Indications, Safety, and Warnings OptiSphere Embolization Spheres

INDICATIONS

OptiSphere™ embolization spheres are intended for use in embolization of hypervascular tumors.


CONTRAINDICATIONS

  • Patients with a known hypersensitivity to porcine products
  • Coronary and intracerebral vascular use
  • In the pulmonary vasculature
  • Patients intolerant to vascular occlusion procedures
  • Vascular anatomy or blood flow precluding correct catheter placement or embolic injection
  • Presence or suspicion of vasospasm
  • Presence or likely onset of hemorrhage
  • Presence of severe atheromatous disease
  • Feeding arteries too small to accept the selected device
  • Presence of collateral vessel pathways potentially endangering normal territories during embolization
  • High flow arteriovenous shunts or fistula with luminal diameter greater than the selected size of the device
  • Vascular resistance peripheral to the feeding arteries precluding passage of the device into the lesion

WARNINGS

The OptiSphere embolization spheres are provided sterile for single use only. Reuse of a single-use device creates a potential risk of patient or user infections and may compromise device functionality, which may lead to illness or serious patient injury.

OptiSphere embolization spheres should not be used in the presence of infection. Gelatin-based materials may serve as a nidus for infection and abscess formation and have been reported to potentiate bacterial growth.


PRECAUTIONS

Do not use the OptiSphere embolization spheres if the packaging is damaged. A damaged package could indicate a breach of sterility or device damage.

Inspect the device for damage prior to use. Use of a damaged device could result in injury.

Prior to delivering OptiSphere embolization spheres, confirm that the selected delivery catheter (not included) meets the minimum required inner diameter for the selected sphere size. Use of a delivery catheter that does not meet the minimum inner diameter requirements may prevent delivery or result in injury.

Prior to delivering OptiSphere embolization spheres, confirm that the catheter is in the desired location. Failure to confirm appropriate catheter placement may result in non-target embolization. OptiSphere embolization spheres are available in a range of sizes and care should be taken to choose the appropriate size for the site intended to be treated. Improper size selection may result in injury.

If the delivery catheter becomes obstructed or significant resistance is encountered during injection, do not attempt to flush the catheter with excessive pressure as non-target embolization may occur.


ADVERSE EFFECTS

Potential adverse effects that may be associated with the OptiSphere embolization spheres include, but are not limited to, the following:

  • Abscess
  • Allergic reaction/anaphylaxis
  • Capillary bed occlusion and tissue damage/necrosis
  • Fluid encapsulation
  • Foreign body reactions
  • Hematoma
  • Hemorrhage
  • Infection
  • Inflammation
  • Ischemia at undesirable location
  • Non-target embolization
  • Pain
  • Post-embolization syndrome
  • Pulmonary embolism
  • Seroma
  • Transient hypertension
  • Vasospasm
  • Vessel or lesion rupture