Embosphere
Features & Benefits

Embosphere® Microspheres are the most clinically studied and clinically proven round embolic, providing consistent and predictable results for controlled and effective embolization.

Regulatory Information

USA

Embosphere® Microspheres are indicated for use in embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.

European Union

Embosphere® Microspheres are indicated for use in hemostatic embolization and in embolization of arteriovenous malformations, hypervascular tumors, including uterine fibroids and meningiomas, and the prostate arteries for relief of symptoms related to Benign Prostatic Hyperplasia (BPH).

Embosphere® Microspheres are:

PREDICTABLE – Embosphere® Microspheres temporarily compress up to 33% for smooth microcatheter passage(A). Once through the microcatheter, they return to their original spherical shape and stated diameter (B) for predictable, reliable delivery.1

TARGETED – Embosphere® Microspheres have consistently demonstrated a direct correlation between the level of arterial occlusion and size of the microsphere used/injected.2-4  This unique feature gives physicians control over the embolization process.

ESTABLISHED – Embosphere® Microspheres have an extensive history, with more than 20 years of clinical use and over 250 clinical articles.5

Percentage of Patients with Complete Infarction Rates of Overall Uterine Fibroid Tumor Burden

With Embosphere® Microspheres, 92.3% of patients experienced 100% infarction of their entire uterine fibroid burden. Complete infarction of all fibroids leads to better long-term clinical outcomes, including a higher rate of symptom control and a lower rate of additional gynecologic intervention compared with incomplete infarction of fibroid tissue.9 

Durable Occlusion

Embosphere® Microspheres are biocompatible and nonresorbable with cell adhesion properties for complete and durable mechanical occlusion.

embosphere-resilience

Compressible and Resilient Material

Elastic properties allow temporary compression of up to 33%, facilitating smooth microcatheter passage. Resilient material returns to stated diameter after delivery, contributing to durable and targeted results.

embosphere-shape

Embosphere® Microspheres exhibit a consistent cross-sectional diameter for targeted delivery. Their round shape matches the vessel lumen to help ensure occlusion.

Non-Aggregating Properties

The hydrophilic surface and spherical shape of Embosphere® Microspheres prevent aggregation in the catheter lumen and vasculature.

Highly Targeted Delivery

Embosphere® Microspheres are available in seven size ranges to allow physicians to target the microvasculature of the tumor and shut down the feeder network while maintaining patency of the major artery feeding the organ.

The Clinically Proven Round Embolic

“Given the known risk of recurrence in patients with persistent tumor enhancement after UAE, it is concluded that tris-acryl gelatin microspheres should be the preferred agent for UAE at this time.”

Siskin GP, et al. Leiomyoma Infarction after Uterine Artery Embolization:
A Prospective Randomized Study Comparing Tris-acryl Gelatin Microspheres versus Polyvinyl Alcohol Microspheres. J Vasc Interv Radiol 2008; 19: 58-65.

“The primary embolic agent used was calibrated microspheres in 73% of cases (either Embosphere or Embosphere Gold, Biosphere Medical, Rockland, MA)…”

Worthington-Kirsch R, et al. The Fibroid Registry for Outcomes Data (FIBROID) for Uterine Embolization – Short Term Outcomes. Obstet & Gynecol 2005; 106: 52-9.

“[Patients] treated with TAGM were significantly more likely to have complete infarction of all leiomyomas…The use of spherical PVA particles in the manner described herein results in an unacceptably high rate of failed tumor infarction in UAE.”

Spies JB, et al. Spherical Polyvinyl Alcohol Versus Trisacryl Gelatin Microspheres for Uterine Artery Embolization for Leiomyomas: Results of a Limited Randomized Comparative Study. J Vasc Interv Radiol 2005;16:1431-7.

“Over the long term, UFE using TAGM is effective and safe, with high levels of durable symptom control, improved health-related quality of life and patient satisfaction.”

Spies JB, et al. Long-Term Outcome from Uterine Fibroid Embolization Using Tris-Acryl Gelatin Microspheres. J Vasc Interv Radiol 2007; 18: 203-7
If you think you are a candidate for Uterine Fibroid Embolization (UFE), please refer to ask4ufe.com for more information.

