A study of 21,848 non-emergent, high-risk patients who underwent PCI with PVADs, including Impella® heart pumps, demonstrates the PVAD patients had a lower rate of mortality and complications than patients who underwent PCI with IABPs.
This FAQ discusses the PROTECT series of FDA clinical studies, which include the PROTECT I study, the PROTECT II randomized controlled trial, and the PROTECT III study.
This FAQ explains how the conclusion of Amin et al. conflicts with more robust, previously published, FDA-audited, peer-reviewed, real-world studies and RCTs.
This FAQ explains how the conclusions of Dhruva et al. conflict with Impella® best practice outcomes reported in more robust, previously published, contemporary, prospective studies.
This FAQ discusses bleeding rates associated with mechanical circulatory support and vascular access and closure techniques for successfully managing bleeding.
This FAQ discusses the causes, incidence, and diagnosis of right heart failure and how the Impella RP with SmartAssist heart pump can support the right side of the heart.
The STEMI DTU pivotal trial is a prospective, multicenter, two-arm randomized controlled trial that plans to enroll 668 patients undergoing treatment for a STEMI heart attack.
A preponderance of evidence from the FDA cVAD Study, Impella Quality Database and the physician-initiated NSCI study supports the recommendation that placing Impella 2.5® or Impella CP® pre-PCI improves outcomes.
The NCSI Study is based on adopting the best practices algorithm focused on identifying shock early and unloading using Impella devices before PCI, reducing use of inotropes, and the use of invasive hemodynamic monitoring to aid in escalation and weaning.
The STEMI DTU pilot trial demonstrated for the first time that LV unloading using the Impella CP® heart pump with a 30-minute delay before reperfusion is safe and feasible
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