Tridyne™ Vascular Sealant

* The use of Tridyne™ Vascular Sealant with ePTFE grafts or vascular patches has not been studied clinically. Preclinical data on file. Preclinical test results may not correlate to clinical performance.

1. Khoynezhad A, DelaRosa J, Moon M, et al. Facilitating Hemostasis After Proximal Aortic Surgery: Results of The PROTECT Trial. Ann Thorac Surg. 2018;105(5):1357-1364.

2. BD Inc. In vitro testing. Data on file. Preclinical test results may not correlate to clinical performance.

3. Tridyne™ Vascular Sealant is indicated for use in aortic surgery when adjunctive measures to achieve hemostasis are required by mechanically sealing areas of leakage.

4. One subject from the Gelfoam® Plus treatment group required a reoperation for aortic bleeding complications following completed surgery through 30 days.

5. Mean time to hemostasis was 2.07 minutes for the Tridyne™ Vascular Sealant treatment group and 6.3 minutes for the Gelfoam® Plus control treatment group (P < 0.0001).

Indications

Tridyne™ Vascular Sealant (Tridyne™ VS) is indicated for use in aortic surgery when adjunctive measures to achieve hemostasis are required by mechanically sealing areas of leakage.

Contraindications

Tridyne™ VS is not for intravascular use. Do not use Tridyne™ VS in patients who have a history of allergic reaction to Human Serum Albumin, Polyethylene Glycol, or other device components. Do not apply Tridyne™ VS on oxidized regenerated cellulose, absorbable gelatin sponges, or any other surface or material other than the target tissue or graft as adherence and intended outcome may be compromised. Do not use Tridyne™ VS in patients who have insufficient renal capacity for clearance of the Polyethylene Glycol load.

Warnings

Do not use Tridyne™ VS as a substitute for standard closure techniques. Excessive pressure against the vessel/graft edges or surrounding tissue during application may result in separation of the vessel/graft edges, allowing sealant into the vessel.

Do not apply Tridyne™ VS when the vessel lumen is under negative pressure to avoid product from being drawn into the vessel (e.g., avoid applying in vessels that are not pressurized).

Do not use more than 30 mL of Tridyne™ VS per patient. Do not allow non-polymerized Tridyne™ VS to contact circulating blood.

Adverse Events

In a pivotal clinical trial, approximately half of the subjects in each treatment group experienced a Serious Adverse Event while in the study (51 subjects [48.1%] treated with Tridyne™ VS, 29 subjects [58.0%] treated with Control). Three Serious Adverse Events in the treatment group were considered by the Clinical Events Committee to be possibly device-related. These Serious Adverse Events included: cerebrovascular accident and serosanguineous pericardial effusion. None of the Serious Adverse Events were unexpected given the procedures performed. The details of these clinical trial adverse events can be reviewed in the Instructions for Use supplied with the product and are also available at www.bd.com. Caution: Federal (USA) law restricts this device to sale by or on order of a licensed physician or properly licensed practitioner.