Embolization products

X-Spheres™

INterface BIOmaterials B.V. has developed a proprietary new product for the embolization of uterine fibroids. The product is called X-Spheres™. CE certification was obtained in the spring of 2013. The distinguishing unique feature of the X-Spheres™ is that the embolizing spherical microparticles are not only biocompatible, but also radio-opaque. The spherical microparticles can be visualized through X-ray fluoroscopy, i.e. during the embolization procedure, and also afterwards. This feature will contribute to the efficacy and safety of embolization procedures.

Product Description

X-Spheres™ contains size-calibrated, biocompatible, yellow-tinted, non-resorbable and radiopaque polymer microspheres, to be used as embolization particles in the treatment of uterine fibroids (also called: uterine leiomyomas). X-Spheres™ is available in various versions, which differ with respect to the diameter range of the microspheres:

Size range Microspheres
per syringe (mg)
Injection
fluid (mL)
Product code
400 – 600 µm 200 8 901130
600 – 710 µm 200 8 901135
710 – 850 µm 200 8 901150

 

X-Spheres™ is presented as:

  • Prefilled syringe of 20 mL
  • Syringe is filled with microspheres (200 mg) suspended in 8 mL biocompatible non-pyrogenic sterile injection fluid
  • Syringe is packed in a sterile, sealed pouch
  • Labels on the box, pouch and syringe indicate the specific diameter range of the microspheres contained in the syringe

Indications

X-Spheres™ is indicated for embolization of symptomatic uterine fibroids (uterine leiomyomas). These are benign tumors of the smooth muscle cells found in the human uterus. They are the most common benign tumors in women. Recent studies have estimated that the lifetime risk of fibroids in a woman over the age of 45 years is > 60 % . The incidence is much higher in blacks than in whites. Uterine fibroids cause pain, pressure symptoms, heavy prolonged bleeding, and diminished fertility.

Therapeutic options include myomectomy (laparoscopic removal of the fibroids) or hysterectomy (surgical removal of the uterus + fibroids). These are the most common treatment methods. Uterine artery embolization (UAE), which is a modern minimally invasive approach, is becoming of greater interest to patients, physicians and to the healthcare system. UAE is an effective treatment catheter-based technique: it is a validated alternative to myomectomy and hysterectomy that must be offered to patients. Embolization is cheaper than hysterectomy at 12 and 24 months even taking into consideration the additional costs of imaging and re-interventions.

UAE is a good alternative treatment for women with a unique fibroid of less than 10 cm, or multiple fibroids around 15 cm. At 6 months, fibroids are shrunk by 50 – 80 % in volume. Symptoms usually disappear. There is a high level of patient satisfaction (> 85 %) with significant improvement in quality-of-life measures. Hospital stay, duration of recovery and time off work are shorter after embolization compared to hysterectomy. This treatment should be proposed to women each time possible. After UAE, recurrence of fibroids is rare, and usually due to growth of new fibroids, not due to regrowth of infracted fibroids.

X-Spheres™ are supplied by our distributor “Rembrandt Medical B.V.”  REQUEST  A QUOTE 

  • Distributor information

    Rembrandt Medical B.V.

    Vlierberg 7

    3755 BS Eemnes

    The Netherlands

    www.rembrandt.nl