The Duett closure device: concept and experimental results

Area of Science:

• Biomedical Engineering
• Vascular Surgery
• Hemostasis Research

Background:

• Percutaneous vascular procedures carry risks of bleeding.
• Effective hemostasis is crucial for patient safety and successful outcomes.
• Novel devices are needed to improve bleeding control, especially in anticoagulated patients.

Purpose of the Study:

• To evaluate the hemostatic efficacy of a novel vascular sealing device.
• The device combines a balloon catheter with a procoagulant agent.
• Assess performance in canine femoral arteries, including anticoagulated models.

Main Methods:

• Vascular sheaths were inserted into canine femoral arteries.
• The device was tested with a balloon catheter alone (n=6).
• The device with balloon catheter and procoagulant was tested (n=21).
• Hemostasis was assessed, including in anticoagulated animals compared to controls.

Main Results:

• The balloon catheter alone achieved immediate hemostasis in all 6 cases.
• The device with procoagulant achieved 95% hemostasis (20/21 attempts).
• In anticoagulated dogs, the device achieved hemostasis in 6.5 +/- 3.4 minutes versus controls (p < 0.001).

Conclusions:

• The novel vascular sealing device demonstrates significant hemostatic capabilities.
• It provides rapid and effective bleeding control following percutaneous vascular interventions.
• The device shows promise for use in both normal and anticoagulated patients.