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hydropearl microspheres hydropearl microspheres
Microvention
Summary: HydroPearl Microspheres are embolic agents used in various embolization procedures. They are primarily used for uterine artery embolization and prostatic artery embolization. Key evidence highlights their efficacy and safety in treating symptomatic uterine fibroids and benign prostatic hyperplasia.
FDA Clearance Information
Pathway
510K
Number
K150870 ↗
Decision Date
December 21, 2015
Product Code
KRD
Device Class
Class 2
Evidence
0 studies
The HydroPearl Microspheres were cleared by the FDA via the 510(k) pathway on December 21, 2015. Manufactured by Microvention, they are classified as Class 2 medical devices.
What It Is
HydroPearl Microspheres are polyethylene glycol-based embolic agents designed for use in embolization procedures. They are intended to occlude blood vessels to treat various conditions, including uterine fibroids and benign prostatic hyperplasia.
Clinical Applications
Common clinical scenarios for HydroPearl Microspheres include uterine artery embolization for symptomatic uterine fibroids and prostatic artery embolization for benign prostatic hyperplasia. They are also used in genicular artery embolization for knee osteoarthritis.
Evidence Summary
The literature includes a mix of retrospective, prospective, and registry studies, with a total of 9 studies published between 2021 and 2025. These studies explore the use of HydroPearl in different embolization procedures.
Reported Outcomes
Published studies report that HydroPearl Microspheres are effective in reducing symptoms associated with uterine fibroids and benign prostatic hyperplasia. The studies highlight improvements in patient symptoms and quality of life post-embolization.
Safety Profile
Reported complications include short-term and long-term complications such as post-embolization syndrome and minor procedural complications. Overall, the safety profile is consistent with other embolic agents.
Evidence Limitations
The evidence is limited by the relatively small sample sizes and short follow-up periods in some studies. Further research is needed to establish long-term outcomes and comparative effectiveness against other embolic agents.
Frequently Asked Questions
What are the clinical indications for HydroPearl Microspheres?
HydroPearl Microspheres are indicated for use in embolization procedures such as uterine artery embolization for fibroids and prostatic artery embolization for benign prostatic hyperplasia.
What outcomes have been reported in clinical studies?
Studies report significant symptom relief and improved quality of life in patients undergoing embolization with HydroPearl Microspheres.
What complications have been reported?
Safety data indicate complications such as post-embolization syndrome and minor procedural issues, consistent with other embolic agents.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.