Clinical Need

Large arteriotomy management is a unique challenge.
A fully percutaneous approach has become the standard of care for most structural heart and aortic vascular procedures. There is increasing awareness that large catheter sizes can create unique challenges that require a dedicated closure solution.

Technology

Designed for
purpose

Suitable for arteriotomies up to 24F
No pre-procedural steps – OTW delivery
One device per arteriotomy
Fully synthetic absorbable implant
No sutures, no collagen, no metal

Simple and secure
device deployment

Automatic loading – Simple and intuitive delivery
Safety Guidewire remains in situ until implant release
Dedicated 0.035” compatible introducer

Patch based fully
absorbable implant

Ultra-low profile patch, rapidly endothelialised¹
Implant fully absorbed within 180 days¹
Abluminal surface matrix promotes adherence and healing¹

Implant fully absorbed within 180 days¹

Vessel remains patent - restored to its pre-procedure state

Implanted Patch

32
Days

Implant Fully Encapsulated

91
Days

Implant extra-vascular-vessel remodeling

180
Days

Implant fully absorbed - vessel restored

Clinical Evidence

Frontier clinical programmes - An evolving database of safety and effectiveness

Closures across Frontier I-IV studies²

0 %

Technical success rate²

100

Major procedure related complication²

100 %

No late major or minor complication²

References:

1. Pre-clinical data – on file at Vivasure Medical

2. Clinical data Frontier I-IV studies on file at Vivasure Medical

About Us

Vivasure Medical Limited is a highly innovative medical device company based in the heart of Europe’s largest medtech hub in Galway, Ireland. The company develops advanced polymer implants and delivery systems, primarily focused on minimally invasive vessel closure in cardiology, interventional radiology and vascular surgery.

Established in 2009, Vivasure operates a fully integrated, ISO 13485 certified, R&D and manufacturing facility. The company is staffed by an experienced team of medical device professionals with expertise spanning research, engineering, material science, quality, regulatory, manufacturing, clinical and commercial roles.