SEARCHSITE

ANGIO-SEAL FAMILY

MYDOCUMENTS

ANGIO-SEAL™ CLINICAL EVIDENCE

Clinical Evidence for Angio-Seal Vascular Closure Devices

More than 700 published clinical manuscripts establish the following benefits of our Angio-Seal vascular closure devices:

  • Improved patient comfort1
  • Decreased nursing time, improved turnaround time and better throughput in cath labs2,3
  • Opportunity for same-day discharge4
  • Lowered complication rates following percutaneous coronary interventions (PCIs) and diagnostic  procedures, including:
    • Groin hematoma5
    • Groin bleeding5
    • Femoral pseudoaneurysm5
    • Lower limb ischemia / arterial stenosis5

REDUCED BLEEDING COMPLICATIONS, IMPROVED OUTCOMES

A recent analysis of bleeding-avoidance strategies for patients undergoing PCIs involved the use of various vascular closure devices, including Angio-Seal™ vascular closure devices. The results suggest that determining a bleeding-management strategy for high-risk patients may improve the safety and cost-effectiveness of PCIs.6 The study reported that vascular closure devices were associated with a 23 percent reduction in bleeding rates—a significant reduction compared to manual compression.6

angio-seal Clinical Evidence Table

LOW COMPLICATION RATES

Failed closure is a leading predictor of vascular complications.7 Angio-Seal vascular closure devices demonstrate high success rates and low complication rates:8

  • 99.7 percent deployment success8
  • 97.8 percent hemostasis by device8
  • Multiple studies confirm its safety profile7,8

REFERENCES

1. Duffin, D. C., Muhlestein, J. B., Allisson, S. B., Horne, B. D., Fowles, R. E., Sorenson, S. G., … Lappe, D. L. (2001). Femoral arterial puncture management after percutaneous coronary procedures: A comparison of clinical outcomes and patient satisfaction between manual compression and two different vascular closure devices. Journal of Invasive Cardiology13(5), 354-362. http://www.ncbi.nlm.nih.gov/pubmed/11385148
2. Copelen, K. (2000). Improving productivity with the Angio-Seal device. Cath Lab Digest, Suppl:4-6. http://www.sjm.com/~/media/pro/products/vas/a-f/angio-seal-evolution/materials/cor09cvdxxxxen1_angio-seal_improving_productivity_clinical_highlights.ashx
3. Moran T. (2001). Increased throughput, staff efficiencies and patient comfort with the use of the Angio-Seal device. Cath Lab Digest, Suppl:16-18.
4. Patel, M., Kim, M., Karajgikar, R., Kodali, V., Kaplish, D., Lee, P., … Kini, A. (2010). Outcomes of patients discharged the same day following percutaneous coronary intervention. Journal of the American College of Cardiology: Cardiovascular Interventions3(8), 851-858. http://dx.doi.org/10.1016/j.jcin.2010.05.010
5. Arora, N., Matheny, M. E., Sepke, C., & Resnic, F. S. (2007). A propensity analysis of the risk of vascular complications after cardiac catheterization procedures with the use of vascular closure devices. American Heart Journal153(4), 606-611. http://www.ncbi.nlm.nih.gov/pubmed/17383300
6. Marso, S. P., Amin, A. P., House, J. A., Kennedy, K. F., Spertus, J. A., Rao, S. V., … Rumsfeld, J. S. (2010).Association between use of bleeding avoidance strategies and risk of periprocedural bleeding among patients undergoing percutaneous coronary intervention. Journal of the American Medical Association303(21), 2156-2164. http://dx.doi.org/10.1001/jama.2010.708
7. Applegate, R .J., Sacrinty, M. T., Kutcher, M. A., Kahl, F. R., Gandhi, S. K., Santos, R. M., & Little, W. C. (2008). Trends in vascular complications after diagnostic cardiac catherization and percutaneous coronary intervention via the femoral artery, 1998 to 2007. Journal of the American College of Cardiology: Cardiovascular Interventions1(3), 317-326. http://dx.doi.org/10.1016/j.jcin.2008.03.013
8. Applegate, R. J., Turi, Z., Sachdev, N., Ahmed, A., Szyniszewski, A., Foster, M., … Shavelle, D. (2010). The Angio-Seal Evolution registry: Outcomes of a novel automated Angio-Seal vascular closure device. Journal of Invasive Cardiology22(9), 420-426. https://www.ncbi.nlm.nih.gov/pubmed/20814049?dopt=Abstract

Indications:
The  Angio-Seal Vascular Closure Device product family, including the STS Plus, VIP and Evolution platforms, 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. The Angio-Seal STS Plus, VIP and Evolution platform devices are 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 a licensed physician (or other health care professional authorized by or under the direction of such physician) possessing adequate instruction in the use of the device, e.g., participation in an Angio-Seal physician instruction program or equivalent.

RX ONLY. Refer to the product labels and package insert for complete warnings, precautions, potential complications, and instructions for use.