ICEfx™ Cryoablation System

Name: ICEFX™ Cryoablation System - Boston Scientific
Brand: Boston Scientific

Intended for the cryoablative destruction of tissue during minimally invasive percutaneous procedures, this compact system features a simplified procedural interface for ease of technical use.

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ICEfx™ Indications, Safety, and Warnings

Multi-Point 1.5 Thermal Sensor™ Indications, Safety, and Warnings

Cryoablation Needles: CX, Classic, and MRI Indications, Safety, and Warnings

ICEfx™ Cryoablation System

The ICEfx Cryoablation System is the next generation of ablation systems with a compact design and interface that offers predictable and seamless therapy delivery.

How it works

Why use the ICEfx Cryoablation System and Needles

The ICEfx Cryoablation System is a next-generation system with an upgraded interface and argon-only gas.

ICEfx Cryoablation System

This forward-looking ablation system with a compact design and easy-to-use interface allows for a predictable therapy delivery and technical operation.

Four independent channels supporting up to eight cryoablation needles
Two multi-point thermal sensors for sensing location and temperature for procedural performance
Easy to read freezing and thawing timers on the screen can be seen from the control room

CX Cryoablation Needles

Offers precise placement, ease of use, and control with a proprietary needle design. These argon-only needles feature thaw options with i-Thaw™ and FastThaw™ functionality.

Narrow, lightweight, and low-profile design with 1.5 mm and 2.1 mm shafts
Cautery function creates a uniform zone of coagulative necrosis

Classic Cryoablation Needles

Lightweight design with a sharp, three-facet needle tip, and shaft distance markers allow for optimal tumor coverage.

Straight or 90 needle configurations in a choice of lengths and diameters
Passive thawing is the only option with this argon-only system

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Ordering information

ICEfx cryoablation system

Catalog Number	ICEfx Cryoablation System and Accessories
FPRCH8000-02	ICEfx System, Console only
FPRCH8010-02	ICEfx Cart
FPRCH4000-02	Dual Tank Cylinder Gas Adapter, 5M PSI

Classic cryoablation needles

Cryoablation needles	Part number	Configuration	Shaft diameter (mm / gauge)	Shaft Length (cm)	Handle Color
IceSeed™ 1.5	FPRPR3202	Angled 90º	1.5 mm / 17 G	17.5 cm	Black
IceSeed™ 1.5	FPRPR3201	Straight	1.5 mm / 17 G	17.5 cm	Black
IceSphere™ 1.5 S	FPRPR3561	Angled 90º	1.5 mm / 17 G	17.5 cm	Yellow
IceRod™ 1.5 I-Thaw	FPRPR4009	Straight	1.5 mm / 17 G	17.5 cm	Red

CX cryoablation needles

Cryoablation needles	Part number	Configuration	Shaft diameter (mm / gauge)	Shaft Length (cm)	Handle color	Track ablation radial width / length
IcePearl™ 2.1 CX	FPRPR3603	Straight	2.1 mm / 14 G	17.5 cm	White	2.1 / 13 mm
IcePearl™ 2.1 CX	FPRPR3601	Angled 90º	2.1 mm / 14 G	17.5 cm	White	2.1 / 13 mm
IcePearl™ 2.1 CX L	FPRPR3617	Angled 90º	2.1 mm / 14 G	23 cm	White	2.1 / 13 mm
IceForce™ 2.1 CX	FPRPR3604	Straight	2.1 mm / 14 G	17.5 cm	Gray	2.5 / 29 mm
IceForce™ 2.1 CX	FPRPR3602	Angled 90º	2.1 mm / 14 G	17.5 cm	Gray	2.5 / 29 mm
IceForce™ 2.1 CX L	FPRPR3618	Angled 90º	2.1 mm / 14 G	23 cm	Gray	2.5 / 29 mm
IceRod™ 1.5 CX	FPRPR3533	Angled 90º	1.5 mm / 17 G	17.5 cm	Red	2.3 / 30 mm
IceSphere™ 1.5 CX	FPRPR3573	Angled 90º	1.5 mm / 17 G	17.5 cm	Yellow	1.7 / 14 mm
IceSeed™ 1.5 CX	H7493967433170	Angled 90º	1.5 mm / 17 G	17.5 cm	Black	1.6 / 14 mm
IceSeed™ 1.5 CX S	H7493967233100	Angled 90º	1.5 mm / 17 G	10 cm	Black	1.6 / 14 mm

Training resources

Sign up to learn about Boston Scientific events and cryoablation education opportunities for bone, kidney, lung and nerve indications.

