritative information.

— Medical News Morning Brief · Issue 4298 · See You Tomorrow —

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