CONVENIENT

Merit Medical’s new Embosphere PRO™ Prostatic Artery Embolization Kit combines the power and predictability of Embosphere® Microspheres with basic preparation and delivery tools for added convenience.

Each kit includes:

• (1) prefilled syringe of Embosphere® Microspheres, 300-500μm or 100-300μm
• (1) 10 mL Medallion® Syringe
• (1) 3 mL Medallion® Syringe
• (2) 1 mL Medallion® Syringes
• (1) 3-way Medallion® Stopcock, 1050 psi

PAE Clinical Summary with Embosphere® Microspheres

A composite database of 286 patients who underwent PAE using Embosphere® Microspheres for treatment of symptomatic benign prostatic hyperplasia (BPH) was analyzed to evaluate clinical outcomes. All patients were suffering from lower urinary tract symptoms (LUTS) due to BPH with International Prostate Symptom Scores (IPSS) of moderate to severe.

Post embolization, 97% of patients reported a decrease in their IPSS by at least 3 points, and 90% of patients dropped at least 1 symptom category, from severe to moderate or moderate to mild.

Most patients also experienced improvement in their Quality of Life score and a substantial decrease in prostate volume.

PREDICTABLE

Embosphere® Microspheres temporarily compress to facilitate smooth microcatheter passage

(A). Once through the microcatheter, Embosphere® Microspheres return to their original spherical shape and stated diameter

(B) for predictable, targeted delivery.

TARGETED

Embosphere® Microspheres show a direct correlation between the level of arterial occlusion and the size of the microspheres used, allowing for consistent, targeted occlusion.

ESTABLISHED

Embosphere® Microspheres are the most clinically studied and clinically utilized spherical embolic, having been proven:

• During more than 20 years of clinical use
• In more than 200 clinical articles, with more than 35 PAE-related

The Embosphere PRO Prostatic Artery Embolization Kit, which includes Embosphere® Microspheres, is indicated for use in the embolization of prostatic arteries for symptomatic benign prostatic hyperplasia (BPH).

CONTRAINDICATIONS

• Patients intolerant to occlusion procedures

• Vascular anatomy or blood flow that precludes catheter placement or embolic agent injection

• Presence or likely onset of vasospasm

• Presence or likely onset of hemorrhage

• Presence of severe atheromatous disease radiation side effects and whom they should contact if they show symptoms.

• Pay careful attention for signs of mistargeted embolization. During injection carefully monitor patient vital signs to include SaO2 (e.g., hypoxia, CNS changes). Consider terminating the procedure, investigating for possible shunting, or increasing microsphere size if any signs of mistargeting occur or patient symptoms develop.

• Consider upsizing the microspheres if angiographic evidence of embolization does not quickly appear evident during injection of the microspheres.

PRECAUTIONS

• Patients with known allergy to contrast medium may require corticosteroids prior to embolization.

• Additional evaluations or precautions may be necessary in managing periprocedural care for patients with the following conditions:

• Bleeding diathesis or hypercoagulative state

• Immunocompromise

• Do not use if the Embosphere syringe, plunger seal, or tray package appear damaged.

• Do not use if the kit’s syringes, stopcock, or pouch appear damaged.

• For single patient use only - contents supplied sterile - never reuse, reprocess, or resterilize the contents of a syringe that has been opened. Reusing, reprocessing or resterilizing may compromise the structural integrity of the device and or lead to device failure, which in turn may result in patient injury, illness or death. Reusing, reprocessing or resterilizing may also create a risk of contamination of the device and or cause patient infection or cross infection including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient. All procedures must be performed according to accepted aseptic technique.

• Do not connect the 20 mL syringe with Embosphere Microspheres directly to a microcatheter for embolic delivery, as a catheter occlusion may result.

• The syringe is intended for embolic use only. Do not use for any other application.

• Embolization with Embosphere Microspheres should only be performed by physicians who have received appropriate interventional embolization training in the region to be treated.

Vascular embolization is a high-risk procedure. Complications may occur at any time during or after the procedure, and may include, but are not limited to, the following:

• Paralysis resulting from untargeted embolization or ischemic injury from adjacent tissue edema

• Undesirable reflux or passage of Embosphere Microspheres into normal arteries adjacent to the targeted lesion or through the lesion into other arteries or arterial beds, such as the internal carotid artery, pulmonary, or coronary circulations

• Pulmonary embolism due to arterial venous shunting

• Ischemia at an undesirable location, including ischemic stroke, ischemic infarction (including myocardial infarction), and tissue necrosis

• Capillary bed occlusion and tissue damage

• Vessel or lesion rupture and hemorrhage

• Vasospasm

• Recanalization

• Foreign body reactions necessitating medical intervention

• Infection necessitating medical intervention

• Complications related to catheterization (e.g., hematoma at the site of entry, clot formation at the tip of the catheter and subsequent dislodgment, and nerve and/or circulatory injuries, which may result in leg injury)

• Allergic reaction to medications (e.g., analgesics)

• Allergic reaction to contrast media or embolic material

• Pain and/or rash, possibly delayed from the time of embolization

• Death

• Blindness, hearing loss, loss of smell, and/or paralysis

• Additional information is found in the Warnings section