Cryoablation education

Online medical training and education courses

The EDUCARE online platform makes healthcare education and training more relevant, more comprehensive, more personal, and more accessible. Register to access a library of procedural videos, case studies, training resources, and events.

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ICEfx Brochure

Learn about the ICEfx Cryoablation System offering reliable performance and ease of operation, featuring customizable cycle programming, adjustable freeze cycles, and a user-friendly interface for precise iceball control.

ICEfx Brochure

Needles Brochures

Learn about the IceSeed CX Needles, which can treat various tumors and lesions with a shorter shaft for sculptable iceball size.

IceSeed 1.5 CX Needle Brochure

Learn about the proprietary design of CX Needles, offering precise placement and helium-free thaw, which reduce setup time and costs.

CX Cryoablation Needles Brochure

CX Needles Isotherm Guide

Use the isotherm guide to aid in treatment planning. View isotherm sizes for CX Needles, ranging from 1 to 4 needles used.

CX Needles Isotherm Guide

Bone cryoablation

Treating Painful Bone Metastases with Cryoablation: Esther’s Story

See Esther’s journey through her cancer diagnosis and her decision to be treated with cryoablation for painful bone mets.

Bone is the most common site of metastatic cancer. Bone metastasis are associated with bone pain resulting in significant decreased physical function and quality of life (QOL). External beam radiation therapy is the standard for treatment of patients with painful bone metastases, along with opioids and non-opioid analgesics. Unfortunately, the time to pain relief for radiation therapy is 1-2 months and for many patients the pain can persist after radiation therapy. Cryoablation for painful bone metastases allows for rapid and durable pain palliation.

The MOTION study

Cryoablation for Palliation of Painful Bone Metastases: The MOTION Multicenter Study

This multicenter, prospective, single arm, phase II study examined the impact of the treatment of a painful bone metastatic lesion in each patient.

Study objective

The primary objective was to evaluate the efficacy of cryoablation for pain palliation of bone metastases from baseline to 8 weeks after cryoablation in worst pain in the last 24 hours.
Separate evaluations of ancillary efficacy endpoints were also made through 24 weeks.

Key results

Figure 1

bar chart showing change in worst pain in last 24 hours through 24 weeks.

The primary efficacy endpoint of mean change in worst pain in last 24 hours from baseline to week 8 was 2.61 ± 0.43 points (95% CI: -3.45, -1.78) as shown in Figure 1. Clinically meaningful changes from baseline were observed at all time points after week 8. In the completed case analysis (n = 64), mean pain scores improved by 2 points as early as week 1 and continued through week 24 and the 92% of participants achieved palliation (59/64), with median time to maximal pain relief of 39.0 days (95% CI: 43.7, 72.4 days; n = 59). Most participants achieved their maximum palliation by week 1 (33.9%; 20 of 59), week 4 (25.4%; 15 of 59), or week 12 (15.3%; nine of 59).

Figure 2

line chart showing change in quality of life through 24 weeks.

Quality of life consistently improved over 6 months (Fig 2). The overall treatment effect was rated “better than at the last visit” by 60.9% (39 of 64) and 30% (11 of 37) of participants at weeks 1 and 24, respectively; treatment effect was rated “worse than at the last visit” by 13% (eight of 64) and 11% (four of 37) participants at weeks 1 and 24, respectively.

Conclusion

Overall, the data shows a rapid and durable pain relief along with a decrease in MEDD and a corresponding increase in the quality of life for patients.

