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FlexHD
FlexHD is a flexible hemodynamic support device designed to provide temporary mechanical circulatory support.
FlexHD is a flexible hemodynamic support device designed to provide temporary mechanical circulatory support. Used for Cardiogenic shock requiring temporary mechanical circulatory support, Acute decompensated heart failure.
At a glance
| Generic name | FlexHD |
|---|---|
| Sponsor | University of Arkansas |
| Modality | Biologic |
| Therapeutic area | Cardiovascular |
| Phase | FDA-approved |
Mechanism of action
FlexHD functions as a percutaneous ventricular assist device that can be rapidly deployed to support failing hearts during acute decompensation or cardiogenic shock. The device provides hemodynamic stabilization by mechanically unloading the left ventricle and improving systemic perfusion, allowing time for myocardial recovery or bridge to definitive therapy.
Approved indications
- Cardiogenic shock requiring temporary mechanical circulatory support
- Acute decompensated heart failure
Common side effects
- Bleeding
- Infection
- Thromboembolism
- Device malfunction
Key clinical trials
- FlexHD® Pliable Investigation in Implant-Based Breast Reconstruction (NA)
- A Retrospective Breast Reconstruction Study
- Use of FlexHD as Post Trapeziectomy Spacer (PHASE4)
- Reconstruction Outcomes in Immediate Post-mastectomy Breast Reconstruction With ADM (NA)
- Dermacell ADM Without Basement Membrane (NA)
- Comparison of FlexHD and Alloderm Outcomes in Breast Reconstructive Surgery (PHASE4)
- Comparative Effectiveness Multicenter Trial for Adhesion Characteristics of Ventral Hernia Repair Mesh
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- FlexHD CI brief — competitive landscape report
- FlexHD updates RSS · CI watch RSS
- University of Arkansas portfolio CI