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PROCEDURAL SOLUTIONS

Vascular Access and Closure Devices

Terumo’s portfolio offers a full range of access and closure solutions uniquely engineered to achieve the best possible outcomes.

Terumo Access Devices

Radial Access

Femoral Access

Tibial Pedal Access

Terumo Closure Devices

Radial Closure

Femoral Closure

INDICATIONS

The Angio-Seal Vascular Closure Device is indicated for use in closing and reducing time to hemostasis of the femoral arterial puncture site in patients who have undergone diagnostic angiography procedures or interventional procedures using an 8 French or smaller procedural sheath for the 8 F Angio-Seal device and a 6 French or smaller procedural sheath for the 6 F Angio-Seal device. Angio-Seal is also indicated for use to allow patients who have undergone diagnostic angiography to safely ambulate as soon as possible after sheath removal and device placement, as well as to allow patients who have undergone an interventional procedure to safely ambulate after sheath removal and device placement.

IMPORTANT SAFETY INFORMATION

Possible adverse events for vascular closure devices include, but are not limited to: bleeding or hematoma, AV fistula or pseudoaneurysm, infection, allergic reaction, foreign body reaction, inflammation or edema. This device should only be used by physicians with training qualifying them to perform arterial access and closure for endovascular procedures through the common femoral artery and have participated in a Terumo Medical Corporation Angio-Seal physician instruction program. 

References

RX ONLY. This advertisement is directed to physicians only, and not to consumers.  Refer to the product labels and package insert for complete warnings, precautions, potential complications, and instructions for use. 

1. Saito S, et al. Influence of the ratio between radial artery inner diameter and sheath outer diameter on radial artery flow after transradial coronary intervention. Cath Cardio Interv. 1999;46:173-178.

2. Pancholy S. Prevention of radial artery occlusion—patent hemostasis evaluation trial (PROPHET Study): A randomized comparison of traditional versus patency documented hemostasis after transradial catheterization. Cath Cardio Interv. 2008;72:335-340.

3. Dahm J, et al. A Randomized Trial of 5 vs. 6 French Transradial Percutaneous Coronary Interventions. Cath Cardio Interv. 2002;57:172–176.

4. Data on file. Terumo Medical Corporation. TIF Engineering Evaluation and Test Production Results #20070045. 

5. Data on file. Terumo Medical Corporation. Pinnacle Precision Access System Competitor Evaluation Report #20170018.

6. Ono K. Experience of the TR BAND for the Diagnostic Catheter Procedure. Yuri Union General Hospital in Akita Pref., September 2004.

7. Kapadia SR, Raymond R, Knopf W, et al. Am J Cardiol. 2001;87:789-791.

8. Nash JE, Evans DG. Herz. 1999;24(8):597-606. http://dx.doi.org/10.1007/bf03044483.

9. Angio-Seal VIP VCD Instructions for Use.