GALWAY, Ireland--(BUSINESS WIRE)--Vivasure Medical®, a company pioneering novel fully absorbable technology for percutaneous vessel closure, today announced that it will unveil the results of its U.S. PATCH Study evaluating the safety and efficacy of the Vivasure PerQseal® Closure Device System at the Transcatheter Cardiovascular Therapeutics (TCT) 2024 annual conference in Washington, D.C., October 27-30, 2024. Lead investigators of the PATCH Study as well as the ELITE and ELITE Venous studies will discuss outcomes and share insights from their experience at the forefront of introducing a non-invasive, controlled technique for large-bore venous procedures.
The Vivasure PerQseal® Closure Device System is the first sutureless, fully absorbable synthetic implement for large-bore vessel punctures, and is an alternative to the use of suture- or collagen-based closure devices. It is used for large hole arterial access and is needed for a variety of procedures including transcatheter aortic valve replacement (TAVR) and numerous other large hole cardiovascular procedures. The goal of the device is to reduce vascular complications while simplifying the closure.
Vivasure’s U.S. PATCH Clinical Study has enrolled over 145 patients across seventeen U.S. and European investigational sites. The data will support a pre-market approval submission to the U.S. Food and Drug Administration (FDA).
Vivasure’s ELITE and ELITE Venous clinical studies have enrolled approximately 100 patients at 12 European investigational sites. Unlike PerQseal, PerQseal ELITE can close both large hole arterial and large hole venous procedures. Completion of these studies will support CE mark and pre-market approval submissions.
Full List of TCT Presentation Details:
PerQseal® Closure Device System
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, system chief in the division of cardiovascular disease at Main Line Health, co-director at the Lankenau Heart Institute in Philadelphia
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 (FIM) 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 in Rotterdam, Netherlands
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 is focused on the development of advanced polymer implants and delivery systems, primarily focused on minimally invasive vessel closure in cardiology, interventional radiology and vascular surgery. Vivasure operates a fully integrated R&D and ISO 13485 certified manufacturing facility and is backed by leading international medtech investors. For more information, please visit www.vivasuremedical.com.
The PerQseal® is not available for sale in the United States.
