Bead Block™ Brief Summary

Indications, Safety and Warnings

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. Prior to use, please see the complete “Instructions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions.

INDICATIONS FOR USE

Bead Block Device is indicated for the embolization of hypervascular tumors (HVTs), including uterine fibroids (UFE) and arteriovenous malformations (AVMs). Bead Block Device is also indicated for embolization of prostatic arteries (PAE) for symptomatic benign prostatic hyperplasia (BPH).

Recommended Catheters and Contrast Agents

The beads have been tested and shown to be successfully delivered using the following combinations of bead size, contrast medium, and microcatheters shown in the table below.

Table 2. Recommended catheters and contrast agents

Size Range  Recommended Catheter (ID)   Recommended Contrast Agents 

100 μm – 300 μm

300 μm – 500 μm

500 μm – 700 μm

≥ 2.4F

(0.54 mm/0.021 in)

Omnipaque 300 (Iohexol 300)

Omnipaque 350 (Iohexol 350)

Visipaque 320 (Iodixanol 320)

Iomeron 350 (Iomeprol 350)

Niopam 300/Isovue 300

(Iopamidol 300)

Optiray 300 (Ioversol 300)

Niopam 370 (Iopamidol 370)

700 μm – 900 μm

 900 μm – 1,200 μm 

≥ 4F

(0.97 mm/0.038 in)

Note: Other contrast agents have not been tested in conjunction with the beads.

CONTRAINDICATIONS

  • Patients intolerant to occlusion procedures.
  • Vascular anatomy or blood flow that precludes catheter placement or injection of embolics.
  • Presence or likely onset of vasospasm.
  • Presence or likely onset of hemorrhage.
  • Presence of severe atherosclerosis or atheromatous disease.
  • Presence of feeding arteries smaller than distal branches from which they emerge.
  • Presence of patent extra-to-intracranial anastomoses or shunts.
  • Presence of collateral vessel pathways potentially endangering non-target tissue during embolization.
  • Presence of end arteries leading directly to cranial nerves.
  • Presence of arteries supplying the lesion/tumor not large enough to accept the beads.
  • Vascular resistance peripheral to the feeding arteries precluding passage of the beads into the lesion/tumor.
  • Do not use Bead Block Device in the following applications:
    • Embolization of large-diameter arteriovenous (AV) shunts (i.e., where the blood does not pass through the arterial/capillary/venous transition but directly from artery to vein).
    • Pulmonary arterial vasculature.
    • Any vasculature where the beads could pass directly into the internal carotid artery, the central circulatory system, or other nontarget territories

UFE-Specific Contraindications

  • Pregnant women.
  • Active or suspected pelvic inflammatory disease.
  • Malignancy of the pelvic region.
  • Endometrial neoplasia or hyperplasia.
  • Presence of submucosal fibroids with > 50 % growth into the uterine cavity.
  • Presence of pedunculated serosal fibroid as the dominant fibroid(s).
  • Fibroids with significant collateral feeding by vessels other than the uterine arteries.

PAE-Specific Contraindications

  • Presence of prostate cancer or bladder cancer.
  • Active prostatitis or urinary tract infection.
  • Chronic renal failure.
  • Other conditions that could cause prostatic or lower urinary tract symptoms or infection, such as any disorder impacting bladder function, bladder stones, or urinary obstruction due to causes other than BPH, including urethral stricture.

WARNINGS

The following warning statements provide important information for safe use of Bead Block Device. Observe all warnings provided in these instructions for use. Failure to do so may result in patient injury or product damage.

  • When prepared according to instructions, this product contains contrast, which may cause an allergic reaction for patients who may be allergic or with known sensitivity to contrast.
  • Studies have shown that the beads do not form aggregates, and, as a result, penetrate deeper into the vasculature as compared to similarly-sized PVA particles. Care must be taken to choose a larger-sized bead when embolizing AVMs with large shunts to avoid passage of the product into the pulmonary or coronary circulation.
  • Bead embolization must be performed slowly. The injection speed and manner must be controlled. Excessive injection rate may result in retrograde flow in the vessel, leading to embolization of other non-target healthy tissue or organs.
  • Monitor patients carefully for signs of non-target embolization, such as hypoxia or central nervous system (CNS)changes.
  • Patients with prior biliary surgery, bile duct dilation, or vessels close to bile ducts may be at increased risk from infection (e.g., biloma/liver abscess).

UFE-Specific Warnings

Warnings about UFE and Pregnancy

  • There are no long-term data on the effects of UFE on the ability to become pregnant and carry a fetus to term, and on the development of the fetus.
  • This procedure should only be performed on women who do not intend future pregnancy.
  • Women who become pregnant following UFE may be at increased risk for the following:
    • Postpartum hemorrhage.
    • Abnormal placentation.
    • Preterm delivery.
    • Cesarean delivery.
    • Abnormal presentation at birth.
  • Devascularization of the uterine myometrium resulting from UFE may increase the risk of uterine rupture of women who subsequently become pregnant following UFE.

