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Initial experience with the Cardiva Boomerang vascular closure device in diagnostic catheterization
Brendan J Doyle1, Michael J Godfrey, Ryan J Lennon
1Division of Cardiovascular Diseases, Mayo Clinic, Rochester, Minnesota 55905, USA.
Insights
The Cardiva Boomerang device offers a safe and effective solution for vascular closure after cardiac catheterization. It enables early patient ambulation with minimal complications, even in challenging cases.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Vascular Surgery
Background:
- Conventional vascular closure devices are linked to serious complications like arterial occlusion and infection.
- These traditional devices have limitations, especially for patients with peripheral vascular disease or non-common femoral artery access.
- The Cardiva Boomerang device offers an alternative that leaves no foreign material and accommodates broader patient populations.
Purpose of the Study:
- To evaluate the safety and efficacy of the Cardiva Boomerang vascular closure device.
- To assess the device's performance in patients undergoing diagnostic cardiac catheterization via the transfemoral approach.
Main Methods:
- A study involving 96 patients undergoing transfemoral diagnostic cardiac catheterization.
- Included 25 patients with contraindications for conventional closure devices.
- Femoral angiography was performed before device deployment; patients ambulated 1 hour post-hemostasis.
Main Results:
- Successful deployment and hemostasis were achieved in 99% of patients using the Cardiva Boomerang device alone.
- One patient required conversion to manual compression due to device non-deployment.
- Only 5% of patients experienced minor complications, with no major adverse events reported.
Conclusions:
- The Cardiva Boomerang device is a safe and effective option for vascular closure in diagnostic cardiac catheterization.
- It facilitates early ambulation and demonstrates a low incidence of vascular complications.
- The device is suitable for a wide range of patients, including those with contraindications to conventional methods.
Objectives:
The authors studied the safety and efficacy of the Cardiva Boomerang vascular closure device in patients undergoing diagnostic cardiac catheterization.
Background:
Conventional vascular closure devices (sutures, collagen plugs, or metal clips) have been associated with catastrophic complications including arterial occlusion and foreign body infections; furthermore, they cannot be utilized in patients with peripheral vascular disease or vascular access site in a vessel other than the common femoral artery. The Cardiva Boomerang device facilitates vascular hemostasis without leaving any foreign body behind at the access site, can be used in peripheral vascular disease, and can be used in vessels other than the common femoral artery
Methods:
A total of 96 patients undergoing transfemoral diagnostic cardiac catheterization were included in this study, including 25 (26%) patients with contraindications to conventional closure devices. Femoral angiography was performed prior to deployment of the Cardiva Boomerang closure device. Patients were ambulated at 1 hr after hemostasis was achieved.
Results:
The device was successfully deployed and hemostasis achieved with the device alone in 95 (99%) patients. The device failed to deploy in 1 (1%) patient and required conversion to standard manual compression. Minor complications were observed in 5 (5%) patients. No patients experienced major complications including femoral hematoma > 4 cm, red blood cell transfusion, retroperitoneal bleed, arteriovenous fistula, pseudoaneurysm, infection, arterial occlusion, or vascular surgery.
Conclusions:
The Cardiva Boomerang device is safe and effective in patients undergoing diagnostic cardiac catheterization using the transfemoral approach, facilitating early ambulation with low rates of vascular complications.
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