Vivasure Medical develops PerQseal® Elite, a 100% bio‑absorbable, sutureless patch‑based closure system for large‑bore arterial and venous access used in complex cardiovascular and endovascular procedures. The device requires a single deployment step, is compatible with 0.35″ guidewires, and eliminates pre‑procedure preparation, reducing procedure time and minimizing post‑procedure bleeding, hematomas, and pseudo‑aneurysms.
Funding
$32.2M raised to dateRaised to date based on public sources. This may differ from the amount the company actually raised and is based only on what is publicly available on the internet.
HFounders
Product
Problem
Large-bore arterial and venous access procedures require reliable closure to prevent bleeding, hematoma, and pseudo‑aneurysm, yet existing devices often involve sutures, metal clips, or collagen patches that can leave permanent material in the vessel and increase complication risk.
Solution
Vivasure Medical’s PerQseal® Elite is a fully bio‑absorbable, sutureless patch‑based closure system designed for 14–22 F arterial and up to 26 F venous sheaths. The single‑use device combines a Polydioxanone (PDO) polymer patch with an external fixation mechanism that compresses the implant from within the vessel, achieving hemostasis while minimizing trauma to the tissue tract. The patch degrades completely within approximately 180 days, restoring the vessel to its natural state without leaving permanent foreign material. The system is compatible with 0.35″ guidewires and maintains safety‑wire access, simplifying the workflow to a single device per closure with minimal deployment steps. Clinical data indicate low rates of hematoma and pseudo‑aneurysm, supporting faster patient recovery and reduced post‑procedure complications.
Target Audience
Primary customers are interventional cardiologists, vascular surgeons, and radiologists performing large‑bore endovascular and structural heart procedures, as well as hospitals and specialty clinics seeking efficient, low‑complication closure solutions.
Features
- 100 % bio‑absorbable Polydioxanone (PDO) patch that fully degrades within ~180 days
- Sutureless, single‑device workflow with no pre‑procedure preparation
- External fixation enhances compression and seal from inside the vessel
- Compatible with 0.35″ guidewires and maintains safety‑wire access for improved deliverability
- Designed for large‑bore arterial (14–22 F) and venous (up to 26 F) access sites
- CE‑Mark approved for use in Europe (not yet available in the United States)