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Tridyne™ Cardiovascular Sealant
Clinically proven to perform under pressure1
A strong elastic seal where it matters most
Tridyne™ Cardiovascular Sealant is the latest addition to the BD family of hemostasis solutions, offering cardiovascular, cardiothoracic, and vascular surgeons a unique, easy-to-use solution to reinforce aortic anastomoses and control bleeding when adjunctive measures are required. By combining a proprietary formulation of polyethelyne glycol and recombinant human albumin (rHA), it forms a strong, flexible seal, even in anticoagulated patients.1,2 The Tridyne™ hydrogel is designed to adhere where it should – on both tissue and grafts.*
Preclinical data demonstrates that Tridyne™ Cardiovascular Sealant resorbs naturally to maintain its seal strength through the critical postoperative period without compromising tissue healing.2
Precise, controlled application—made easy
Tridyne™ Cardiovascular Sealant provides application control without the need for pressurized gas.
The Tridyne™ applicator is designed to:
- Provide uniform, continuous coverage without clumping
- Control sealant application by varying hand pressure
- Easily transition from targeted application over the anastomosis to broader coverage to address more diffuse bleeding
Clarity and coverage
The specialized Tridyne™ formulation is transparent and forms a completely clear hydrogel at the application site. With its unique combination of clarity and coverage, Tridyne™ Cardiovascular Sealant allows for visual confirmation of hemostasis at the anastomotic suture line—making it an ideal choice for aortic surgery.
Performance under pressure
In a prospective, randomized, controlled multicenter study, Tridyne™ Cardiovascular Sealant outperformed Gelfoam® Plus Hemostasis Kit in several critical measures.6 The study included 156 patients from 18 different centers who underwent thoracic aortic surgery, with hemostasis evaluated at the aortic anastomotic suture line.1
The proven solution during aortic repair1
Tridyne™ Cardiovascular Sealant offers surgeons a specialized, easy-to-use solution during aortic repair, with unique application control and clinically proven results.1 With its demonstrated ability to provide fast, effective control of bleeding, it’s the sealant of choice for aortic surgery.
| SKU/REF | SKU/REF Name | Packaging |
|---|---|---|
| TDCV004 | Tridyne™ Cardiovascular Sealant (4 mL) | 4/cs |
Related Products
Please note, not all products, services or features of products and services may be available in your local area. Please check with your local BD representative.
* 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.
INTENDED USE / INDICATIONS FOR USE
Tridyne™ Cardiovascular Sealant is indicated for use as an adjunct to hemostasis for treatment of cardiovascular and peripheral vasculature diffuse persistent bleeding by mechanically sealing areas of leakage.
CONTRAINDICATIONS
- Do not use Tridyne™ in patients who have a history of an allergic reaction to recombinant albumin, yeast, or other device components.
- Do not use Tridyne™ for treatment of severe or active bleeding.
- Do not apply Tridyne™ on oxidized regenerated cellulose, absorbable gelatin sponges or any other surface or material other than the target tissue as adherence and intended outcome may be compromised.
- Do not use more than 30 ml of Tridyne™per patient and do not use in patients with compromised renal capacity for clearance of the Tridyne™ polyethylene glycol load.
WARNINGS
- Tridyne™ should be used only as described in these instructions for use.
- Tridyne™ should only be used with the delivery device provided in the kit.
- Inspect sterile package and seal prior to use. Do not use if sterile package or seal are damaged or open.
- This device is packaged and sterilized for single use only. Do not reuse or reprocess. Reuse or reprocessing may compromise the structural integrity of the device, and/or lead to device failure that in turn may result in patient injury, illness or death. Also, reprocessing of single use devices may create a risk of contamination and/or patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness, or death of the patient.
- Tridyne™ should be refrigerated between 2°C and 8°C (36°F to 46°F). Do not freeze. Store Tridyne™ within the recommended temperature range. Failure to do so may result in poor product performance. Do not use Tridyne™ after the expiration date, as sterility or performance may be compromised.
ADVERSE EVENTS
The following potential Adverse Events have been associated with this type of surgical sealant:
- A hypersensitivity reaction such as swelling or edema at the application site
- Thrombosis and thromboembolism
- An exacerbation of renal dysfunction in patients with pre-existing renal disease
- Failure of the sealant to adhere to target tissue
- Failure of the sealant to stop diffuse persistent bleeding
In addition, the following potential Adverse Events and Serious Adverse Events have been associated with cardiac and vascular procedures.
- Adhesions Lymphocele/
- Aneurysm and anastomotic pseudoaneurysm
- Aortic insufficiency
- Cardiac tamponade
- Cerebral emboli
- Coagulopathy
- Death or irreversible morbidity
- Edema
- Emboli
- Erythema
- Graft occlusion
- Hematoma
- Hemorrhage
- Infection
- Injury to normal vessels or tissue
- Ischemia
- lymph fistula
- Myocardial infarction
- Neurological deficits
- Organ system dysfunction/failure
- Pain
- Paraplegia
- Pleural effusion
- Pyrexia
- Renal dysfunction/failure
- Stroke or cerebral infarction
- Thrombosis
- Vasospasm
- Vessel dissection
- Vessel occlusion
- Vessel rupture and tissue hemorrhage
References
- 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. The cited study is referring to Tridyne™ Vascular Sealant. Based on the results of the pre-clinical studies, there are no differences in clinical outcomes between Tridyne™ Vascular Sealant and Tridyne™ Cardiovascular Sealant.
- BD Inc. In vitro testing. Data on file. Preclinical test results may not correlate to clinical performance.
- Tridyne™ Cardiovascular Sealant is indicated for use in aortic surgery when adjunctive measures to achieve hemostasis are required by mechanically sealing areas of leakage.
- One subject from the Gelfoam® Plus treatment group required a reoperation for aortic bleeding complications following completed surgery through 30 days.
- 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).
- Tridyne™ Vascular Sealant is not available in EU, its only difference with Tridyne™ Cardiovascular Sealant is that the latter is comprised of a proprietary combination of Recombinant human albumin (rHA) instead of human serum albumin (HSA) as the main component.
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