CA20L2

Emprint™ Ablation System Single Antenna

Emprint™ percutaneous antennas with Thermosphere™ technology pair with the Emprint™ ablation generator to treat nonresectable liver tumors.

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Indications, Safety, and WarningsIndications

The Emprint™ ablation system is intended for use in percutaneous, laparoscopic, and intraoperative coagulation (ablation) of soft tissue, including partial or complete ablation of non-resectable liver tumors.

The Emprint™ ablation system is not intended for use in cardiac procedures.

The Emprint™ ablation system overlapping technique is only intended for use in the liver.

Contraindications

Microwave ablation procedures are not recommended for pregnant patients or patients with cardiac pacemakers or implanted electronic devices.

Residual risks

Residual risks include ascites, abscess, intra-abdominal abscesses, additional needle stick/puncture, atrial fibrillation, biliary stenosis, biloma, cancer (cancer seeding), cardiomyopathy, cholangitis, colonic perforation, death, delay of treatment, dyspnea, emphysema, exacerbation of lung disease, foreign body in patient, foreign body reaction, gastrointestinal fistula, haemobilia, hematoma, hemoptysis, hemorrhage, hemothorax, hepatic infarction, hepatic insufficiency, infection, inflammation, ischemia, necrosis, pain, peritonitis, pleural effusion, pneumothorax, post ablation syndrome, pulmonary/upper respiratory fistula, renal failure, renal fistula, seroma, tachycardia, urinary retention, urinary tract stenosis, wound dehiscence.

In the event that a serious incident has occurred related to device use, immediately report the event to the manufacturer, the competent authorities, and any other regulators as required.

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CA20L2

Emprint™ Ablation System Single Antenna

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CA20L2 Emprint™ Ablation System Single Antenna

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United States

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CA20L2

Emprint™ Ablation System Single Antenna