Vivasure Medical®, a leader in fully absorbable technology for percutaneous vessel closure, will reveal the findings from its U.S. PATCH Study at the Transcatheter Cardiovascular Therapeutics (TCT) 2024 conference in Washington, D.C., from October 27-30, 2024. The study evaluates the safety and efficacy of the Vivasure PerQseal® Closure Device System. Lead investigators will share insights from this research alongside results from the ELITE and ELITE Venous studies, highlighting a non-invasive approach for large-bore venous procedures.
The Vivasure PerQseal® is the first sutureless, fully absorbable device designed for large-bore vessel punctures, providing an alternative to traditional suture or collagen-based closure methods. It’s utilized in various procedures, including transcatheter aortic valve replacement (TAVR), aiming to minimize vascular complications while simplifying the closure process.
The U.S. PATCH Clinical Study has enrolled over 145 patients across 17 investigational sites in the U.S. and Europe, with the results supporting a pre-market approval submission to the U.S. Food and Drug Administration (FDA).
Additionally, Vivasure’s ELITE and ELITE Venous studies have enrolled around 100 patients across 12 European sites. The PerQseal ELITE can address both large-hole arterial and venous procedures, with results contributing to CE mark and pre-market approval applications.
TCT Presentation Details:
- Presentation Type: TCT Innovations 2 – Innovations in Endovascular Therapies
Title: Final Results of the PATCH Study of the Vivasure PerQseal® System for Large Hole Closure
Principal Investigator: William A. Gray, MD, Main Line Health
Date: Monday, October 28, 2024
Time: 8:40 – 8:47 a.m.
Location: Innovation Theater, Innovation & Exhibit Hall (Halls A-C), Lower Level - Presentation Type: TCT Innovations 2 – Innovations in Endovascular Therapies
Title: First in Man Experience of the Vivasure PerQseal® ELITE System for Large Hole Closure: The ELITE and ELITE Venous Studies
Principal Investigator: Nicolas M. Van Mieghem, MD, PhD, Erasmus University Hospital
Date: Monday, October 28, 2024
Time: 8:47 – 8:54 a.m.
Location: Innovation Theater, Innovation & Exhibit Hall (Halls A-C), Lower Level - Presentation Type: Scientific Symposium
Title: Large Hole Closure for Structural Interventions
Principal Investigator: Nicolas M. Van Mieghem, MD, PhD
Date: Monday, October 28, 2024
Time: 3:45 – 4:05 p.m.
Location: Presentation Theater 4, Innovation & Exhibit Hall (Halls A-C), Lower Level
About Vivasure Medical
Based in Galway, Ireland, Vivasure focuses on developing advanced polymer implants and delivery systems for minimally invasive vessel closure in cardiology, interventional radiology, and vascular surgery. The company operates an integrated R&D and ISO 13485 certified manufacturing facility, supported by prominent international medtech investors.
