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hydropearl microspheres
Microvention
Summary: HydroPearl Microspheres are embolic agents used primarily for embolization procedures. Key evidence highlights their use in uterine fibroid and prostatic artery embolization with reported safety and efficacy.
FDA Clearance Information
Pathway
510K
Number
K192684 ↗
Decision Date
January 22, 2020
Product Code
NOY
Device Class
Class 2
Evidence
0 studies
HydroPearl Microspheres received FDA clearance through the 510(k) pathway on January 22, 2020. Manufactured by Microvention, they are classified as Class 2 devices.
What It Is
HydroPearl Microspheres are embolic agents designed for use in embolization procedures. They are composed of polyethylene glycol and are intended to occlude blood vessels in various clinical applications.
Clinical Applications
Common clinical scenarios for HydroPearl Microspheres include uterine artery embolization for symptomatic 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 nine studies, comprising retrospective and prospective designs, published between 2021 and 2025. These studies evaluate the efficacy and safety of HydroPearl Microspheres in various embolization procedures.
Reported Outcomes
Published studies report that HydroPearl Microspheres are effective in reducing symptoms associated with uterine fibroids and benign prostatic hyperplasia. They also demonstrate efficacy in genicular artery embolization for knee osteoarthritis, with improvements in patient-reported outcomes.
Safety Profile
Reported complications include short-term and long-term complications in uterine artery embolization. Safety profiles in prostatic artery embolization indicate a favorable outcome with minimal adverse events.
Evidence Limitations
Current evidence is limited by the lack of large-scale randomized controlled trials. 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 embolization procedures, including uterine fibroid embolization, prostatic artery embolization, and genicular artery embolization.
What outcomes have been reported in clinical studies?
Clinical studies report efficacy in symptom reduction for uterine fibroids and benign prostatic hyperplasia, as well as improvements in knee osteoarthritis symptoms.
What complications have been reported?
Safety data indicate short-term and long-term complications in uterine artery embolization, with minimal adverse events reported in prostatic artery embolization.
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.