REFERENCES

  1. Laurent, et al. Trisacryl Gelatin Microspheres for Therapeutic Embolization, I: Development and In Vitro Evaluation. Am J Neuroradial. 1996 Mar; 17:533-540
  2. Pelage JP, et al. Uterine Artery Embolization in Sheep: Comparison of Acute Effects with Polyvinyl Alcohol Particles and Calibrated Microspheres. Radiol. 2002;224:436-45
  3. Verret V, et al. The Arterial Distribution of Embozene and Embosphere Microspheres in Sheep Kidney and Uterus Embolization Models. J Vasc Interv Radiol. 2011 Feb;22(2):220-8
  4. Laurent A, et al. Location of Vessel Occlusion of Calibrated Tris-acryl Gelatin Microspheres for Tumor and Arteriovenous Malformation Embolization. J Vasc Interv Radiol 2004; 15:491–4962004
  5. Data on file
  6. Siskin G, et al. Leiomyoma Infarction after Uterine Artery Embolization: A Prospective Randomized Study Comparing Tris-acryl Gelatin Microspheres versus Polyvinyl Alcohol Microspheres. J Vasc Interv Radiol. 2008; 19:42-46
  7. Smeets AJ, et al. Embolization of Uterine Leiomyomas with Polyzene F-coated Hydrogel Microspheres: Initial Experience. J Vasc Interv Radiol. 2010 Dec;21(12):1830-4
  8. Chrisman HB, et al., Prospective Evaluation of the Embolic Agent Bead Block in the Treatment of Uterine Leiomyomas with Uterine Artery Embolization. J Vasc Interv Radiol. 2010 Apr;21(4):484-9
  9. Katsumori T, et al. Infarction of Uterine Fibroids After Embolization: Relationship Between Postprocedural Enhanced MRI Findings and Long-Term Clinical Outcomes. Cardiovasc Intervent Radiol. 2008;31:66
Documents
Ordering Information

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Catalog NumberExpanded Family NameSize RangeDelivery SystemDelivery System SizeColorCarrier SolutionVolumeHCPCS CodeGS1GTIN UnitGTIN CartonGTIN Shipper
S1010GHEmbosphere® Microspheres900-1200 µmSyringe20 mLPurpleNormal Saline1.0 mL11516008844501151691088445011516620884450115163
S1020GHEmbosphere® Microspheres900-1200 µmSyringe20 mLPurpleNormal Saline2.0 mL10951008844501095191088445010951620884450109513
S120GHEmbosphere® Microspheres40-120 µmSyringe20 mLOrangeNormal Saline2.0 mL11422008844501142231088445011422020884450114227
S210GHEmbosphere® Microspheres100-300 µmSyringe20 mLYellowNormal Saline1.0 mL09856008844500985611088445009856820884450098565
S220GHEmbosphere® Microspheres100-300 µmSyringe20 mLYellowNormal Saline2.0 mL11062008844501106211088445011062820884450110625
S410GHEmbosphere® Microspheres300-500 µmSyringe20 mLBlueNormal Saline1.0 mL09842008844500984241088445009842120884450098428
S420GHEmbosphere® Microspheres300-500 µmSyringe20 mLBlueNormal Saline2.0 mL11629008844501162961088445011629320884450116290
S610GHEmbosphere® Microspheres500-700 µmSyringe20 mLRedNormal Saline1.0 mL10985008844501098541088445010985120884450109858
S620GHEmbosphere® Microspheres500-700 µmSyringe20 mLRedNormal Saline2.0 mL11671008844501167151088445011671220884450116719
S810GHEmbosphere® Microspheres700-900 µmSyringe20 mLGreenNormal Saline1.0 mL10605008844501060511088445010605820884450106055
S820GHEmbosphere® Microspheres700-900 µmSyringe20 mLGreenNormal Saline2.0 mL10475008844501047501088445010475720884450104754
V1010GHEmbosphere® Microspheres900-1200 µmVial5 mLPurpleNormal Saline1.0 mLNo Applicable Code08923008844500892311088445008923820884450089235
V1020GHEmbosphere® Microspheres900-1200 µmVial5 mLPurpleNormal Saline2.0 mLNo Applicable Code08922008844500892241088445008922120884450089228
V110GHEmbosphere® Microspheres40-120 µmVial5 mLOrangeNormal Saline1.0 mLNo Applicable Code08933008844500893301088445008933720884450089334
V120GHEmbosphere® Microspheres40-120 µmVial5 mLOrangeNormal Saline2.0 mLNo Applicable Code08932008844500893231088445008932020884450089327
V210GHEmbosphere® Microspheres100-300 µmVial5 mLYellowNormal Saline1.0 mLNo Applicable Code08931008844500893161088445008931320884450089310
V220GHEmbosphere® Microspheres100-300 µmVial5 mLYellowNormal Saline2.0 mLNo Applicable Code08930008844500893091088445008930620884450089303
V410GHEmbosphere® Microspheres300-500 µmVial5 mLBlueNormal Saline1.0 mLNo Applicable Code08929008844500892931088445008929020884450089297
V420GHEmbosphere® Microspheres300-500 µmVial5 mLBlueNormal Saline2.0 mLNo Applicable Code08928008844500892861088445008928320884450089280
V610GHEmbosphere® Microspheres500-700 µmVial5 mLRedNormal Saline1.0 mLNo Applicable Code08927008844500892791088445008927620884450089273
V620GHEmbosphere® Microspheres500-700 µmVial5 mLRedNormal Saline2.0 mLNo Applicable Code08926008844500892621088445008926920884450089266
V810GHEmbosphere® Microspheres700-900 µmVial5 mLGreenNormal Saline1.0 mLNo Applicable Code08925008844500892551088445008925220884450089259
V820GHEmbosphere® Microspheres700-900 µmVial5 mLGreenNormal Saline2.0 mLNo Applicable Code08924008844500892481088445008924520884450089242