PerQSeal Elite大口径经皮血管闭合系统
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15亿出售!全球首个无缝合全降解大口径血管闭合器
思宇MedTech· 2026-01-12 04:18
Core Viewpoint - Haemonetics has completed the acquisition of Vivasure Medical, enhancing its interventional technology portfolio with Vivasure's PerQSeal Elite large-bore vascular closure system, which is crucial for structural heart disease and vascular interventions [2][8]. Group 1: Acquisition Details - The acquisition was completed for approximately €100 million (about $116 million) as an upfront payment, with a potential contingent consideration of up to €85 million (about $98.9 million), totaling €185 million (approximately 1.5 billion RMB) based on future sales growth and milestones [2]. - The funding for the acquisition came from Haemonetics' own cash reserves, marking a strategic shift towards high-growth interventional technologies after divesting its whole blood business [2][9]. Group 2: Product Focus - Vivasure's PerQSeal Elite system is positioned in the high-barrier and clinically demanding niche of large-bore vascular closure, described as the world's first sutureless, fully bioabsorbable synthetic implant for large-bore vascular closure, suitable for puncture sites up to 26F [4]. - Unlike traditional external closure methods, PerQSeal Elite utilizes an internal closure pathway, deploying a proprietary absorbable patch to achieve closure, which is particularly beneficial for calcified vessels and complex anatomical conditions [6]. Group 3: Clinical and Regulatory Progress - The PerQSeal Elite system received CE marking in April 2025, expanding its indications to include large-bore venous closure, and a PMA application was submitted to the FDA in June 2025 based on clinical data from studies including PATCH and ELITE [7]. - The ELITE study demonstrated a significant safety profile with a major complication rate of 0% during a 30-day follow-up, supporting the system's operational safety and efficacy in complex interventional scenarios [7]. Group 4: Strategic Implications - The acquisition of Vivasure is part of Haemonetics' broader strategy to shift focus from capital-intensive traditional segments to high-value interventional consumables, emphasizing critical components in interventional procedures [8][9]. - The growing demand for procedures like transcatheter aortic valve replacement (TAVR) and transcatheter mitral valve repair/replacement (TMVR) highlights the importance of safe closure of large-bore access sites, which directly impacts postoperative complications and overall treatment efficiency [8].