Embosphere® Microspheres

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Feature & Benefits

Durable Occlusion

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

Compressible & 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.

Non-Aggregating Properties

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

Predictable Distribution

Because they are non-aggregating, Embosphere Microspheres distribute predictably after embolization.

Highly Targeted Delivery

Embosphere Microspheres are available in six 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.


CLINICALLY PROVEN ROUND EMBOLIC

Microsperes six month (A) and six years (B) after embolization of facial AVM

Microsperes six month (A) and six years (B) after embolization of facial AVM

A consistent cross-sectional diameter

A consistent cross-sectional diameter

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

 

“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)…”

Siskin GP, et al. Leiomyoma Infarction after Uterine Artery Embolization:
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


REGULATORY INFORMATION

USA

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

Embosphere Microspheres are indicated for use in the embolization of:

  • Hypervascular tumors, including symptomatic uterine fibroids
  • Prostatic arteries for symptomatic Benign Prostatic Hyperplasia (BPH)
  • Arteriovenous malformations
  • Blood vessels to occlude blood flow to control bleeding/hemorrhaging in the peripheral vasculature

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).

  • Most clinically studied round embolic
  • Backed by more than 200 clinical articles1—far more than all other round embolics combined
  • Consistent and durable clinical results with over 10 years of clinical experience
  • Technology used in over 340,000 procedures worldwide1

Data as of January 2016

 

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