ICESEED NEEDLE

Description of Event or Problem

IT WAS REPORTED THAT URETHRAL STENOSIS AND HEMATURIA OCCURRED. THIS RETROSPECTIVE STUDY WAS PERFORMED TO ANALYZE THE COST-EFFECTIVENESS OF PERCUTANEOUS CRYOABLATION (PCA) VERSUS ROBOT-ASSISTED PARTIAL NEPHRECTOMY (RAPN) FOR SMALL RENAL CELL CARCINOMA (RCC). 212 PCA (INCLUDING 155 WITH TRANSCATHETER ARTERIAL EMBOLIZATION) AND 119 RAPN CASES PERFORMED BETWEEN DECEMBER 2017 AND MAY 2022 WERE INCLUDED. PCA WAS PERFORMED USING AN ARGON-BASED CRYOABLATION SYSTEM (CRYOHIT OR VISUAL ICE) WITH 17-GAUGE CRYOPROBES (ICEROD, ICESEED, ICEROD 1.5 PLUS, OR ICE SPHERE) UNDER LOCAL OR GENERAL ANESTHESIA AND CT-FLUOROSCOPY GUIDANCE IN AN INTERVENTIONAL RADIOLOGY SUITE. FOR RCC NEAR VITAL ORGANS SUCH AS THE COLON, HYDRODISSECTION WAS ACHIEVED BY INFUSING A SALINE-2% CONTRAST MIXTURE TO CREATE A SAFE DISTANCE. THE NUMBER OF CRYOPROBES WAS DECIDED BY CONSENSUS. TYPICALLY, THREE WERE USED FOR RCCS GREATER THAN 15 MM, AND TWO FOR SMALL RCCS. AFTER INSERTION, CRYOABLATION WAS PERFORMED IN TWO 10-15 MIN FREEZING CYCLES, SEPARATED BY 2 OR MORE MINUTES OF PASSIVE THAWING. AFTER EACH CYCLE, COMPUTED TOMOGRAPHY (CT) IMAGING CONFIRMED THAT THE RCC WAS FULLY CONTAINED WITHIN THE ICE BALL, ENSURING AN ABLATION MARGIN OF AT LEAST 6 MM. IF COVERAGE WAS INCOMPLETE, ADDITIONAL FREEZE-THAW CYCLES WERE PERFORMED AFTER REPOSITIONING THE CRYOPROBES. RESULTS INFERRED THAT OVERALL, THE INCREMENTAL COST-EFFECTIVENESS RATIO WAS MORE FAVORABLE FOR PCA THAN FOR RAPN. PCA WAS ASSOCIATED WITH A SIGNIFICANTLY SHORTER PROCEDURE TIME AND HOSPITALIZATION DURATION WITH FEWER MAJOR COMPLICATIONS THAN THOSE ASSOCIATED WITH RAPN. THERE WERE THREE MAJOR COMPLICATIONS OBSERVED IN THE PCA POPULATION: 1 CASE OF URETHRAL STENOSIS (GRADE IIIA; CLAVIEN-DINDO CLASSIFICATION) AND 2 CASES OF HEMATURIA (GRADE IIIA; CLAVIEN-DINDO CLASSIFICATION).

Additional Manufacturer Narrative

B3: DATE OF EVENT- PUBLISH DATE SELECTED. E1: INITIAL REPORTER PHONE NUMBER- (B)(6). DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. BECAUSE THE PRODUCT LOT NUMBER IS UNKNOWN, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) #. UKA, M., IGUCHI, T., BEKKU, K., YAMANOI, T., MITSUHASHI, T., GOBARA, H., UMAKOSHI, N., KAWABATA, T., TOMITA, K., MATSUI, Y., ARAKI, M., & HIRAKI, T. (2025). PERCUTANEOUS CRYOABLATION VERSUS ROBOT-ASSISTED PARTIAL NEPHRECTOMY FOR SMALL RENAL CELL CARCINOMA: A RETROSPECTIVE COST ANALYSIS AT JAPANESE SINGLE-INSTITUTION. INTERNATIONAL JOURNAL OF CLINICAL ONCOLOGY, 30(6), 1621-1630. HTTPS://DOI.ORG/10.1007/S10147-025-02783-5.