Facilitated vascular anastomoses: the one-shot device

Area of Science:

• Vascular Surgery
• Biomedical Engineering
• Surgical Instrumentation

Background:

• A mechanical system was developed to facilitate vascular anastomosis, enabling rapid construction of nonpenetrated, compliant junctions.
• The United States Surgical One-Shot system utilizes 10 or 12 nonpenetrating, arcuate-legged titanium clips for everted vessel or prosthetic conduit edges.

Purpose of the Study:

• To evaluate the efficacy and safety of a novel mechanical device for vascular anastomosis.
• To compare the physical properties of vascular constructs created by the device versus traditional suturing techniques.

Main Methods:

• The instrument was tested in animal models (20 pigs) for jugular and femoral vein grafts in carotid and femoral arteries.
• Human cadaveric constructs included saphenous veins to left anterior descending coronary arteries (20 cases) and brachiocephalic access fistulas (5 cases).
• Constructs were assessed for burst and tensile strength compared to 6-0 polypropylene sutured controls.

Main Results:

• Clipped vascular constructs demonstrated equivalent or superior physical properties (burst and tensile strength) compared to sutured controls.
• The device successfully created end-to-side vascular anastomoses in various animal and human cadaveric models.
• Studies adhered to Food and Drug Administration Good Laboratory Practice standards.

Conclusions:

• The device enables rapid and reproducible vascular anastomotic constructs, even in vessels as small as 1.8 mm outer diameter.
• The resulting vascular constructs are flanged, interrupted, and nonpenetrated.
• The device has received Food and Drug Administration approval for marketing.