Seal-V™ is a protein-free, strong, safe, bio-compatible, and bio-resorbable vascular sealant designed for a broad range of vascular surgery procedures. It is a sophisticated sealant and the only sealant in the market that enables precise control of the curing process. These features, together with the excellent adherence capabilities of Seal-V™ to wet surfaces, successfully resolve the limitations of both protein-based and synthetic sealants.
Seal-V™ is based on a novel combination of an Alginate Pre-Gel and a Curing Mesh. Surgeons have absolute control of vascular sealing due to the fact that spreading is completely separated from curing. Thus, unintentional dispersion and difficult cleanup are avoided. Upon application of the hardening mesh, Seal-V™ cures within 1 minute.
Seal-V™ is ready for use – no thawing, warming, and pre-mixing prior to use are required. Seal-V™’s viscous texture allows easy application and prevents the product from spreading on the surrounding tissue. A conspicuous blue color facilitates visualization.
* For detailed product description see instructions for use
- Rapid and effective hemostasis
- 95% hemostasis after only 1 minute following application was acheived in a clinical study in human patients
- Intrinsic ability to stick to wet surfaces – no need for drying
- Mechanical sealing – no need to activate blood coagulation
- Firm binding to vessel tissue and synthetic grafts
Ease of Use
- Protein-free, no protein-related risks
- No swelling
- Bio-resorbed in up to 3 months
- Reversible procedure – pre-gel leakage can be easily wiped from non-targeted tissue, prior to applying the Curing Mesh
- Ready-to-use and easily applied
- Highly viscous for accurate application
- Clear visualization (blue colored)
- Controlled application process (spreading separated from curing)
Seal-V™ is a dual component sealant for use in peripheral vascular procedures. Seal-V™’s adherence capabilities are based on the on-site interaction of its two separate components:
The Pre-Gel is a viscous alginate solution, dyed blue for easy visualization.
The Mesh component contains a curing agent which serves two purposes: it induces curing of the Pre-Gel upon contact and, in addition, serves as a reinforcing element. This adds to the mechanical strength of the cured adhesive.
Application of Seal-V™ is performed in two simple steps – applying the Pre-Gel, and then applying the Curing Mesh. Complete curing takes place in under one minute.The separation of the process into two steps allows the surgeon to safely apply the Pre-Gel around the anastomosis, making certain that it is fully covered, before initiating the curing process. This ensures minimal application failure and maximal control of the sealing results.
Seal-V™ is intended to achieve hemostasis by mechanically sealing areas of potential leakage in surgical reconstruction of large blood vessels such as the carotid, femoral, brachial and iliac arteries.
Seal V is considered a Class III medical device.
A clinical study in human subjects showed that the average time to hemostasis (bleeding cessation) using Seal-V was approximately 36 seconds. In 95% of the applications hemostasis was achieved within only 1 minute after application. No device related complications or adverse events were reported during the three-month follow-up period.
The clinical study was a prospective, single-arm, non-randomized clinical trial and involved 23 patients and 38 vascular reconstruction sites using various types of graft materials. The study met all primary and secondary end-points; it was conducted in three medical centers in Israel.
Seal-V™ received European CE Mark in July 2013.
Seal-V™ is biocompatible as determined by the full battery of biocompatibility assessment tests in accordance with ISO 10993:2009, for a device classified for >30 days permanent contact duration.