Bone resources

MOTION publication summary

Bone Data Pack

Kidney cryoablation

Percutaneous cryoablation (PCA) for renal cell carcinoma (RCC) has grown rapidly over the last decade. This is due in large part to a growing body of evidence demonstrating comparable outcomes with partial nephrectomy, but with decreased complications and greater preservation of renal function. Similarly, cryoablation has an advantage over heat-based ablation modalities, allowing for visualization of the ablation zone and preservation of critical structures, even in central lesions.

EuRECA study overview

The largest, prospective, real-world, multicenter, multidisciplinary study on the use of cryoablation for treatment of renal cell carcinoma (RCC) in 1700 patients.

See full data set

Urology Initiated

A joint mission between urologists and interventional radiologists and administered through the Bristol Urological Institute

Over 1400 biopsy-proven RCC patients

Data from over 900 treatments with biopsy-proven RCC with an almost 5-year follow-up

15 centers across 5 European countries

This Boston Scientific sponsored study began in 2014 and ended in 2020.

Outcomes comparison

How do cryoablation and ablation compare to partial nephrectomy across key outcomes?

Metric	How does cryo/ablation compare to partial nephrectomy (PN)	Limitations
Local recurrence free survival*	Level 1 data needed	Older data, meta-analyses include RF
Metastatic-free survival*	Ablation = PN
Cancer-specific survival*	Ablation = PN
Overall survival*	Level 1 data needed	Selection bias - ablation patients tend to be older with more comorbidities
Renal Function	Cryo/ablation > PN
Safety	Cryo/ablation > PN
Cost	Cryo/ablation > PN
Quality of life	Cryo/ablation > PN

*Oncological outcomes: Similar = | Better >

Case studies

Treatment of lesion adjacent to colon

Adjacent Structures and RCC

A 66-year-old man presented with 2.0 cm x 2.1 cm left sided, endophytic RCC and biopsy confirmed clear cell renal cell carcinoma. Initial CR images on the day of the procedure demonstrated the lesion and adjacent colon, which would likely be injured if not moved. Cryoablation was performed with three IceRod™ 1.5 CX Needles for treatment and a yueh needle was utilized to introduce normal saline to hydrodissect away the adjacent colon. The patient had no pain or significant complaints; he was discharged and returned to work the same day of the procedure. He continues to be without evidence of residual/recurrent disease one-year later.

Shamar Young, MD I University of Minnesota I Minneapolis, MN

Cryoablation needle trajectory angled to protect critical kidney structure

Using the Trajectory of the Needle to Protect Critical Structures

A 53-year-old man presented with 2.5 cm x 2.3 cm endophytic RCC in the anterior aspect of the lower pole of the left kidney. Cryoablation was performed with one IceForce™ 2.1 CX Needle. The tip of the needle was pointed toward the ureter since lethal ice only extends 5 mm beyond the tip of the needle. The patient was discharged the same day and follow-up imaging demonstrated no residual or recurrent disease 12-months post ablation.

AJ Gunn, MD I University of Alabama at Birmingham I Birmingham, AL

Cryoablation of 7cm left renal tumor

Cryoablation of 7 cm Renal Tumor after Previous Contralateral Nephrectomy

A 78-year-old man presented with right kidney multifocal RCC with vein invasion and concurrent 7 cm left anterior conventional clear cell RCC. The right tumor was treated with nephrectomy and the left tumor was treated with cryoablation 3 months after the nephrectomy. Hydrodissection was used to protect adjacent structures and 7 IceRod™ 1.5 PLUS needles were used to treat. There were no reported adverse events and early follow-up imaging of the left kidney confirmed adequate ablation.

Alex King, MD I University Hospital Southampton I Southampton, UK

Kidney resources

Kidney data pack

Kidney cryoablation brochure

Kidney cancer guideline summary

Renal Breen publication summary

Renal Rosenberg publication summary

Lung cryoablation

Percutaneous cryoablation (PCA) is a tool for treating primary and metastatic lung tumors. Typically, patients are non-surgical candidates with primary non-small cell or oligometastatic lung cancer. Lung cryoablation preserves pulmonary function, offers repeatability for future metastases, and can treat multiple lung tumors during a single treatment. Unlike other ablative treatments, cryoablation provides excellent local tumor control. Patients typically have a short hospital stay and report low incidence of pre-procedural and post-procedural pain.