Impella

Source: Wikipedia, the free encyclopedia.

Impella is a family of medical devices used for temporary

ECMO and Centrimag.[1]

The device is approved for use in high-risk

right heart via the ascending aorta or pulmonary artery
.

The Impella technology was acquired by Abiomed in 2005.[3] As of March 2019, the Impella series includes: the Impella 2.5, Impella 5.0/LD, Impella CP and Impella RP.[4][5][6]

Medical uses

The Impella device is an alternative for

physiologic mismatch in perfusion between left- and right-sided heart failure is in experimental status.[citation needed
] However, recent studies point to significantly greater in-hospital risks of major bleeding, death, and other adverse events for patients supported by Impella devices, compared with those managed with an IABP.[7] A propensity-matched comparison of patients receiving mechanical circulatory support (MCS) for myocardial infarction–related shock saw a nearly one-third excess in mortality and almost a doubling in risk of major bleeding, both in-hospital endpoints, with use of Impella compared to IABP. Impella may provide some of the results similar to venoarterial extracorporeal life support and TandemHeart.[8]

In patients with acute myocardial infarction complicated by cardiogenic shock,

haemodynamic support with the Impella device had no significant effect on thirty-day mortality as compared with IABP.[9]
Overall outcomes in the population, regardless of MCS device, were significantly worse for patients after the 2008 approval of Impella.[clarification needed] Among hospitals using Impella, those using it the most had significantly worse outcomes with Impella than those using it the least.[citation needed]

Potential complications related to the use of Impella are device related,[

mitral valve regurgitation.[10]

Technology

Impella heart pumps are percutaneous microaxial pumps that act as mechanical circulatory support devices in patients in need of hemodynamic support.[11] The pumps are mounted on support catheters and typically inserted through the femoral artery, although axillary and subclavian artery approaches are not uncommon.[12]

The Impella Device is a generational extension of the Intra aortic balloon pump (IABP) in addressing cardiogenic shock. Tech has allowed a single moving piece floated by magnetically steered mechanisms to deploy an "Archimedes Pump" just north of the Aortic Valve that purports to reduce both preload and afterload. The same tech can apparently also be deployed just above the pulmonary (pulmonic) valve as a gate on right sided heart failure.

Left-sided support

Designed to provide hemodynamic support when the patient's heart is unable to produce sufficient

pulmonary capillary wedge pressure and reduces right ventricular afterload.[19][20][21]

Approval

Impella was approved for mechanical circulatory support in 2008, but large-scale, real-world data on its use are lacking. In June 2008, the Impella 2.5 heart pump received

premarket approval for elective and urgent high-risk percutaneous intervention procedures.[23] In December 2016, the premarket approval was expanded to include the Impella CP heart pump.[24]

In April 2009, the Impella 5.0 and Impella LD heart pumps received 510(k) clearance for circulatory support for periods of up to six hours during cardiac procedures not requiring cardiopulmonary bypass.

medical transport.[26]

In January 2015, the Impella RP was granted a

right heart failure.[27]

In February 2018, the FDA approved the sale of the Impella ventricular support systems.[5]

Deaths and strokes in the data base overall increased after the Impella gained regulatory approval in 2008, compared to earlier years; mortality went up 17% and strokes more than tripled.[28]

In July 2023, the FDA issued a Class I recall for all Impella left-sided blood pumps due to risk of motor damage after contact with a transcatheter aortic valve replacement stent.[29][30]

In March 2024, the FDA issued a warning about Impella left-sided blood pumps being linked to 49 deaths due to left ventricular perforation or wall rupture.[31][32]

See also

References

  1. PMID 28388392
    .
  2. PMID 27660567
    .
  3. ^ "How Abiomed became a major medical device company". 10 October 2017.
  4. ^ "Explore Impella® Technology for Heart Recovery".
  5. ^ a b "Impella Ventricular Support Systems - P140003/S018". www.fda.gov. Archived from the original on 2018-04-24.
  6. ^ "Stocks". Bloomberg News.
  7. S2CID 208143531
    .
  8. PMID 27647331
    .
  9. PMID 31218000
    .
  10. S2CID 230818477
    .
  11. S2CID 240153209
    .
  12. PMID 27430667
    .
  13. ^ "Impella".
  14. ^
    PMID 18001394
    .
  15. ^
    PMID 19007597
    .
  16. S2CID 20486030
    .
  17. PMID 12679206
    .
  18. S2CID 36884928
    .
  19. S2CID 41290964
    .
  20. PMID 21423467
    .
  21. PMID 19617601
    .
  22. ^ "FDA 510(k) clearance". Food and Drug Administration. 31 August 2021.
  23. ^ "FDA approves blood pump system to help patients maintain stable heart function during certain high-risk cardiac procedures [press release]. Rockville, MD: US Food and Drug Association. March 23, 2015. Updated March 27, 2015". Food and Drug Administration.
  24. ^ "FDA approves blood pump system to help patients maintain stable heart function during certain high-risk cardiac procedures [press release]. Rockville, MD: US Food and Drug Association. March 23, 2015. Updated March 27, 2015". Food and Drug Administration.
  25. ^ "US Food and Drug Association. 510(k) Summary – Impella 5.0" (PDF).
  26. ^ "US Food and Drug Association. 510(k) Summary – Impella Controller" (PDF).
  27. ^ "Humanitarian Device Exemption (HDE). US Food and Drug Administration".
  28. S2CID 208143531
    .
  29. ^ "FDA Announces Class I Recall of All Left-Sided Impella Pumps". HCP Live. 2023-07-27. Retrieved 2024-03-29.
  30. ^ "Abiomed's latest Impella recall linked to 129 injury, 49 death reports". MedTech Dive. Retrieved 2024-03-29.
  31. ^ "FDA Warns About Impella Left-Sided Blood Pumps, Linked to 49 Deaths". HCP Live. 2024-03-29. Retrieved 2024-03-29.
  32. ^ "Abiomed Impella 'Instruction for Use' Recall Linked to 49 Deaths". www.mddionline.com. Retrieved 2024-03-29.
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