Nova Vascular

Some things are worth protecting.

Introducing

NovaSeal™

The large-bore introducer sheath, engineered around one multi-device hemostatic valve.

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The Hemostatic Valve

One valve,
sealed around everything.

NovaSeal's hemostatic valve conforms around guidewires, catheters, and large-bore systems moving together through a single lumen — designed to minimize blood loss through every exchange of the case.

Multi-device access, one seal Designed to minimize blood loss One 2.5 mL saline prep per the IFU
NovaSeal introducer sheath — charcoal valve cap, hub with two blue side-arm stopcocks, royal-blue hydrophilic shaft and silver tapered tip
The Complete System

One sheath. Every exchange covered.

A complete large-bore access platform — the hemostatic valve hub, dedicated VALVE and FLUSH side-arm stopcocks, a hydrophilic shaft, radiopaque marker and atraumatic tip — sterile, single-use, ready off the back table.

Two side-arm stopcocks — the VALVE port and the FLUSH port
Radiopaque visualization ring for precise fluoroscopic placement
Tapered dilator accepts a 0.035″ guidewire for smooth coaxial entry
Vascular Access

A confident path into the vessel.

Soft tapered tip, hydrophilic shaft, coaxial entry over a 0.035″ guidewire — engineered for smooth, atraumatic large-bore access.

Engineered Throughout

Designed to seal, track, and place with precision.

Hemostatic Valve

One valve lumen that keeps its seal around multiple wires and catheters at once — through every device exchange.

Hydrophilic Coating

A lubricious coating along the working length for smoother advancement through tortuous, challenging anatomy.

Visualization & Tip

A radiopaque ring for precise placement and a soft tapered tip designed to reduce vessel trauma on insertion.

Range & Coverage

The breadth a hybrid room needs.

Fifteen consecutive French sizes — every single size from 12 to 26 Fr — each available in all three working lengths. A full 45-configuration grid, so the exact sheath for the case is simply on the shelf.

12–26Fr
Every 1 Fr — 15 sizes
3
Working lengths
330–650mm
Length coverage
0.035″
Guidewire
510(k)
FDA cleared · K251838

All sizes and lengths per the cleared Instructions For Use, Table 1 — full matrix below.

Specifications

Product at a glance.

NovaSeal™ Introducer Sheath Set

US FDA 510(k) · K251838
Device typeSterile, single-use introducer sheath set (sheath + dilator), EO sterilized
Hemostatic sealMulti-device hemostatic valve with dedicated VALVE and FLUSH side-arm stopcocks — one 2.5 mL saline preparation per the IFU
French sizes12 – 26 French — fifteen consecutive sizes, every 1 Fr
Working lengths330 / 450 / 650 mm — every length available in every size (45 configurations)
GuidewireDilator accepts 0.035 in (0.89 mm) or smaller
Key componentsSheath tube & hub, hemostatic valve, VALVE and FLUSH side-arm stopcocks, radiopaque visualization ring, dilator, hydrophilic coating
Indication (IFU)Inserted in the vasculature to provide a conduit for the insertion of endovascular devices while minimizing blood loss associated with such insertions

Clinical & compliance note. Factual device claims trace to the cleared Instructions For Use and manufacturer product literature; comparative and procedural benefits are framed as design intent. Final clinical decisions defer to cleared labeling, facility protocols, and clinician judgment.

Size Matrix

Every size. Every length.

The full cleared configuration grid — fifteen consecutive French sizes, each in 330, 450, and 650 mm working lengths.

45 of 45 cells filled · every size, every length
12 Fr · 4.8 mm ODNominal outer diameters — true relative proportion26 Fr · 9.5 mm OD

NovaSeal grid per the cleared IFU, Table 1 (K251838). Competitor view reflects the published size matrix of a typical large-bore introducer sheath line across 12–26 Fr, per manufacturer specifications (June 2026); that line also offers one size below 12 Fr — approximately 21 configurations in total. Shown for range illustration; verify current availability with each manufacturer.

Sheath configurations — IFU Table 1

45 configurations
French sizeSheath Min. IDSheath Nom. ODWorking lengths
12 Fr3.9 mm4.8 mm330 · 450 · 650 mm
13 Fr4.3 mm5.0 mm330 · 450 · 650 mm
14 Fr4.6 mm5.3 mm330 · 450 · 650 mm
15 Fr4.9 mm5.6 mm330 · 450 · 650 mm
16 Fr5.3 mm6.1 mm330 · 450 · 650 mm
17 Fr5.6 mm6.4 mm330 · 450 · 650 mm
18 Fr5.9 mm6.7 mm330 · 450 · 650 mm
19 Fr6.3 mm7.1 mm330 · 450 · 650 mm
20 Fr6.6 mm7.5 mm330 · 450 · 650 mm
21 Fr6.9 mm7.8 mm330 · 450 · 650 mm
22 Fr7.3 mm8.2 mm330 · 450 · 650 mm
23 Fr7.6 mm8.5 mm330 · 450 · 650 mm
24 Fr7.9 mm8.8 mm330 · 450 · 650 mm
25 Fr8.3 mm9.2 mm330 · 450 · 650 mm
26 Fr8.6 mm9.5 mm330 · 450 · 650 mm

French size designations reflect the device-accepting inner lumen; sheath Min. ID and Nom. OD per the cleared IFU, Table 1. Matching dilator supplied in every set (accepts 0.035 in guidewire). Catalog numbers available on request.

Clinical Applications

Built for procedures that demand large-bore confidence.

One access platform, five procedures. In every one, NovaSeal is the conduit — the therapy travels through it, and the seal holds.

Infrarenal aorta

Aortic · EVAR

Main body up one femoral conduit, contralateral limb through the other — two seals holding through every exchange.

PA bifurcation

Pulmonary Embolism

A femoral venous conduit for large-bore aspiration systems traveling through the right heart — hemostasis held across repeated passes.

Aortic annulus

Structural · TAVR

Transfemoral valve delivery, blood loss controlled as large systems move in and out.

Descending thoracic

Aortic · TEVAR

Long working lengths reach the descending thoracic aorta, distal to the left subclavian.

Iliofemoral vein

Deep Venous · DVT

Venous access where profile and lubricity are designed to minimize access-site trauma.

Representative illustrations. Rendered device configurations and anatomy are illustrative of intended use as an access conduit; therapy devices shown are not Nova Vascular products.

The Platform

NovaSeal is the first of the system.

A growing platform of vascular-access and intervention devices — engineered to one standard, designed to work together.

Available now

NovaSeal™

Large-bore introducer sheath

In development

NovaCross™

Crossing & support microcatheter

In development

NovaFlow™

Mechanical thrombectomy platform

In development

NovaGuide™

Steerable guiding sheath

Evaluation Program

Step inside. Put NovaSeal on your back table.

Sample evaluation, in-service training, cleared IFU and regulatory documentation, and procurement onboarding — coordinated end to end. Account-specific pricing provided upon request.

Request Samples Request Documentation
Download size matrix (PDF)