HYDROPEARL® MICROSPHERES

PRODUCT OVERVIEW

DESIGNED FOR CONTROLLED AND TARGETED EMBOLIZATION

UNIQUE FORMULATION

HydroPearl® Microspheres are the first and only Polyethylene Glycol (PEG) microspheres. They are engineered for accurate embolization at the target area.1,2

TIGHT CALIBRATION

HydroPearl® is available in a range of sizes from 75 μm to 1100 μm with a tighter size distribution*.

This precise calibration may allow more predictable and targeted embolization 1,2**

AVAILABLE IN 6 DISTINCT, COLOR-CODED SIZES

* 90% or higher of HydroPearl sizes are within specification as indicated on the labels.
** Calibration data is 6 lots per each size of randomly selected HydroPearl with 1 lot of competitive products. Sampling done at minimum 150 microspheres per syringe.

HydroPearl Video – Suspension

HydroPearl Video – Calibration

HydroPearl Video – Robustness

 

HydroPearl® microspheres are intended for the embolization of: 3,4

  • Hypervascular tumors
  • Symptomatic uterine fibroids
  • Arteriovenous malformations (AVMs)
  • Prostatic Arteries (PAE) for symptomatic benign prostatic hyperplasia (BPH)

IN-SERVICE VIDEO

PRODUCT CODES

HYDROPEARL® Microspheres

HYDROPEARL SIZES (μm) PRODUCT CODES VOLUME OF
MICROSPHERES (ml)
MICROSPHERE
COLOR
75 ± 30 μm HP2S0075 2 Orange
200 ± 75 μm HP2S0200 2 Yellow
400 ± 75 μm HP2S0400 2 Blue
600 ± 75 μm HP2S0600 2 Red
800 ± 75 μm HP2S0800 2 Green
1100 ± 75 μm HP2S1100 2 Purple
*HydroPearl® microspheres are contained in a 20cc pre-filled syringe of sterile phosphate buffered saline (PBS) 3-year shelf life from date of manufacture

TERUMO CATHETER COMPATIBILITY1

HYDROPEARL SIZES (μm) PROGREAT® 2.0F PROGREAT® 2.4F PROGREAT® 2.7F PROGREAT® 2.8F GLIDECATH® 4.0F
75 ± 30 μm Compatible Compatible Compatible Compatible Compatible
200 ± 75 μm Compatible Compatible Compatible Compatible Compatible
400 ± 75 μm Compatible Compatible Compatible Compatible Compatible
600 ± 75 μm Non-Compatible Compatible Compatible Compatible Compatible
800 ± 75 μm Non-Compatible Non-Compatible Compatible Compatible Compatible
1100 ± 75 μm Non-Compatible Non-Compatible Non-Compatible Non-Compatible Compatible

 

DOCUMENTS

View HydroPearl® Brochure
View HydroPearl® Brochure
HydroPearl IFU
HydroPearl IFU
HydroPearl PAE Sell Sheet
HydroPearl PAE Sell Sheet
View Embolization Pocket Guide
View Embolization Pocket Guide
HydroPearl 510K
HydroPearl 510K

REFERENCES

RX ONLY. Refer to the product labels and package insert for complete warnings, precautions, potential complications, and instructions for use.

  1. Data on file.
  2. Karolin J. Paprottka et al. In vitro study of physical properties of various embolization particles regarding morphology before, during and after catheter passage. Clinical Hemorheology and Microcirculation. 1386-0291/16.
  3. Per Instructions For Use PD111835 Rev. A Revised 2017-08
  4. HydroPearl 510(k) Letter. 22 Jan. 2020