Other UFE Warnings

  • When using the beads for UFE, do not use beads smaller than 700 μm.
  • An appropriate gynecologic work-up should be performed on all patients presenting for embolization of uterine fibroids (e.g., gynecologic history, fibroid imaging, endometrial sampling to rule out carcinoma in patients with abnormal menstrual bleeding).
  • The diagnosis of uterine sarcoma could be delayed by taking a non-surgical approach (such as UFE) to treating fibroids. It is important to pay close attention to warning signs for sarcoma (e.g., rapid tumor growth, postmenopausal with new uterine enlargement, MRI findings), and to conduct a more thorough work-up of such patients prior to recommending UFE. Recurrent or continued tumor growth following UFE should be considered a potential warning sign for sarcoma and surgery should be considered.

PAE-Specific Warnings

  • PAE does not reduce symptoms in all cases despite decreased prostate volume.
  • The prostate may continue to grow (with or without a reduction in symptoms).
  • An appropriate urological work-up should be performed on all patients (e.g., urological history and appropriate testing and examination, such as Prostate-Specific Antigen test, ultrasound, prostate imaging, and, when appropriate,biopsy to rule out prostate cancer).
  • The effects of prostatic embolization on male fertility have not been determined. Therefore, this procedure should not be performed on men who plan to father a child.

PRECAUTIONS

The following precaution statements provide important information for safe use of Bead Block Device. Observe all precautions provided in these instructions for use. Failure to do so may result in patient injury or product damage.

  • Do not use if the syringe or packaging appears damaged.
  • Select the size and quantity of beads appropriate for the pathology to be treated.
  • Sterile and single-use product. Do not reuse.
  • Consider upsizing the beads if angiographic evidence of embolization does not quickly appear evident duringinjection of the beads.
  • The color of the beads could be visible through the skin if injected into arteries feeding superficial tissues.

UFE-Specific Precautions

  • There is an increased chance of reflux of beads into unintended blood vessels as uterine artery flow diminishes. Comparison of angiographic endpoint and infarction rate in individual patients indicates that best results were obtained with an endpoint close to stasis. 

PAE-Specific Precautions

  • Patients with tortuous arterial supply or atherosclerotic arteries should be excluded from treatment.
  • There is an increased chance of reflux of beads into unintended blood vessels as prostatic artery flow diminishes. The embolization endpoint is to reach near stasis in order to avoid reflux.

ADVERSE EVENTS

Potential adverse events which may be associated with vascular embolization procedures or the use of Bead Block Device include but are not limited to:

  • Allergic reaction (to contrast)
  • Capillary bed saturation and tissue damage
  • Cerebral vascular accident (CVA)/stroke/transient ischemic attack (TIA)
  • Death
  • Foreign body reactions
  • Hematoma
  • Hemorrhage
  • Hypertension/hypotension
  • Infection/abscess/sepsis
  • Ischemia at an undesirable location
  • Ischemia/necrosis
  • Lesion/tumor rupture, injury
  • Neurological deficits, including cranial nerve palsies
  • Non-target embolization, for example:
    • Pancreatitis
    • Pulmonary embolism
  • Post-embolization syndrome (PES) (pain/discomfort, fever, and/or nausea/vomiting)
  • Recanalization
  • Thrombus/thrombosis, including clot in tip of catheter
  • Undesirable reflux or passage of beads into normal arteries adjacent to the targeted lesion/tumor, or through the lesion/tumor into other arteries or arterial beds
  • Vasospasm
  • Vessel trauma (aneurysm, dissection, injury, perforation, pseudoaneurysm, and/or rupture)

UFE-Specific Adverse Events

  • Amenorrhea
  • Constipation
  • Hysterectomy
  • Infection of the pelvic region
  • Premature ovarian failure (i.e., menopause)
  • Tissue passage, fibroid sloughing, or fibroid expulsion post-UFE
  • Uterine/ovarian necrosis, possibly requiring additional medical/surgical intervention
  • Vaginal discharge

PAE-Specific Adverse Events

  • Genitourinary tract infection
  • Non-targeted embolization of the rectum, bladder, scrotum, penis, or other areas
  • Post-PAE syndrome (may include general post-embolization symptoms, such as nausea, vomiting, regional pain,and fever, and urinary symptoms, such as dysuria or transient pollakiuria [frequent urge to urinate])
  • Sexual dysfunction or impaired fertility
  • Strictures of the urethra, rectum, or lower colon
  • Transient hematospermia
  • Transient hematuria, hematochezia
  • Transient urinary retention
  • Urethral or anal burning sensation

 

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